Hello everyone and welcome to our webinar, Finding the right dose using patient-reported data from early-phase clinical trials. And we are pleased to have you join us today for this very interesting and exciting dialogue. Well, so that you can use the interpretation functions through Zoom, we are showing you on the screen the world icon that you have to select. There you press the button, select your language and then select mute or mute the original audio. So, we are going to give you the user guide through the chat of the languages that are currently available for simultaneous interpretation. If you have any problems, please let us know. And well, we would like to thank all our participants and our allies for sponsoring this event. Here the objective of this ISLAP Starts program is to be the ones who have the impact and defense of patients who have lung cancer and to be able to get involved. We are trying to educate about the science of lung cancer and the research that is done and an effective model for communicating the science. and research and find new opportunities. Some notes for the procedure of our meeting. Please use the question and answer function, includes the end of the session. We will be answering these questions. We will also be in the chat giving you the list of terms, as well as the guide or manual for the use of interpretation of the different languages. This webinar is being recorded and will be available at a later date according to the assigned languages. Here we have the different moderators that are going to help us share your experience. We have Dr. Belinda King-Calamannis, who is the director of research focused on patient at Lungabity and doing work with the FDA at the Cancer Center of Excellence. And here we also have Ann Loesser. She was diagnosed with cancer at the age of 39 and, as a patient advocate, is the lead of the graduate project and establishes the dosing initiative, PCDI, advocating for patients and oncologists and promoting dialogue to provide support and select the optimal dose for the patient. We have Lee Jones, who is a long-time cancer survivor and is doing advocacy for research proposals. He speaks at conferences, writes papers and we also have Janice Cowden on the Q&A session. So, she was the one who was diagnosed with class cancer. 4 and she is on the patient-centered dosing initiative starting in 2021. And we also have Janet Freeman-Dailey, who is a long-time patient and is also on the administrative team. All of these experts bring different perspectives to our today's dialogue and they are going to give us an understanding of what the optimal dosage is. So, we give the words to our panel of experts. Allow me a second, I think I'm not sharing correctly. Here we go. Thank you very much, Sarah, for your kind introduction and well, thank you for being here on this program and for inviting me to speak with you here today. Im going to to give a general overview, starting with how we can diffuse with medications traditionally determined, the dosage of anticancer drugs during first trials. We're going to look at the different therapies and we're going to be talking about the potential impact that patients can have on finding the right dosage. In these discussions, we are talking about the patient-centered dosing initiative and we are going to hear from Lee, Ann and Janice Condit. They are the ones who have done great progress and they have had talks. And we're going to have Janice, who's going to be doing the facilitation. Here we will be sharing with you the important terms, they will always be available for reference because we have specific terminology, but I want to focus on some of them so that you know, you get to know them in the talk on the day of today. This is limited toxicity according to dosage. Here you have to see how increase dosage at the time an evaluation is made and defined according to the trial clinical that is being carried out according to the protocol. We have the maximum tolerated dose, which is the one that will give us the desired effect without any side effects. unacceptable. All of this is covered by legislation and refers to any type of data that is collected by anyone, sharing experiences about the disease and that can have a great impact for the disease, the therapy, but it also has to be around preferences of the patient regarding treatment. Now, patient data is what we call results reported by patients. These are questions that are asked directly to patients about the treatment, the dosage, and all of this is answered before the clinical. But before looking at the dosage, I want to show you, those who don't know our development, this here on the left side. We have what happens before us Let's get to the test. This is where we really have the understanding about the drug, Tests are carried out according to the security involved. Here we have reached the safety phase of that clinical trial, when it is introduced to people, and then we have passed through phase 2, 2B, and we arrive at phase 3. Here this takes us to clinical care and in some Sometimes we also have phase 4, which here are activities that ensure that that drug be really effective. Today we are going to concentrate on phase number 1 and the beginning of the Phase 2. Here we have the traditional dosing paradigms for anti-inflammatory drugs. cancer. Here, first of all, all these case studies are predefined