Welcome to today's webinar, Managing Clinical and Translational Research During the COVID. My name is Cristian Rolfo. I will be the moderator today in this webinar. Next. This is the amazing panel that you can back one. This is the amazing panel that we have today of speakers, and it's a pleasure to introduce Antoniette Bosniak, that is the Director for Clinical Research at the Hillman Cancer Center, University of Pittsburgh. Joy Tipate, Professor of Medicine, Associate Vice Director of the Clinical Research in Northwestern University in Chicago. Katherine Pietanza, Associate Director, Vice President of Clinical Research in Merck. Berkley Rose, that is the Oncology Nurse Navigator of the University of Chicago. And finally, Amy Moore, that is Director of Science and Research to Go to Foundation for Lung Cancer. Next. Here are some notes for the housekeeping for you guys. If you would like to download today's slide, you can access them by clicking in the link to the webinar page in the chat. You will also be able to find the video recording of the webinar in the link in the next week. The email we'll send you today, so with the instructions to claim for the CME credit, so be aware about this, and in the end of the day, you will receive this email. Your camera and microphone will remain off for this webinar, and please enter your questions that you have in the Q&A discussion into the Q&A section at the bottom of some webinar. You might use the chat function for other discussions, and we will not be using the raising hand fusion for questions. We plan to have a panel discussion for Q&A session for the presentations, and please enter, as I said before, your questions in the Q&A section at any point during the talks. Next one. Here we have the speaker disclosures. I would like to introduce the first speaker, Professor Antoniette Bosniak. Tony, the floor is yours. Okay, thank you, Christian. My chore will be to talk about managing clinical research during the COVID pandemic, and I thought it would be worthwhile if I talked about what we did at my institution, just to give you some examples, so my talk will be primarily centered around that. Next slide. In order to do that, I would like to tell you what my institution is like. It is not really an advertisement, but I think it is important to know about the size of the institution and how many patients we see. I work at the Hillman Cancer Center. This is in Pittsburgh, and we actually have a hub, a central hub, as well as a number of satellites, and we actually encompass most of Western Pennsylvania, and we actually are into New York and Ohio as well. We have 180 affiliated oncologists, including our satellites, where we do clinical research. We are a state-of-the-art facility. We see 36,000 patients per year. To give you an idea of the size of our operation, we have over 200 clinical research staff, and we service nearly 500 active clinical trials. In 2019, we actually had 2,000 accruals to interventional trials, with more than 1,000 of these accruals to therapeutic trials, so we are a very active clinical research area. Next slide. Let's see what happened in 2020, when we had to deal with COVID. This is actually a graph of our clinical trial accrual by month for 2020, and you can see in January where we were, and the upper, the blue line is all the interventional trials. The red line represents our therapeutic trials, so you can see that in the first wave of COVID in the spring, we had a dip, primarily in the interventional trials, but the therapeutic trials went down around 40-50%. After we regrouped and incorporated some changes, you can see that we recovered quite well. We were doing well through the summer, and then in our second wave, we had a little bit of a dip, but we actually did maintain our clinical trials. So how did we do that? Let's discuss what we did. So we stratified our clinical trials based on the importance of them with regard to patients and risk. So there were Tier 1 trials. These were studies with high direct benefit to research participants. So this was pretty much most of our therapeutic trials that treated patients. There were also trials that would have a high public impact, for instance, trials with COVID-19 research. An example of one of the trials is listed below. This is a lung cancer trial looking at immunotherapy, sequencing of immunotherapy and chemotherapy, and this was considered a Tier 1 trial. Next slide. So what is a Tier 2 trial? Well, this is a trial that actually where the clinical care and the research intervention are interrelated. These are studies in high-risk diseases where if you delay the clinical discovery of what they're trying to do, you could have some impact on patient outcomes. So an example of one of these trials is a trial of mine, and that is a randomized non-inferiority trial looking at length of treatment of PD-1, PD-L1 inhibitors. And this is a trial in which patients are already being treated, and we are just looking at their length of treatment. So this would qualify for a Tier 2 study. Next slide. A Tier 3 study would be trials that have low direct benefit to patients, and these would be cohort, natural history studies, quality of life studies, where their data collection has limited impact. An example of this would be an outcome and quality of life collection of patients receiving treatment for cervical cancer. You can see the example there. Now, even during the pandemic, these trials remained open, but only if we could collect data without being in person with the patient. So if things could be done by telemedicine or by phone call, these trials did continue. Next slide. There was guidance from CTEP and the FDA with regard to promoting patient and staff safety, but still allow continuation of these clinical trials. Some of the things that happened were visits were sometimes delayed or switched to telemedicine. Lab imaging could be done out of window, and treatment delays could also be done. This was also at the discretion of the responsible investigator. If it was safe for the patient, then delays could be done. Biospecimen collection delays were allowed. There was no requirement for protocol amendments or corrective action plans in order to document these major deviations because of the public health emergency. Remote monitoring was allowed in lieu of onsite monitoring, and also remote consents were also not considered a major deviation. Next slide. In terms of what we did at our institution, for clinical and research safety of the clinical and research staff, we reduced onsite staffing. We had flexible schedules to allow people to work from home. Some of these staff work in small cubicles, so we had to do this for their safety. We arranged some transportation. We provided IT sources to allow them to work from home. Management was available onsite in a rotational basis. All regulatory staff worked from home. We maintained tracking of at-risk employees if they got exposed to COVID, and increased testing was done based on CDC guidelines through the employee health. Next slide. Next slide. In terms of patient safety, we converted all nonessential visits to virtual visits via telemedicine, and this was somewhat challenging, and I'm sure that there will be questions in terms of how we did this. Actually, in the clinic, we had an IT person helping us do this, but some of the challenges came from the patients with regard to telemedicine. Staff screening and PPE during visits, we had no visitors. The patient only could be seen in the clinic. We did make exceptions on a patient-by-patient basis. If a new treatment was going to be discussed or if scans that indicated progression of disease were going to be discussed, we tried to arrange for a visitor to come with the patient. We did pre-visit phone calls for COVID screening and thermal scanners at the entrance and social distancing in the waiting rooms. Next slide. So, in terms of a summary of how we adapted to the pandemic, we prioritized our clinical trials. We stopped actually all on-site monitoring. We implemented new remote monitoring agreements and EMR remote access with our trial sponsors. We adjusted staffing, managed new consents based on local guidelines. We used telemedicine, as I mentioned before. And we actually, it was business as usual. All protocol review committees, all data safety monitoring committees were continued, and these were done via Zoom or Teams meetings in order to ensure that we were monitoring our clinical trials. Next