Chordoma Clinical Trial Survey Results

How current connects in the lab to the basic science, the inflational science in the lab, the patient to the research. I know a number of comments about regulatory considerations and today if a company doesn't have the path to bringing a drug forward into clinical development ultimately potentially for that to best into the trial So working with regulators to understand exactly what level of evidence and types of data we need to cable on a vegetable approval is really, really key. And problem is it's never been done for never been drug easy for approved. It's no easy precedent just to follow. Um, not a lot of other precedents at all prepared answer either. So figuring out, exactly the regulatory portal that has to be over. Not easy, but it's really important to wear confidence very quickly because I think it's really easy to, um, kind of see the regulatory agencies as part of the way or not friends, um, uh, make things more complicated. But, um, I think we've been really fortunate to, uh, engage with some, uh, uh Regulator for Alliance and regular next year is huge forward locations. We wanted to be very flexible. And actually, um, took time out of their very busy schedules to be here at our conference representative from the FDA here in the UF administration, as well as representative from, uh, CA, uh, I think It's very open-minded. Dr. Chris said there are certain kind of statutory standards that they have to appear to, but within that, there's a lot of eagerness to find a solution that actually does enable therapies to come, uh, to the market to not. So I think that's a really encouraging development. All sorts of stuff that is about changing local climate and maybe decisions that all might agree with or disagree with, but I hope that all of the questions down with agencies, they are extremely thoughtful and extremely willing and eager to work with their community. I know it's not that we can start. So I think that building is actually a climate encouragement. Um, the other really critical Considuency, the fact that as a consideration, we as an organization really have to think about acting for the perspective of patients. End of the day, patient. We have to make sure that they are designed way that takes into consideration patients, practicality, et cetera. So that is a huge, priority for us in the topic of our next law, um, to buy our direct patient services, uh, And, uh, Dr. Sam Low, not Dr. Sit Lazinski and Tim Lowe, who have, uh, together secure headed a really important project to understand various challenges varying So we're really good to share the first line being all to have a community wide survey that we have been, uh, designed to understand What patients are seen when considering accessing participating trial. So I really want to take the FN and particular edge statement really followers throughout the budget for participating sessions to create the final report, which, um, my comment to our presenter tables. Um, it helps us ask many questions and understand not only So you might agree from and not hearing about clinical trial from Dan about from getting to the point of being able to be tested in the clinical trial trial for law. Um, but if the clinical trial is hand completely in them Um, and so successfully enrolling and retaining many persistents probably grow challenges across many different customers, and in order to be going to be challenging all start out, and um, many are dealing with physical challenges after payments that difficult Trial to private differently. Uh, so clinical trials we're going to see their design to reflect the reality looking at the person. Uh, so we can do that studies and from our community, what makes a trial easier to consider in terms of means, and what makes the particular sort of even out of reach, and what you Throughout the process and so large strategy designation. So, um, in this, uh, survey, almost three hundred and fifty people participating, two hundred and eighty-six patients and sixty-eight carrier courses. We offer center eight four languages and responsibility located in thirty-five hundred service. And, um, we began the process with several listing sessions describing the content of the survey, and we finished up with investments through your experiences and priorities for your depth. Um, and I know many people in this room participated in the process, and to you and to everyone who participated, thank you for taking time to share your experience. Hopefully, uh, you're input may much much clear understanding of and rational reality for key five is that I would talk about today. Uh, that the first thing And that's that for democratic characters in mobile product, but I need to be understand. They need to be acceptable and they need to be mostrated. So one of the first questions, which you mean well, I would cause you a fifty-three percent Yeah, they're open to all. Um, the desire of your tumor is seventy-four percent during diversity of the first one to grow. And there are multiple factors. I apologize, I don't know why so small, but there are multiple factors that are important to people on considering trial. Of course, reducing for stabilizing tumor, number one in the first field. And about three quarters of patients have been, uh, just helping progress for community, progression towards the, progression towards the cure, but also keeping ability on top of the impact of the patients and families. And the entire order aspiration of our key messages, um, like the different society conducting trial. Another key message, um, from the study is that you all of you might tell us. So we asked our survey receiver how likely to participate in a physical trial, recommended trial, in Atlantic policy. So eliminate the tumor yet from that point. To the size of the tumor, eighty-four percent, stabilized the tumor out to thirty nine, thirty-four percent, stole a lot of interest. We also have fifty-one percent of patients, fifty-five percent of caregiver, they would participate in terms of manage quality of life. And there's a So we also have a lot of questions about the research participation, and there's many. Um, first and foremost is personally subscribed. Um Also financial concerns, insurance, alcoholic off, and then there's a lot of concerns by all, so it's not a little important. Um, the other major barrier that I think for a lot of us are travel. Um, almost half of patients that the trial is too far away, you're not gonna travel to, patients would not go. Um, and if I don't participate in the trial, three quarters of That the data over now on the track is along the way. Um, so the trial can fly hard, so by lake, um, but we get onto the left that's really taken. The trial was really asking for the trial, this cute over that by the So, well, it's because of that, the quarter of foundation created a consolidant trial assistance program. Um, we have to work assistance just about a quarter had worn it out of the trial assistance program. But when we tell them about you can see that eighty percent of patients have carried on the day, they would be more likely And I was doing today in their, um, service, um, and we're doing a creative way that was foundation in nature trial. So those active lines around information gas, and you see in the study, um, the patient secure results like clear So one of the discovery statistics from the survey was how many patients thirty-seven percent were even here with the fact that there are no trials out there, the jobs forty-seven percent carry on. Um, in the form of your patients are valve trial More like the airport. So