before they are do clinical tests. So, here at the bottom we have three little green dots that They represent three people who will be in this study. Here we have the timeline and On the other hand we have the dosage. So, those three people who are in the lower, we can see that no one reaches a dose that has toxicity. Here we we see the protection that is being provided. So, here we are going through nothing toxicity until now and then we are controlling the side effects that they can have. When they have them, they can be of different levels, some bass, some medium and some normal. So, here we already say, this is 50 milligrams of dosage. Now we have 50 milligrams of dosage in three people, but one is experiencing toxicity. So, what happens is that three more people are also going to put themselves under a dosage of 50 milligrams. Now, here none of these three new ones who just entered It has those toxicity effects. So, well, now we observe that we have two people who are experiencing that toxicity. So here we have to go back to check the dosage. So, let's look at the recommendation about the dosage for the next clinical study. Now, as we put it on the right side, according to the image that have on your screen, then it can be interpreted in some way. Normally, all of this is circulate until one reaches this phase that you see down here and that we have the maximum dose tolerated. While we are thinking about the change in dosing paradigms, We have to describe exactly that dosage, maximum tolerated dose. The day of Today we are looking at the studies and we have target-molecular therapies. And then here We are seeing that the maximum tolerated dose can reach a degree where when We started phase 3, we are not having the greatest success within that clinical outbreak. So, We are looking at therapies that are applied for longer periods. And then, Here there can be six cycles depending on the treatments to which they are subjected. But here We are seeing that people who suffer from lung cancer are beginning to get worse. Here, then, there is a concern on the part of the United States FDA. We are told that we we have to have moderate dosing findings. And here, then, we have We have to see what side adverse effects are tolerable. And so we have to see the opportunity they can benefit from when doses are reduced. Then we We are seeing that we have a persistence according to the side effects. So here we see the different options for patients for the next treatment and the doses to be applied. Here I also wanted to give you a general overview of what we have seen in the last decades. So, here, at the end of the eighties, we had the entrance to Sidobudin market. So, in this paper that was about the conclusive findings of HIV with a dosage of 300 milligrams, we are also finding that they had effects similar to higher doses that were 600 to 1,500 milligrams. So here, He decided to see that perhaps lower doses could be used. So, here we are already in the year 2002. And then, we are seeing the different co-actors and the FDA that published a paper to see what changes in dosages could be made to the drugs and that could be approved. So, people have been doing research in this regard. In 2015, The Japan Drug Manufacturers Association, which is a regulator, then published a guide which includes dosage considerations in the Japanese population. In 2019, we had the patient-centered dosing initiative. It was created, and in a few more moments about it, and then here we have the Canadian Drug Agency, which also published A guide to dosing and timing of cancer drugs in immunotherapy. So, here in 2001, we see the optimization projects that the FDA introduced. And then, in 2022, we are seeing how cancer drugs are established, the Cancer Drugs Forum, to optimize cancer treatments in practice. And now I am going to talk to you more specifically about the Ecological Center of Excellence of the FDA, which launched its Optimus project. So, here we have the objective of educating the patients because sometimes it is part of the paradigm. So, we have to guarantee the safety of the patient who are having a tolerance to the therapy. Then we We have the objective of achieving another, issuing the documents and guidelines, guidelines necessary. And well, we will have a final version when it is already in development. Also We want to organize workshops, public meetings and provide opportunities to speak of dosing optimization with all drug developers. So here we have to consider the different dosage ranges according to the clinical data and non-clinical in the new strategies. So, we, for example, 32. So, let's see the dosage range being used and in its upcoming clinical studies. So, There are a couple of aspects that I would like to highlight according to the guidance that has been published by the FDA this year. So, we are talking about a maximum tolerated dose. Here we see that there are dosages that are not adequately tolerated. So, this has to do with how the person feels and the quality of life they can lead here, for example, in people who remain in treatment. And we have dialogues about accession of patients to treatments. As I mentioned, we have the results reported by the patients that I mentioned at the beginning. It is a systematic way in which we can collect information about the symptomatic side effects that may be used later to understand how the patient tolerates the