slide. So, what about the future? I think we still have to continue this, even in the post-pandemic world. We don't know when this is going to end, and we also don't know if it might recur. So, I think some of the things that could be done is that you have to establish remote EMR access and monitoring as a standard. It has to be in all protocol contracts to begin with, so this can be done. E-consents for the Tier 2 and the Tier 3 trials, remote data collection, clinical trial prioritization right up front. And when we write clinical trials, we have to make them a little less restrictive, and we have to make sure that they can work during a pandemic or during a medical emergency. It's something we never expected. And I think that every institution has to have standard operating procedures that will protect staff and patients during this period of time. You have to be prepared. Thank you. Thank you very much, Antoniette, for the great presentation. We'll go now to Jyoti. Thanks so much. So, I'm Jyoti Patel. I'm the Vice Chair of Clinical Research at Northwestern in the Department of Medicine, and so much of what I do is certainly as a clinical investigator, but when we looked at our institution and understood sort of the very wide array of research activities that go on on a busy academic campus, we really had to navigate through a lot over these 10 months. So, next slide. So, certainly, Tony has addressed just the significant impact that we all suffered initially from the pandemic, but really the lessons learned. And I would say, similar to Pittsburgh, many institutions actually regained clinical trial accrual and sort of have closed this year with many patients on interventional clinical trials. Next slide, please. But I think there are three major questions that we really need to grapple with as we move forward and think about the research enterprise. So, I think the first one was, you know, what should we be doing as a research community to really address the COVID-19 pandemic and its impact on cancer care and delivery? And so, that was changing laboratories' focus to COVID-related issues, really thinking about how we're looking at our infrastructure to deliver the best care and the highest, the cancer trials with potentially the highest benefit to patients. Another question we needed to answer was really, what do we do with the ongoing research that millions of people across the country are participating in currently? And then, finally, as Tony touched upon, really, what can we learn from the pandemic? Really, what can we learn from this crisis to be better the next time? What can we do as a community and a health learning system to improve our outcomes and access for all? Next slide. So, we think about, really, the impact of these clinical trials. We need to think about, you know, how vast our research enterprise is. So, this is data from just earlier this week from clinicaltrials.gov. And as you see, we have over 360,000 clinical trials registered on the clinicaltrials.gov website. And you can imagine that the implications and collateral damage for such a large industry are significant. But what do we really do at this point when we have so many resources that impact so many of us? Next slide. And the impact is certainly, you know, we have felt it, I think, through our clinical trials, through our interventional trials. But we need to understand that the research that we do is quite broad. And so, if we think about the trials that are currently registered, we can see that this is a global problem. So, only a third of all of these trials are in the U.S. alone. The non-U.S. trials or global trials are 50 percent of all trials that we see. And that the array of trials is significant. So, although almost 80 percent of trials are interventional, many of those are behavioral. And then we have a number of observational studies, as well as a small number of expanded access studies. Next slide. So, we tier our research and we think about clinical trials. We want to provide access to protocols when alternatives don't exist. So, those are the high-priority trials that continue to most centers, even from the beginning of the pandemic. But then we really need to think about limiting risk to our potential participants in some of these observational and biobanking trials, to our research staff, and then to really think about community exposure and the efforts many of us made at our medical centers. These non-essential trials are the ones that I really want to focus on. Those are primarily observational. They're behavioral studies. They're biobanking studies and don't have direct potential benefit to the hundreds of thousands of people that volunteer to be on these studies, but have significant impact. Next. To the many people that we will be seeing in the decades to come. And so, although trials in the immediate period are compromised, and we had wonderful guidance from the FDA, we're really thinking about the trajectory of multi-year trials and the impact on discovery and innovation a decade down the road. And so, that's even after this current pandemic in what we've heard so often as our new normal, but sort of our lives in 2022 and beyond. Next slide. So, the collateral damage in terms of all biomedical research that many of us faced when we first had shelter-in-place was that research staff was essentially told to stay at home. Laboratories were closed initially in the pandemic. Communications were curtailed. We had conferences that were canceled and, again, have pivoted so nicely now to having virtual conferences, as Tony had referenced. There's a lot of business as usual now. We're all facile in using things like Zoom and Teams. But we've faced issues with supply chain, which continue. And then, I think very notably is that many of our healthcare systems have had a huge financial impact. And so, the extra money to do some of this other research has really been tightened up, and many universities have really tightened up purse strings for exploratory studies and for extraneous staff. Next slide. So, the research guidance that really came from this has been sort of multilayered and has changed over time. When the pandemic first happened, these are slides from my institution from Northwestern, the feeling was that we would all be back in campus in a good place in the fall. Clearly, that pivoted, and we have had to deal with multiple layers of university, city, and state policies. We have instituted that laboratories come back with good pandemic research plans, so PIs must submit plans for protecting research staff and personnel. There are significant issues in already constrained laboratory spaces about working side by side. And so, at Northwestern in Chicago guidance, you can have two to three people per 500 square feet, as you can imagine, a busy laboratory bench. It's very difficult to get the work done. Many of our laboratories are now having phases or shifts of people, so working at different times, coming in on weekends, but certainly there's been a fluidity. And these pandemic research plans need to touch upon so many pieces of the research enterprise from core facilities. Certainly, we've talked about human participant research and the implications that has for observational studies and biospecimen studies, but also basic things like animal care facilities. How do we keep these up and going, again, with all of the constraints and supply chain availability of extra funds and communications? Next slide. What we've seen that's been really difficult, and I think that we will see for the next coming years is the implication it's had for our translational scientists and particularly early career folks. So often for the first months, for two to three months, people were unable to go to the laboratories, they were unable to work on their grants or training activities. And there was a push to get all available people in hospitals to do clinical care. And that was sort of the health emergency period. And so there has been significant, there's the NIH and the NCI have been very flexible with stipends and salaries. We're able to move people to appropriate working times now that many parts of the country have a robust workforce. Despite a busy pandemic, people are coming back into the labs, but they don't have to make up that salary or those months of lost time. They're able to divert and push stipends down the road a little bit. Next slide. This research time, again, particularly for young investigators in which