new treatment. And then we have the active participation of the patient. People like you and advocacy groups defense that they are talking about all the drug safety and tolerability considerations. So here the FDA has stepped up some concepts that are very important for all this. Here we are talking about the side effects of different dosages. And so, we have a list of questions. In many libraries we are seeing the different types of side effects that can be had. AND We have developed a program and we have selected it that has to do with a treatment specific. The questions we ask are going to have to be either from the set of core questions generated by the National Cancer Institute or some others. And here we have the physical operation. Here we All this has to do with the effect of the drug. Concepts that are extremely interesting. Regulators are always interested in having close monitoring according to the functioning of the drug. So, questions are going to be asked to see what, how do you feel. And, well, we have an example of some of the questions. Here we are seeing that if they have a physical fusion with difficulty, without difficulty and all those kinds of questions. Here we are seeing that they have to be personalized according to the environment in which we are working. So here we will depend on how We keep the history of said disease, the differences, the degrees of lung cancer and, well, determine what is the best treatment. If the patient already has a treatment that is working well for him. So how can we use the results data that report the patients? Well, they are the experts. Here we can see the data related to fatigue, reported in months, if you look. And here on the X axis, the incidence. And we can see that the Clinicians are not reporting what patients report. The clinicians' report is that of Gray. But fatigue and nausea are difficult effects to observe and that is why we see these. AND This offers an even better analysis of side effects, which are a series of sets of side effects that everyone participating in the clinical trial has had. had. They are simply asked because they might forget if this effect was resolved. We have less serious effects and knowing that they are going to have effects, they will be able to handle this better. For example, in phase 2, many patients had diarrhea that did not occur in the first months and it may be good to introduce the use of antidiarrheal medicines around the fourth month to prevent diarrhea from being a side effect in the fifth or sixth month. This is an important consideration in relation to the answers or challenges of having the symptoms reported by patients. So, we have the reports from the clinicians, we have common comments of events, for example, diarrhea, grade 1 is a less serious event and grade 5 is when, at worst and unfortunately, it ends in death. Now, here we have the option of questions for the patient and if we see these different categories and if we can match them with the grades, grade 2 is a moderate increase in toxicity and this is an increase from 4 to 6 diarrheal episodes during the day, but I think That in this category of frequent or almost constant would be what patients would report. So, We are not surprised that these are going to be matching based on this score. And the FDA has recognized this and it has been updated that sometimes the reports from patients and clinicians do not coincide and you can, if that is the case that you find, you can refer to this document. So what role can you play in these discussions? It is important that interest groups such as regulators, payers or those involved in protocols are educated in the value and approach of including the patient experience and data in dosing studies. Get involved in these groups organized by societies professionals, government groups and also patient advocacy groups. They can also enroll in an institutional review board. In the United States it would be the Department of Human Services and with the FDA. There is always a lay person on these committees. The universities They have these committees with the WGC and here is a link, a web page where you can see more information about this in a YouTube video. And with this I give the floor to Sara to continue with the next presentation. Thank you so much. Very well thank you. Welcome. I'm Ann Luscher and on behalf of the Dosing Initiative Patient Centered, I would like to thank the IASL for their invitation to present this summary of our work along with our main lessons. By way of background, The PCDI was launched for people with metastatic breast cancer or MBC four years ago. He The purpose was to mitigate the prevalence and severity of side effects related to the treatment of patients. We quickly formed an Advisory Council of Oncologists Mexico to ensure that everything we did was medically and ethically sound. We perform investigations into the main cause of treatment-related toxicity and We determined that the maximum tolerated dose or MTD should primarily be used as the dose of recommended initiation or RSD in oncology medications. We also find studies in the that lower doses of some medications were as effective as the MTD and generated less toxicity. The conclusion was two answers. Yes it is possible to change the paradigm the more MTD the better. We also wanted to encourage discussions between doctors and patients after of treatment regarding