they may have three or four years for a particular grant, the NIH has been very flexible in letting these early stage investigators push down and extend time for fellowships and career development. Certainly at our institution, we've seen a lot of PTSP trainees in particular have significant stress about this time, the short time of losing a year of fellowship, for example, and what implications it will have on their career development. And institutionally, I think we all need to be very supportive because we don't want to lose this generation of investigators. Next slide. What has really come from this really difficult year, though, is I think something that we should all be proud of as a medical community. We've certainly learned to pivot, as trite as it sounds. We've been able to do research that's been decentralized and more patient-centered. But I think the real gems of all of this have been how collaborative we've been. Suddenly, we were able to work together as a community, share much more information than we ever had a decade prior to this. We were able to prioritize our shared commitment to our patients. And then we were also able to follow the best science. So things that we learned from COVID, we were able to apply to oncology. Some of the hematologic drugs we were able to test in COVID, in patients who were infected with COVID. And so this, I think, is important for us to show that we can always follow the best science and we can reassess, look at the landscape, and then come out ahead. So I'd argue that this has really been a way to push us to some of the best and most innovative care. So thank you. Thank you very much, Jyoti. We will discuss, obviously, you give us several points for discussions. And we go now for Katie Pietanza. I would like to thank her for joining us with the perspective of the pharma industry. Katie? Good morning, and thank you all for inviting me to be at this event. I'm Katie Pietanza. I lead the Thoracic Malignancies Clinical Development Program at Merck, and I'm very happy to be here this morning. Next slide. Very early on, as the pandemic occurred and we were sheltered in place, we knew we had to move forward and be innovative. The two most important things that we thought we needed to do was to continue enrollment on clinical trials and ensure the supply chain of investigational agents. You heard from Jyoti how that's been a big problem. So for us, most of clinical development has been work from home since the pandemic started in March. But manufacturing is needed to go into the workplace to, again, ensure that supply chain. And we were very adamant that that continued. We needed to be innovative. We needed to ensure that our trials continued while people were not allowed in facilities. And so we did allow for the implementation of trial processes through alternative methods if they were needed. Two important things that we did was allow imaging off-site. The investigators had to provide guidance on image acquisition as per protocol. We needed to ensure that laboratory assessments continued. And again, investigators needed to provide support and oversight. With compliance from local regulations and site processes, we allowed telemedicine as a force with the approval from the clinical directors on each of the trials. We implemented home health visits to allow home infusion of study intervention. And we allowed shipment of oral investigational products, again, dependent on country regulations. We encouraged investigators to maintain study conduct, continue the clinical trial protocol procedures and eligibility and prohibited medications, but left it up to the investigators to assess the risks and the benefits of continuing the participants on trials and utilizing best practices as issues arose. We referred physicians to guidance drafted by the FDA, EMA and organizations such as ASCO because these were found to be extremely useful. And we reinforced safety monitoring as per standard adverse event and serious adverse event reporting. Next slide. So how do we move forward with the impact of COVID-19 on ongoing trials? We know that enrollment of participants to studies has slowed from original productions. And so our analyses obviously are being protracted and pushed off. And this has been seen universally throughout industry. We have noted that patients have developed COVID-19 infections from grade one to grade five events. Investigators, again, have been encouraged to evaluate the risks and benefits of continuing treatment, interrupting and discontinuing study intervention as needed. The treatment delays and interruptions as well as delays and assessments either due to travel site closures or COVID-19 infections. We've managed these through the windows allowed in the trial and had ongoing discussions with sponsors and investigators. Deviations from protocol specified procedures have occurred. And these have been for safety assessments, imaging, as well as study visits. And we've required that documentation of all COVID-19 related protocols use a prefix of COVID-19. This has been specified by the FDA and will help us to at later time points during the analysis, assess the impact of COVID-19 on our trials. I think that Jyoti and Tony mentioned this, but monitoring sites has continued and it's been variable, but we have allowed remote monitoring in accordance with local laws and with adequate oversight from managers. And this has been very important and has allowed us really to continue all of our work at the sites and with the investigators. Next slide. So how do we move forward in the midst of the COVID-19 pandemic? And as Jyoti pointed out, you know, the next emergency that we have, and Tony pointed this out as well. So we're continuing to enroll. That's a top priority for us. We continue to develop studies with novel options that can lead to improvements in patients with cancer. We try to be flexible in our study procedures. We have processes in place. So important for the analysis of our studies is going to be the processes that are needed for COVID-19 reporting of infections, severity of disease, study interruptions, discontinuations and deviations. And there are statistical guidance is available for treatment losses in death due to COVID-19. For example, the FDA has acknowledged that we might need pre-specified analyses, sensitivity analyses due to COVID-19 impact if needed. The FDA NEMA guidance is in place to assist for affected trials. So we will have to discuss with the FDA any additional analyses that might be needed due to the implemented contingency measures that we've used for safety and efficacy. Further, again, the pre-specified analysis will need to be determined and we'll have to discuss with the FDA how to manage the COVID-19 deviations. And these will have to be done for databases block. Where patients are discontinued from study intervention, every effort has been made to keep patients on trial and be followed for safety and efficacy endpoints. And as I said before, as new trials are being planned, that trial procedures and study interventions are closely considered as the pandemic continues. So thank you very much. So we've tried very hard to keep our processes in place and move forward in the midst of the pandemic. Thank you, Cathy. So we will discuss certainly. You also have a lot of points that we need to back there and the reality that we have in the United States could be also different than we have in other places of the world and it would be nice to know your perspective about that as well. So we have now Berkeley Rose, our nurse navigator. So Berkeley, the floor is yours. Hello, everyone. My name is Berkeley Rose. I am an oncology nurse navigator at the University of Chicago in the mesothelioma program. And I'll be discussing clinical trials during COVID-19 from a nursing perspective. Next slide. Oncology nursing during COVID-19. Nurses are the largest healthcare professional group providing frontline care. Globally, 20.7 million out of 43.5 million healthcare workers are nurses. The nursing role and contribution during the pandemic is more relevant than ever before. Nurses are the cornerstone of health services in the frontline setting. In leadership and education, nurses are developing and implementing new policies on standards of care. Cancer patients have three and a half times higher risk of severe COVID-19 disease than other patient groups. This creates pressure on healthcare systems as well as nurses to meet the demands of the pandemic