the best dose for the patient based on unique characteristics. We conducted two surveys. It was originally a survey for patients with MVC and after one year Next we distributed a survey to medical oncologists who treated patients with MVC. The Objectives of both surveys were identical. We wanted to understand the prevalence and severity of treatment-related side effects in patients with MVC. we wanted Find out the level of communication between doctor and patient about side effects. Also we needed to discover the impact of lower doses on patient outcomes in regarding quality of life and efficacy and finally determine the willingness of patients and doctors to discuss flexible dosing options together based on the characteristics patient's personal Basically we wanted to find out if we were going in the right direction. We received 1,221 responses from patients and 2,119 responses from oncologists. The responses of the The oncologists' survey is in gold font and the survey results are in white font. The majority of patients, 86%, indicated that they experienced at least one secondary defect related to treatment. Most of the oncologists' responses underestimated that in less than 60%. One in five patients with side effects had to visit the hospital emergency room. As a result, the oncologists' estimate was lower, by 15%. More than two out of five patients had to issue a treatment and the estimate of oncologists it was 37%. Almost all patients, 98%, told their doctors about the side effects. 71% of doctors indicated that patients They felt better with a lower dose and that the efficacy was similar to RSV. They also We asked both if they would be willing to discuss flexible dosing options between yes and 85% of oncologists disagree with this more MTD is better paradigm. Finally, We asked them both if they would be willing to discuss flexible options based on the attributes of the patients, and more than 90% of both groups indicated that they would be willing To do it. Therefore, these results corroborated our mission. It was determined that there is considerable prevalence and severity of these side effects. Most of the patients with side effects, told their doctors, felt better with a dose lower and most patients and doctors would be willing to talk to each other about Flexible dosing options depending on characteristics. It's one thing to conduct surveys. and another is to do something with the results, so in 2021 we had the privilege of presenting a presentation of the results of this survey at the American Society of Clinical Oncology. Since that time, we have presented posters of our results and published them in magazines. peer review. Five months after our oral presentation at ASCO, the FDI announced the next. It is clear and strong from our patients that medications are too much. Patients deserve a more tolerable dose and that sounded like music to our ears. I want to draw your attention to the fact that there is a migration away from the more-is paradigm. best of the MTD regarding experimental drugs, especially phase 1. The FDA's Optimus project is ahead of the industry to evaluate at least two doses in based on its efficacy and tolerability instead of automatically selecting the maximum tolerated dose. In relation to the drugs approved on the market, the Renewal project The FDA is reviewing the dosages of certain approved cancer drugs. He oral drug Solote is the first drug to receive a related label update with dosage and in the clinic the PCDI continues to encourage discussions between doctors and patients. These will continue to be important because currently approved drugs They will continue to be prescribed mainly in a traditional way based on the BAT. It will take time so that drug development makes the new paradigm of the Optimus project a reality. The responses of patients in the real world may differ from those of participants in clinical trials. As for the main lessons of how to demand change, we have learned On the path where you can involve patients and professionals, you have to incorporate them to the team whenever possible. We must evaluate the concepts for resolution, ensure that all team members recognize that the only bad idea is the one that do not say. A mission and a plan must be collaboratively developed with strategies to try them and carry them out. The data really speaks. Every time it is possible it must be done studies and when we have confounding factors like artificial intelligence where you can do this, evaluate the results against your mission and present them, publish them if necessary, reevaluate and readjust. The path to success seems simple but it involves a lot of work, requires motivation, skills and perseverance. And finally I want to share some key lessons from the studies. The first is to avoid open questions in which the recipient has to fill in the blanks. This involves cleaning considerable data and some quantification problems. After developing the questions from your survey, pilot the survey to get feedback from a diverse group of possible recipients. Involve the institutional review board before launching your study because it will give it credibility. Broadcast a speed graph response throughout the study to discover if you need to do additional advertising to attract to more participants. Our velocity graph is blank and at a lower point we create this infographic on the right to encourage more