while addressing the needs of the oncology patient population. Next slide. COVID-19 oncology nursing challenges. Oncology nurses are adapting to new information and frequently changing regulations. As we previously discussed, there's a need to reallocate resources, both human and budget. And many nurses were reallocated during the initial phase of the pandemic to COVID-19 care areas. Initially during the pandemic, there was a cancellation or postponement of non-curative chemotherapy and elective surgeries, which was particularly challenging for nurses to communicate to patients. Initially as well, there were challenges obtaining appropriate personal protective equipment for nurses to safely care for patients during COVID-19. However, we've now leveled out and supply can meet demand. Social distancing requirements resulted in fewer staff helping on site. And there was a need to communicate via telehealth instead of in person. Visitor restrictions resulted in less family support for patients, leading into one of the major impacts on our patients, the psychological impact of social isolation on patients requiring enhanced supportive care resources. Anxiety and depression are already prevalent in the oncology patient population. And adding a layer of a pandemic requiring social distancing and the lack of comfort from loved ones in person was very challenging for patients. And so nurses have been really utilizing palliative care, symptom management and psych oncology services to help patients cope with the day-to-day of the pandemic. Next slide. The impact of the COVID-19 pandemic on clinical trials and participation in research. As we all know, clinical trials are key to improving the management and developing potential cures for multiple malignancies. As we've discussed, drug device and biological product trials were immediately impacted by the pandemic, leading to many potential barriers for nurses working with patients on trials, such as facility closures, mandatory quarantines and travel restrictions. This led to many phone calls and questions on how we as staff would keep patients safe and participating in clinical trials. Next slide. Clinical trials nursing during COVID-19. Clinical trials nursing is complex in itself, and the pandemic certainly added layers of communication and a lot of behind the scenes work done by nursing. This involved communication with principal investigators, study sponsors, regulatory staff, research coordinators, and data management on new processes and workflow and how we conducted these effectively with different remote work models. It required prioritizing necessary clinical trial safety monitoring of patients and integrating the COVID-19 protocols. Overcoming barriers for screening and enrollment and creating new logistical workflows when many staff work remotely. To overcome some of these barriers, some of the things we did at University of Chicago was utilize our local oncology networks to obtain screening assessments such as labs, ECGs, echocardiograms locally to avoid unnecessary travel for patients and risking exposure. Nurses have also utilized telehealth for toxicity management to provide equivalent quality toxicity assessments for patients on clinical trials. As well as working with study sponsors on adjusting protocol requirements to be patient centered and allow, for example, shipment of oral investigational drugs and where this would be helpful and pertinent is perhaps patients who are clinically stable and doing well on an oral investigational drug trial and perhaps avoiding in-person visits and utilizing our virtual platforms for video visits to assess and monitor and having them only come in person when restaging or re-imaging is necessary. Nurses have also, above all, been practicing diligent documentation via telehealth for optimal data collection and monitoring. This way, anyone on the care team working remotely, especially study monitors, understand and know what the plan is for the patient and make sure that we are still safely monitoring our patients on trials. Next slide. Caring for patients on clinical trials during COVID-19. The pandemic not only has added behind the scenes work but also added much additional work on the front lines. Nurses are communicating with patients on new policies and procedures such as masking and social distancing requirements while on campus. But not only are we making sure patients adhere to these requirements on campus, but we're also educating patients on safe masking and hand hygiene as well as social distancing practices at home to prevent major COVID-19 related serious adverse events that could potentially interfere with their treatment. We're monitoring patients for any potential symptoms of COVID-19 prior to them even coming on campus and advising testing when appropriate and really trying to avoid any patients with potential symptoms from coming in and jeopardizing other patients and staff and making sure we provide them all the resources possible to get testing as promptly as they can. We're utilizing telehealth resources to accommodate patient safety and allow for appropriate monitoring of patients on trial. This includes enhancing our telehealth nursing skills as well as educating patients on the various telehealth platforms and resources, not only making sure we understand how to use the various platforms, but also that they have access and can use those platforms to make visits, virtual visits, successful on both ends. One of the most important aspects of nursing care during COVID-19 for patients on clinical trials is building and utilizing our already established relationships within the oncology community to help accommodate patients and not only provide them the same quality of care, but also make sure we are safely caring for them and monitoring them during COVID-19 while on trial. Thank you. Next slide. Those are my references. Thank you, Barclay. I would like to remind all the participants that you can enter any questions or any time in the Q&A section at the bottom of the Zoom website. We will go now for the last speaker, and it's my pleasure to introduce Amy Moore. She's a very good friend and working very hard for this GoTo Foundation on lung cancer that is an advocacy organization that is doing a lot for our patients. So, Amy. Thank you, Christian, and it's good to be with you all today. You know, my background is I'm trained as a virologist, but have since been part of the advocacy community for lung cancer for almost three years now, and so, you know, I'm very focused on issues at the intersection of the pandemic and lung cancer care. So, next slide. Today, I want to talk about some of the work that the lung cancer patient advocacy groups here in the U.S. have done to come together to address the needs of our patient community. So, I'll be discussing efforts conducted on behalf of the advocacy groups shown here. Next slide, please. This is our advocacy timeline. We issued our first joint statement on the COVID-19 pandemic on March 3, roughly a week before the World Health Organization declared a pandemic. We then collaborated with ISLC on two podcasts, one at the end of March and one at the end of May, with the one in May being most relevant to our discussion today with a focus on impacts of the pandemic on basic and clinical lung cancer research. We then conducted a rapid needs assessment survey in early June to better understand the needs of our community so that we could best serve them as the pandemic continued. We've also seen fruits of our collaboration with the recent awarding of an NCI U54 grant to a multi-institutional team to better understand the antibody response as well as determinants of disease progression in patients with lung cancer infected with COVID-19. Next slide, please. So again, in early June, we conducted a rapid needs assessment in which we asked questions across three domains, one, general information about COVID-19, two, what happens if I get COVID-19, and three, impacts of the pandemic on lung cancer care. So here, I just want to highlight the top concerns across each domain for our patient and caregiver community. In the domain of general information about the pandemic, patients want to know how they would know when it was safe to return to normal activities, how to reduce their risk of infection, as well as symptoms of COVID-19 and how it affects the body. In the domain of what happens if I get COVID-19, there was interest in treatment and vaccines for COVID-19, what aspects of lung cancer put them at greater risk for severe disease, as well as what we know about developing immunity to the virus. Finally, in the domain of impacts on lung cancer care, patients were concerned about how the pandemic could delay or terminate lung cancer research, what would happen for them specifically. There were fears about patients being triaged out of treatment if resources were limited at hospitals. Also, there were concerns that lung cancer diagnosis, treatment, or follow-up care would be delayed or canceled. Next slide, please. I would say that we've seen an evolution of patient concerns over time. During the first wave of the pandemic last spring, there was a lot of interest about general information about the virus and how patients could stay safe, the risk of everyday activities. Also, fears of triage, and I've put an asterisk there because I think what we're seeing now is that some of those early concerns are starting to resurface, and I'll touch on that in just a moment. During the post-shelter-in-place period, patients were beginning to tackle how they could safely navigate getting their care. There were fears of exposure when visiting medical facilities, and also the challenges around logistics of care, transportation, how to safely get to and from appointments, for example. As we've been in the midst of the winter surge and are now entering the second year of the pandemic, I would say that we're seeing some resurgence of old fears with increased reports of the challenges in LA, for example, where oxygen is being rationed. It's a concern for lung cancer patients that they may be triaged and have treatment, and so we have to address those fears. Now that vaccinations are coming online, I would say back in the fall, as they were becoming available or as we knew they were coming, there were concerns about their safety, their risk and benefits of getting vaccinated, should cancer patients get one. I would say now we're seeing a transition into how do I get it, and I'll touch on that more in just a moment as well, but I think now we have to ask about the long-term implications of COVID-19 for patients with cancer. We know it's not just a mortality issue, it's also a survivorship issue, and there are going to be long-term issues for all patients who are COVID-19 survivors, but for cancer patients in particular, there's this looming question of how long will normal life be on hold. Patients with cancer often have important milestones that they want to accomplish, and there's this looming sense that they're missing out on those important milestones because of this pandemic, so that is another element of this that we have to address is the mental health implications for patients. Next slide. I would say also patient concerns vary by several different variables. During our rapid needs assessment survey, we found that concerns varied by age. For example, those under age 60 were concerned about impacts on lung cancer research and care, whereas those over age 60 were concerned about still being able to access their provider and fears about the technology challenges as everyone adapted to telehealth, for example. Geography is also important. Earlier during the pandemic, there were issues about patients living in a COVID hotspot versus not living in a COVID hotspot. Certainly now everywhere is a COVID hotspot, but that is an ongoing issue. The issues around urban versus rural setting, community versus academic center, and access to care facilities is important, and we must continue to address the digital divide. There are also patient-specific factors according to the diagnosis, stage of treatment, the type of therapy that patients are receiving, if it's chemotherapy versus immunotherapy or targeted agents. Next slide, please. Much of our recent advocacy work has been around the call to prioritize patients with cancer for vaccination against COVID-19. As part of the work that I'm doing together with Dr. Rolfo, we are part of a group called the COVID Lung Cancer Consortium, which is a global assembly of thought leaders in thoracic oncology, virology, immunology, vaccines, as well as patient advocacy, and we have representatives from NCI and the FDA. We issued a statement recently calling on CDC and other leaders to prioritize patients with cancer for vaccination. Since then, other leading oncology groups have also issued a similar call or statement, including ASCO, the American Cancer Society, AACR, ESMO, and CITSE. This is, I would say, a growing urgency for our community when lung cancer patients have mortality approaching 32%, yet we're seeing varying policies at the state level regarding where they fall in the priority list for vaccination. This is a big push that we're undertaking at the level of the advocacy groups to support our community. So patients can benefit from the advances occurring in the lung cancer research realm if COVID-19 gets them further. So this is something I'm very passionate about. So with that, I believe that's my last slide, and thank you for your time. Thank you, Amy. Thank you for a great talk, and we will remind everyone that they can enter the questions in the Q&A section. We don't have the raise hands possibility today, but you put there, and we will certainly take your questions. So we will open now the discussions, and I say this was a very difficult year for everyone. Like Antoniette said, this is a global problem, and we don't know when this pandemic will end. We know that now we have the vaccines, and we are very excited about that, but it's still a lot to do to go out from this pandemic. Certainly, we need action right now because unfortunately, research doesn't stop, and we cannot put on hold the research for our patients, even though we need to say that was a very exciting and terrific year for lung cancer because we have several approvals by FDA. That was a great job that the agency was doing to get all this access quickly for our patients, but we need to take some action. So during the pandemic, we were able to learn, like you say, there are several new tools or all tools that we revalorate now like telemedicine, and I would like to start with the first question to everyone, the impact of the telemedicine from your different point of view, and also the legal aspect of this telemedicine when we are talking about clinical trials. Just start, Antonietta or Jyoti, I want to hear your first, and then we'll go for the rest. Sure. So I'll start. My center, like many of yours, is one in which we have a 15-hospital network, and most of the clinical trials are happening in the downtown campus where I work. And so certainly, I think the telemedicine provided an opportunity for us to see patients and to think about clinical trials for patients in a wider network than we normally would have. And so patients that might have been living two hours away could be assessed and have a consultation, be screened for a clinical trial, and then really think about having access in a different way. So in terms of clinical trial accrual and access, I think that the advent of telemedicine very much has changed our availability for patients who are interested in clinical trials. The other side of that is certainly tough, right? The inherent problems with telemedicine, and Berkeley touched on this so nicely, the trust and relationship building, the fact that many of us care for our patients but very much think about our patients and their role in their families and how those dynamics changed. But one of the silver linings, I think, is absolutely the idea that our clinical trials become much more available to a greater number of people, but I'll let others comment. I think I'll agree with all of that. Telemedicine was very helpful. It's also very difficult for some of our patients. It's challenging with regard to, for some of them, some of them didn't have the ability to do it. So I think for us, it worked out fine. As I said, we had IT support in the clinic so that things went smoothly, but it's difficult. We were able to keep our clinical trials going. The majority of our trials, patients are accrued mostly in the hub, in the central area, but out in our satellites, of which we have many, we were still able to continue. And I think, as Jyoti said, because of telemedicine and off-site monitoring, I think that helped a great deal. We have clinical research associates assigned out to the satellites and they were able to continue to monitor safety and everything necessary