participation. And finally spread the information present and publish your results whenever you can, both informally and professionally. And last but not least, I want to thank you for your kind attention. Fantastic. And now let's listen to Lee Jones. Yes, thank you very much, Sara. Thanks to the IASLC for inviting me to speak at this webinar because these are key factors in my life and it always encourages me to talk about my experiences and encourage other advocates to become more active in the IASLC space because we know that as patients we can use all the help we can receive. I have two conflicts of interest. I have an offset for VER and GENMAP. This is a example that I am compensated for this defense work and it is something fantastic. Today I want to address the topic of this webinar by highlighting how I got involved in this, in providing context for how we can use advocacy work in similar ways, finding, looking for opportunities. First, a good start was joining STAR on a program about 10 years ago. We spent two and a half days there talking with oncologists, gastrointestinal, surgeons, trying to find out everything we could with colon cancer. It's amazing the little we knew at that time, but the restriction began and even more surprising because there was more and more knowledge about lung cancer and it seemed like an opportunity to me interesting. Something obvious about that training is that we didn't have a plan for how to continue. This is difficult for some people because we all tend to follow our own interest and the first thing I decided to do was talk to people at the Local Cancer Institute, where I received my treatments and I began to get involved in the RAB of Oncology. And this was already mentioned by the two speakers before me, but the good thing about being in this IARB is that You can be participating in the protocols, you can participate in informing patients, it is participating in the world of cancer research, but you acquire skills because you can understand the cancer research process. What is a good protocol? What is not good? And more importantly, what is a good way to consent? For many of us it is difficult to read with all these pages and words, We need the help of a doctor to understand, but I was presented with the opportunity to help correct these and made quite a few suggestions that were already incorporated into our feedback for the sponsors of this trial. That seemed very important to me. In 2018 he invited me ASCO to be an advocacy member on an expert panel working on the ASCO guidelines for stage 3 colon cancer patients. This was for a protocol for stage 3 patients of colon cancer, three months of isoplatin as effective as six months with the same drug, but with much less toxicity. This was of great interest to me because I received this drug in my treatment. Of course I was a stage 4 patient, I didn't have the luxury of being able to decrease the dose, but I said, how many people have we poisoned for so many years? Let's say, for 20 years we have poisoned them unnecessarily because for three months they suffered, I believe, one of the most terrible side effects that is neuropathy. And in reality they were never asked question, much less the process. Later that same year, I was invited by the Friends of Cancer Research, is an institution that I want you to remember because you are involved many. I was invited to review tolerability in cancer protocols. This tolerability It was a clinical definition because it was like it said, if the doctor tells you if you tolerate it, it is because you tolerate it. It was measured with biometry, liver analysis, but in reality it was not I never asked the patient, sir, madam, how are you feeling? So as a representative of the patients in this group, I brought up this concept. I said, why don't we include the patient perspective to see what the tolerability is? The patient has rights and You also have the right to say, I don't want this medicine anymore. I just wanted to get to this point, to the final definition. It really was a significant change. So the tolerability of a drug is when we have advances in administration that affect the ability or patient's desire to remain adherent to treatment. Tolerability has to be directly measured by the patient, how they feel and how they function. So that's one direct measure that has helped us achieve results. Actually, this tolerability included in the study has been a great opportunity for other defenders or activists. So, You can find the white paper. They have videos available of many of the sessions that have celebrated. We have also started Friends Advisory Advocates. It also provides opportunities. Member of these multidisciplinary expert panels, multidisciplinary groups that involve the participation of FDA, companies, investigations, institutions. Really a large number of experts that can sometimes seem intimidating, but as You may have already heard it, we are also experts because we know things that they do not know. So, the important thing about these panels when they talk about tolerability is that they say We want to see how we have to recognize the patient's perspective in that measurement of tolerability. In that meeting we saw that we could have a better understanding. We were spoken to and I I spoke about the perspective of tolerability and together I think we gave a very good approach. through tolerability. There