to keep the clinical trial going by doing it remotely. So that really helped a great deal. That's a good point. We will go back to this monitoring off-site, but I would like to know from the point of view of Amy, patients, we were pointing that, that is something that we are facing. Depends on the geographical area that you are serving, we have different patients with different backgrounds and it's difficult for them even to have a call sometimes. It seems difficult to understand, but it's true. It's a normal situation that we have. How are the consequences for that? In terms of, you know, there is something that one patient told to me and I think was something that changed my vision a little bit because we were very worried about the patients, the clinical trials, the accomplishing the treatment, but there is an aspect that we were not really thinking about, that is the loneliness, the alone feeling that the patients are living in-house without the contacts of the team, the doctors, the nurse, the other, the advocacies in our hospital. What is your thought about that Amy? I mean, I think there are multiple things, you know, in terms of the digital divide, you know, we're seeing it not just in the cancer community, you know, we're seeing it in our educational system with, you know, when we don't have consistent Wi-Fi available, you know, in different parts of the country. So issues of access and in trying to ensure an equal playing field, I think that's one. Two, you know, we've heard about challenges of, you know, patients who maybe are experiencing issues with telehealth across state lines and reimbursement policies and all those kinds of issues and where physicians are, you know, accredited to deliver those services. I think that's something that we've encountered along the way. And then I think issues of social isolation and the psychosocial impacts of the pandemic, you know, are going to be felt for some time to come. You know, it's cancer is a very isolating and can be a lonely experience. I think one silver lining, you know, that I see in working with the different, I would say, oncogene driver groups is they have, you know, created a formidable presence online via social media. And I think that is something that allows patients to come together and share experiences and challenges and have that sense of community when maybe they can't be together in person. But, you know, yes, of course, that's an issue. And, you know, and even in patients who are cured or NAD who no longer, there's always that concern of the handoff of patients, you know, wanting that personal touch. And so how do we, you know, how can we recreate that in this ongoing pandemic? So I think there are multiple things that we have to continue to think about at the patient level. Yeah. And Katie, also for the e-consent that we was discussing there, Tony gave us some example of the tier 2 and 3, this kind of trial that we can start to use the e-consent, the electronic consent, or even the consent through the website in telemedicine, is something that is feasible? You believe that is something that we can apply this in the future? Because now this new reality or the new situation that we are living will be prolonged for a long time, I think so. So I have to say, we haven't had issues with signed consents. And I've asked the teams to bring this back to me in terms of, you know, how have we allowed sort of, so we've actually changed some of our protocol language to say informed consent discussions before it had to be, there was like, actually, it was different, it was signature. So I think we'll have to continue to modify our approach and thinking. So far, we've been able to get signed consents, which I think has been helpful. But again, looking to the future, we'll have to make these considerations. It's really important, as Berkeley pointed out before, that discussions are really well documented. That's another really necessary part of what we're doing. Yeah, that's true. And finally, Berkeley for the research team in general, I will speak now about only nurse navigators, but also monitoring and data managing and study coordinators was a very difficult year because we have some of them, they are working from home. Some of them are coming only some days to the hospital. And there was a lot of we was talking about the of monitoring. So it was very overwhelming for some of them because you have continuous Zoom calls like we have. But there we are speaking about the quality of the data. We are speaking about how to enter in time the data. And sometimes you have all the people at the same time. So how was your feeling during this year? I think that was one of the biggest challenges as research nurses. We wanted to provide the same level and quality of care to our patients as well as in our documentation. So that way, research was conducted at the same quality level, but also overcoming all of these barriers. And so a lot of ways we overcame that was making sure we were communicating with our principal investigators on a weekly basis and study coordinators and staying organized and making sure any new processes or workflow were communicated to patients and also making sure when we're utilizing those telehealth visits and we're talking to patients that everything is documented. And I think we were good with documentation and very detailed before, but I think even more so now we appreciate that. So that way, with all of these different remote work models, we're able to really know where the patient is at in their treatment and what's going on in regards to adverse events. So certainly that was something that was pretty challenging for nursing initially on top of just providing the basic comfort of oncology nursing and having patients overcome that lack of in-person, face-to-face smile or comfort. And how do we get innovative and provide that through a virtual platform? So, yes, certainly there were many, many challenges, but it has pushed us to become more innovative and provide quality care just in a different way. Yeah, I have here a question from the audience that say, hi, I'm an oncology fellow from the biggest cancer center in Brazil and a lot of recruitment in open clinical trials here were shut down. I wonder how the current situation for the recruitment of eligible patients, open clinical trials in U.S., worried about the possible data delay. But also, to be honest, this is something that we was worried about as well, because access to clinical trials sometimes in the tier one in patients that we can have a real benefit from that was very concerned for us. And we are not talking about only U.S. This is a worldwide organization and we need to figure out what is happening in other areas of the world. And actually, the pandemic is different and the waves of the pandemic is different in the different regions in the world. How we can cope in that? But, you know, I'll try to answer that to a point, you know, in Pittsburgh, in the first wave, we actually were quite fortunate in that we weren't a hotspot. We were we did have a lot of cases, but not like some areas. So I think that's one way we were able to continue the trials. I think that areas that are very that are hotspots, that are very that have a lot of cases and a lot of hospitalizations, it might be more difficult. There's no doubt about that. I think that now with the second wave here in Pittsburgh, it is much worse. And because of our of some of the things that we have, some of the things that we instituted from the first wave are helping us continue the research through the second wave. So I think that, you know, putting many of these things into play, you know, in some countries, I don't know how telemedicine is going to be used, but, you know, remote monitoring and can be put into place to try to continue these trials. It is difficult. It's a difficult situation. You know, we were talking about patients being reluctant to come in. We actually had a lot of patients who wanted to come in because they were afraid, you know, of their cancer getting worse and not being seen. You know, I you know, that that was another group. It was a big group, actually. And I think if we can ensure that the clinic is safe for them, in many of the ways I talked about, making sure that it's clean, that you social distance, that you screen people, I think they'll be more willing to come in. And for some of these maybe tier one trials where the in-person visit is much more important. I'd add a couple of other comments to that. Chicago, which has been pretty hard hit during the first wave, everyone was home, elective cases were canceled, but cancer clinics continued. And we were some of the few people that were in the hospital. So patients could come in, get their CT scans, actually get clinical trials without a busy hospital. And they felt very safe. The second wave has been much more difficult because all services continue to go. People who didn't get care for six months are in the hospital and were at capacity. So availability of scans, biopsies, just sort of managing flow in an 800 bed hospital has been significant. And so I think although we've learned so many lessons and so many mitigation efforts have been in place, this longer plateau has actually been much more difficult because we've all now got, we're up to speed, we're doing conferences, we're doing all of the work and trying to fit in our trial patients to hospitals that are already overburdened. So certainly I think these next months, I think we'll be sort of critical to see what deviations look like. It's just even scheduling has become much more difficult on our end. That's true, that's true. Christian, if I just might add from an industry perspective, I think it's been very important for us to keep our trials open. We have continued all our trials, we've ensured the supply, we've adapted to remote monitoring, things like that hopefully we'll keep in place. And it's been, and we're continuing to develop new trials so that way, as I said before, so that way we can get new treatments out to patients. One of the aspects we've seen is because of all of these issues that Tony and Jyoti have described and closures, we have seen some slowdown in enrollment, but that's universal. It's not just our trials. No, it was a terrific kind of joint efforts from the clinical part, from the clinicians and the companies as well to maintain this access for the patient. And even though with the team, so for example, in our institution, our team was very eager to get even the biopsies that are even not mandatory for clinical trials, but we know that this is giving an important insight for the understanding of the biology of some of the process. So it's important that we keep that and was a very, very important efforts that was done. I have some questions, several questions from the audience about the vaccination. One of the sentence that Amy say, and I saw that in Twitter a lot, that there is a lot of concern about the priority of vaccination in lung cancer community, in cancer patients, but we will say lung cancer specifically with the data that we know that the mortality is very high, why we are not vaccinating our patients quickly. And that is one of the concerns, but then what happened with this vaccine when we are going to enter patients in the clinical trial? There are some recommendations from that. There are some people in the companies that they are recommended a kind of time between the investigation and product delivery and the vaccine. There are some rules. We know that there are some rules now from different societies about the use of target therapies, immunotherapy and vaccination, but we don't know what happened with the clinical trials. Amy, some comments about that, and then Katie and Barkley. Sure. So I defer to Dr. Wozniak and Dr. Patel on the timing of vaccines and clinical trials that is not necessarily in my domain, where I come in from the advocacy perspective is at least trying to get the message out that our community is at risk and they should be vaccinated. I don't think patients have been asking, is there any reason they should not get vaccinated? In my understanding, and others can correct me if I'm wrong, is that we don't see any reason, at least with Pfizer and Moderna, that there are any universal contraindications. Now, there are caveats, and we still encourage patients to have a dialogue with their healthcare provider, but we are trying to be more visible. And ESMO recently had a call to action regarding vaccination of cancer patients. And within that space, those with hematological and lung cancer seem to be the most at risk. Now, as far as timing and how that works with clinical trials, I defer to my colleagues, but we just want to get the message out to patients that one, it's safe, two, we advise them to get vaccinated as soon as possible. And we're calling on leaders within CDC and other institutions as states make their policies to consider vaccinating cancer patients urgently, because we do know we've made great gains in the lung cancer space, and patients are living years with good quality of life. And so it's important that they have the opportunity in as timely a manner as possible. I think we don't know a lot about the vaccine. The trials didn't include patients on active chemotherapy. So we don't know. However, I think, this is just my personal opinion, it's maybe not scientific, but I think that probably all cancer patients should get it. Personally, okay? It's, again, I can't go by the evidence, but I think I feel it's like getting a flu shot every year, you know, and we give it to all our patients, who will take it. In terms of the rollout of the vaccine in the United States hasn't been fantastic. And it's state by state. And I just went to a update about what our next group is. We've done pretty much all our health workers. And the next group actually is going to be the elderly. That's the way they're going. It was actually 75 plus, now it's 65 plus. That's what they're considering. And it really, it can be cancer patients or not. So they're not given a priority based on whether you have cancer or aren't in treatment. Actually, it's whether, how old you are. So I have a feeling that may change. Yeah. One more thing to add to it. I think these are great points. Like certainly, I think it's a data-free zone, but if we extrapolate from what we know about flu vaccine, it makes good sense. From a trial perspective, from a research perspective, and then just a clinical care perspective, I think oncologists are highly vested in getting our patients vaccinated. When a patient is COVID positive and we need to deliver therapy, it becomes quite difficult. I mean, we all have negative pressure rooms, but those rooms are tough to get. We're booking them out three weeks in advance to get patients safely to treatment that need treatment. But for an already overburdened system, as we all know is happening across the country and other parts of the world, this adds sort of another layer. And so we feel that sort of securing our infusion centers in many ways, making them safe is an added benefit to all healthcare delivery. Katie, any comments about the clinical trials on vaccines? So I said in one of my first slides, I encourage investigators to maintain steady conduct, but then assess the risks and benefits for each patient. So I think that this is a risk benefit discussion. Some trials have language in there that pertains to vaccines. They're mostly live vaccines and live or live attenuated or replicating vaccines for patients that are immunosuppressed. So chemotherapy, radiation therapy, and that's because of this risk of prolonged shedding or developing that disease in the individual. So I think that ASMO, CIDSE, and ASCO all came out with statements that cancer patients should be vaccinated. So, and the approved or emergency use vaccines are not live, right? So both the Moderna and Pfizer are mRNA vaccines, at least in the United States. So I think that that's something that you need to risk benefit discussion and make sure that, so again, the live vaccines are generally the ones that are excluded in protocols. So we think that patients should also be vaccinated. Yeah, and Berkeley, any comments about that, about the patient's concerns? You know, in building on that, I think, we encourage all of our patients to get the vaccine and as they gain access to it, we do communicate with the study teams to make sure there's no concerns, but obviously the priority is getting vaccinated as soon as possible. And a lot of study teams are giving guidance and sending through amendments, you know, giving us guidance on if there's a particular timing, but essentially most trials are being very understanding and flexible with how patients gain access to that. And so certainly it's very important to keeping all of our staff and patients safe. So yes, we're certainly recommending it for all patients, but still trying to make sure that