is also a group called Pros to Inform Tolerability. Obviously, it was a study that is also being measured through patients and they are phase 1, phase 2 clinical trials. This is something that had not been done in the past. There is Phase 3, the determination, they said that it was viable, that it could be a good thing, because they can also take us to what began in April 2023. To examine phase 3 clinical trials, taking into account patient opinion, We realized that clinical trials are based on chemotherapy data. The medicine, which is the drug that is given to the patient, can also generate side effects and even within the world of chemotherapy, we have to see what the limit is and then, passing that limit, we will see that the toxicity is greater. So, maybe one doesn't want to extend to the highest. So, codynamics and the effective measurement that are done makes things more difficult in this whole world of chemotherapy. So, We were referring to the effective dose. I think we are still very far behind in achieving it, but we are moving forward and that is good. In fact, I've been thinking that we would have to have an entire clinical trial process from scratch to be able to test different drugs that we currently have and go little by little so that all this is applied better to these new generation drugs. The processes with chemo, one for the target or meta and good therapies, depending on the type of drug we are talking about. And here I will leave my presentation so that we have a few moments to answer your questions. Thank you so much by your attention. Thanks for your presentation, Lee. So, let's move on to the question and answer section. Here we are going to make available all these links that you told us about Read. Yes of course. So, Sara, I think Sara is including in the chat the links that Lee mentioned to us. Well, Janice, briefly, do you want to talk to us about your experience on this topic? Yes, here I am. Excuse me. I could rephrase the question briefly. Can you tell us how you got involved in this so our audience knows how you got here. In my involvement with PCDI, I have always been a militant patient advocate for seven years. So, I've known them for some time now. I was very interested in the research that he did from the beginning. So we started sharing the polls, especially in metastatic breast cancer Facebook groups. Essentially, my initial role was help disseminate these surveys so that patients participate. In 2021, I already joined as a member of the CDA. Well, we have several questions that are coming to us through the QIA function. We will not be able to respond to all of them, but we will do our best to respond. most of them. What is people's understanding of the reported data? by the patient or the results reported by the patient? In relation is that we have nothing with what to compare it. Well, we don't have anything either on the other side of the clinical data to compare. So let's say we go to the subjective side of things, but we also have to look at the objective aspects. We have the laboratory reports that give us subjectivity. So, In all this, of course it is not perfect, but on some occasions we deal with the results of the patient because they are being… if you are collecting data with a group for a treatment, well, everything is going to be weighted under the same considerations. We are thinking about the early phase, But I think someone else can give us more information. Esli. Yes, we must clearly define what to expect in terms of side effects that is easier to tolerate. the expected. Not, for example, having neuropathy, that you can't hold your hand if you want to open the refrigerator. If I knew what was going to happen to me, my hand would still burn, but I wouldn't be terrified thinking that something very serious was happening. So in other words, if you know what wait, maybe you can slow it down. I don't know if you're going to have diarrhea or vomiting, that kind of thing, but if you can lessen the effect, then it would just help a lot. Not knowing, I believe that one of the factors is the late side effects. You are in treatment, the treatment ends and three months later you have the side effect, you are already in another medicine. So it is very difficult to link this side effect with a medicine you took a long time because patients often have no idea that there may be a delay in establishment of side effects. Yes, there are treatments whose side effects are years later. Maybe your general practitioner has no idea what treatment you had right and can't know if it is a side effect of a drug you took some time ago and what to do Lots of back research to find out. Thank you. There is another question. When you are in a phase 1 clinical protocol, they may be evaluating multiple doses in these cases to avoid delay in approval. What a good question. I think we don't have enough information on this. The optimization strategy is pushing for this dose range in the studies. Normally phase 2 in the protocols is based on the different doses and their tolerability Maybe this way we can have information, additional security data and I don't know if this it may delay something. Maybe so, but this is being debated. But if you start the phase 3 protocol with a non-optimal dose, then you would delay the entire process. So I say, if there is a small delay, this would be offset against the risk of starting phase 3 