we're being safe especially for clinical trial patients. Yeah, and now we have more and more, yesterday, for example, the new data from the Johnson vaccine is coming out. So we will have more vaccine in the landscape and we need to obviously adequate that according, you say, Katie, about the Moderna and the Pfizer that we know they are RNA, but the other ones that are coming, even the several companies in the world are working about that. So we will have different kinds of vaccines and we will be able to adapt that in the clinical trials in the clinical practice as well. Joy, you was mentioned about the basic research and certainly it was a very difficult year because in the beginning we have communications from the dean office that they say only COVID research can go at the moment. And then we have difficult to have even supplies and then funding was more allocated to COVID. How was the communication? Because the communication between the clinicians and the basic, we tried to bridge that, but it was very difficult year. It was a really tough year. I think a huge existential crisis for so many people of when will my research career get back on track? At our institution, we had a number of town halls from OSR and from the dean of research, really understanding how we were gonna support particularly these more junior investigators during the sort of rough patch. It has been, I think, again, sort of a pivot, this idea of, okay, what can get done during a pandemic? So a lot of data analysis happened. I got an email during this webinar saying that our funding, our NIH funding, actually at our university went up. People went home and wrote, right? And so I think there is that piece. Another silver lining I'm gonna say is that we had time to sort of clean up internal processes like office of sponsored research, get IRB and work a little bit on best practices to again, streamline some of our institutions. But I think the collateral damage in the basic lab is going to go on for years, right? We are going to lose a significant number of people who have said, wow, this is hard. As we know, if you wanna be a basic researcher, you really need to think about the long game and those immediate hits are tough. And so if you see people leaving the field, if you see people pivoting, it's really hard to see how you may have a career that is fruitful in 10 years. And the piece of it is, there's been some really great science, there's been more collaboration, we're sharing more than ever, but it is, I think, essential that we continue to communicate with our basic researchers, really involve them in sort of the clinical gains. And so that bridge, that translational bridge from bench to bedside continues to grow. It's true. And from there, Katie, the pharma is also helping with the research that they have. So it's something that we can maybe put some coins more in the collaboration between the academia and the pharma in this time, because it's really essential. Yeah, we're continuing to also encourage sponsor, sorry, investigator-initiated trials and encourage that continue. That was also important during this time. So we have here some questions that say, can you discuss a little bit more the effects of COVID in cancer care teams and strategies that you implemented in your place to strengthen the team-based care? I think some of the strategies that we was doing was that dividing the teams and go in some days for a team or another, but every center was applying different recipes. What was your recipe, your sentence, Tony? You talk about that, obviously. Yeah, we actually, I think it's going to vary from center to center, okay? It's gonna depend upon the space you have and the number of employees. And we actually have, as I said, a huge group, over 200. And we had to really be forward thinking about how to manage their presence here. And we did. They had staggered shifts. Some days they worked from home, some days they came in, but we just had to make sure that when they did come in that they could properly socially distance. So a lot depends, as I said, on your institution, how many employees you have and what you can do. Certainly the ability to do Teams meetings and Zoom meetings really helped a lot in terms of coordinating things. So it has to be institution by institution in terms of what kind of rules you set up. And then you have to monitor your personnel in terms of their contacts. We did that as well. We were prepared if someone needed to quarantine at home because of an exposure. So again, these are all rules and things that you have to set forward. And we need to do this probably for quite some time until this settles down. And who knows what's going to happen in a year if this settles down. Is it going to be like the flu where it returns every year? So we have to be prepared for things like this. And I actually think that some of the things can be cost-saving, the remote monitoring. And so maybe this is the wave of the future permanently. Yeah, I think I learned lessons that we have for this historical outbreak that we will continue to keep. And that's the positive side from this terrible situation. I have a last question because we have unfortunately limited time. I have here a question that say, give me one second. There is any psychological support because when you was speaking about a lot of clinical support, clinical research but there is any psychological support for patients and caregiver that were implemented by the advocacy and the clinical or the institutions they say here? So Amy. Sure, I mean, certainly that's a big component of what GoTo Foundation for Lung Cancer does, what our sister organizations do in longevity and not just the research side but the patient education and support side. So we have a dedicated helpline as do our sister organizations. And it very much has been kind of all hands on deck to provide that level of support. Patients have multifaceted concerns throughout the pandemic. And so we want to be there as a resource, as a support to them. I do think part of the reason we conducted that rapid needs assessment survey back in June was to really understand the complexity and breadth of patient and caregiver concerns so that we could begin to adapt our programming to provide the level of care and support that they need. So I think that's something that we'll be looking at going forward, recognizing the challenges that we're all facing, financial bandwidth, but there's this commitment to our community because this is an unprecedented convergence and it really is a huge challenge for the lung cancer community with COVID-19. So I think we're all very passionate about doing whatever we can to support and navigate our patients and caregivers through it. Yeah, and Berkeley, from the point of view of the institutions, how you was handling that? Certainly, I think as nurses, one of the most important things was making sure our patients had all of the resources they need for that psychological support because already as a cancer patient, there's anxiety, there's depression and not being able to see your family and just have that hug or that warm embrace, it's challenging. And so as nurses, we're really trying to utilize palliative care, symptom management, as well as psych oncology support. And the nice thing is that telehealth has allowed patients to be in the comfort of their home to do those visits where it might actually provide a more comforting environment than coming to the hospital, which is one positive thing. And so definitely making sure patients know about those resources, understand how to use them and empowering them to use them. Guys, I will be here for hours talking about that because it was a very great discussion. But unfortunately, that is all the time that we have today. I would like to thank, first of all, all the speakers, the participants and ILCC, especially to Aubrey and Kristen for the support that they provide for this webinar. I remind that you will receive an email today, all the participants. So keep an eye on this email for claiming your CME credit. And I hope that you are safe and we continue to deliver the care that we want our patients to receive and is the high priority. Thank you very much for your participation today and have a great day.

COVID-19 pandemic

clinical and translational research

cancer care

healthcare professionals

researchers

patients

strategies

telemedicine

remote patient care

clinical trials

patient and staff safety

trial protocols