with a totally wrong dose. Maybe, I don't know. Well, I think we should see the timeline for development. The part of this entire multi-year timeline, phase 1 It is really very short and I believe that this delay perhaps does not affect the total time it takes for the approval of a treatment. Very good, now a separate topic is mainly being talked about of this dosing strategy in phase 1 when you are trying to identify the dose more effective. Is this strategy different in phase 2? You were muted, sorry. Well yes. I think it depends, there are some variations. This is evolving even now, so that understanding the foundations is good, understanding what is normally done. We have opportunities to make decisions to change doses in the phase 2 and phase 3 protocols. This is defined In the protocol, there are tables in which the strategies will be used in the research of therapy in phase 3 comparing what clinical practice will be like. This does not mean that no aspects will arise and it will be discussed whether the protocol needs to be changed. And here it's like, I don't know, I think this is the answer I have for your question, I hope it is enough. Yes, thanks. And another separate topic. What is the, what has determined this strategy dosage? How is dosing information communicated to oncologists? What happens if they want to vary it and don't adhere to the protocol? Yes, we have already mentioned it, It is something very complicated. Basically, I should say, we don't regulate medical practice, we just look at safety. And since a patient is in clinical care, Of course they can pass, there is phase 4 and this may involve what you are saying, Maybe a change in the endorsement, I don't know if this has an influence, but maybe they change the evaluation of the treatments or there are also aspects that can be discussed on a channel with FDA regarding liability and there may be changes and there may be information in the label, but there is always information in the study protocol. This is where it gets complicated. thing because we have cooperative groups that use this information, they are participants also the protocols. This was implemented in HIV drug studies. Has this been tested, the changes? Yes. On a chemotherapy drug, the oncologists at the PCDI shared with our group that many oncologists, prior to the label update, were not prescribing the full dose to patients as they had observed too much toxicity, they didn't follow the dosage on the label, so we were very pleased that the Center for Oncology of Excellence changed the label recommendation. We have a couple of minutes left, I want to give each of you a minute in case you have some closing words. Janice, You haven't talked much, do you want to say something? Thanks, Janet. Well, I think that workshops like These are incredibly important because we are not only educating other patients and advocates patients, also to clinical doctors and we are reinforcing the importance of personalized medicine and also the optimal dose for patients because whether for cancer patients Mom, the treatment is a marathon, it is not a sprint and there are late side effects or cumulative that can have a negative impact on the quality of life of patients, then You have to be informed, perhaps patients require longer treatments and in exchange From that they will have more life with a better quality of life. Very well, of course, I believe that cancer patients They are a good target in this regard. Ann, yes, I think something we should remember is that each of us We are a unique person, we have variations from so many factors including our personal ideas and even with all these initiatives from the FDA and other organizations, We believe it is extremely important for patients and doctors to consider a patient's physical characteristics, body mass index, and also goals. of this patient and together determine the best drug for the patient and also in clinical protocols, patients are subject to very strict criteria for inclusion or exclusion but not in the real world, so answers may vary in the world from outside to those observed and this is even more worrying for the outcome of the patients. Sure, Lee, I mean we have to remember that we are the experts of our own diseases and we can understand well the process of developing a treatment, we will be very effective and We help researchers develop drugs that improve our outcomes and also those of people who have the same diseases. Thank you and Linda. I don't know that there is much to add, the panelists have decided but I agree than working with Lee, I just met Janice but I'm going to hope to work with her, I've worked with Lee and Janice too and it's been fantastic to work with them. Has been wonderful to see how they enhance the skills of researchers, learn about their experiences and You know that my door is always open to hear your ideas and comments. Well, thank you very much to all the participants for explaining how the dosage works but also for presenting patient presence and participation and how patient advocates can assist in this participation. Thanks to all who participated in the webinar and have a good night. See you later.

Finding the right dose

Patient-reported data

Early-phase clinical trials

Cancer treatments

Patient-centered dosing initiative

Metastatic breast cancer

Treatment-related side effects

Surveys

Flexible dosing options

FDA's efforts