the numbers on the bottom of the team topics are very familiar seven seven percent. Definitely interested. It drops to thirty-five percent. We're just not familiar, and into the team's conflicts are dumped down a lot on trying. So education is critical in, uh, looking at the knowledge participation yet. We went on to ask most different questions about, um, the most important things for trial conscience and designers to think about when the patients are considering trial. And the consideration, first and foremost, we will tell us clear information and relations about what the cost and side effects may be, uh, as well as potential benefits. Large majority of task forces Step by step walk through what we're after the trial for expectations on health trial form up to 15% of the patients are in collection to the payment trial to make sure others to be able to case the payroll to be targeted integration. These follow might follow to the trial to play itself Navigator coming to the foundation, what is insurance over, what that talk is, currently paying towards those, and then patients also want, um, direct communication, not just trialty, but also the healthcare. We went on to ask, uh, what most important for trialty certifications for caregivers trials And the patients are pretty no longer, but they're really working the single point of contact when you understand after hours contact information. And then just keeping up to date with trial. So we all don't have this bunch of questions trial to five, um, pre-calipation. And as I mentioned earlier, the possibility of carrier to travel to the patient, uh, overall forty percent of the possibility of software to be a higher amount at that patient carrier and highest amount of infection capital One child just that, you know, I'd be pretty surprised if they did a lot of patients live with that thing. Um, this sort of change of that subject. So given that invitation we did have some college question about patients volunteers to pay to act as well to the judge, and it's one. So twelve percent tall as new year level in the trial or if you go to the trial, it's jumped to forty-five percent. Um, package twelve seven, and fifty-nine percent. They were first to pay and push the future accepted or the two armed correct. Um, uh, very first patches control. So bottom line in terms of trial design, should shoot back in control for crops over design over whenever possible, and to decline that the institution. Another key finding was around Um, and how important positions are patients for most trials. So when it comes to patients in carriers, one of the problems traveled to the most traveling to the patient. Number one is actually foundation. Um, we were reaching out to the foundation, of course, actually foundation. But all of those drugs are positioned by college, um, by far from Any other passenger. Um, and we know that because surgery radiation remaining treatments for the priority recurrence of discussion, pastor theory of total trial loss occur later in disease work. But it helps for other cancer organizations reinforced this phenomenon that we call diamond effect. Uh, patients look to their healthcare providers for each one of patients. Um, we have many people that actually focus their position. Uh, now the clinical trial is took twenty-five percent. I'll have that in the chat to jump up to her actually participated. Obviously, uh, in this study that a priorization died on healthcare One of the top motivated clinical trial, um, introduced the trial early, even hypothetically, um, or the particular education designed to learn out of rusty learning And that's around the all clinical trial or sometimes. treatment talking about given that there are no drug therapy it's no surprise that most patients are comfortable with the ICO in the optimal treatment but what the measure is that we have those participation trial already seventy five percent that they were not off the treatment to trial So we gave people some messages, um, some positive scenarios to try to information strongly preferred overall to treat that women for additional information. Um, in the case of Your document trial was confident. Um, there's a clear plan for how to match, and the trial travel has been. So for positions are approved, you will leave the trial to option to be appearing to wanted value. And the last slide is around, um, how important to build time of care into five trials wherever possible, uh, patients judge trials, not just by them results, but whether they procure the worst more than treated individuals. In our survey, um, one of the clients was that Nations want the higher generative care. So in our follow-up there, what you mean by that? Transitions like, uh, numbers of child subjects proactively communicating, closely monitoring, uh, healthcare concerned high clean environment, um, or some of those worst things that patients want. Um That among the we talk to participated in the model to have a low satisfaction because we're around a lot of quality of life in the year. Um, so as far as you can think about how many cases are where they are for the cancer study effect, management plan, structured emotional check in modern withdrawal mission And we don't want the cause all the trial to the location. So what are we going to do? Um, now that we have the design, uh, into my call experience to prioritize the team The next step is ensuring that what the order helps shape future research care. Uh, so the foundation will bring the insight to try sponsors, investigators, trial teams, uh, patient priority, informed decisions about random trials and design, uh, logistics around them, the communication during the trial, the support that's offered, and it's already in the Platform trial design and direction dispatch called access control and process already there. Um, we will also be depth in our position, um, to the strength of the conversation that patients have. When an addition before trial becomes an option, um, and all a lot of guarantee that the platform trial And other future research, and our goal is to ensure that your needs and perspectives are considered both while the children are being designed and same moment. And we will also continue to write clear trustworthy information to help you understand your options and personalized guidance to help you make most informed decisions about your care. At any date of your time, certainly have experience trials. And if at any point you decide to participate in the trial, our patient had a beer to help you identify options and navigate the screen participation process. And, um, for those new joint trials, as I mentioned, in front of the trial, this is programming available to help relieve so much financial burden of participating. Um, and so thank you again for sharing your thoughts and time and your experiences with us within that. Uh, I don't know if you have experience with other studies like this. How do you like to merge a more important factor in your study than in previous studies like question and I don't, know that we have. I, yeah, so we, yeah, um, I think that that last and yeah, um, we've done this type of work for several different patient organizations about the cancer space And quality of like inmers, and I, was kind of talking to the patients in the room here, uh, this morning, I, I understand a lot. Um, there's also more skepticism among the talking about among the population welter possible organizations we work with, and I think part of it is the trial we trump in. Uh, so um, you are, a special, um, and different, but also just a lot of careers. I'm just curious. Say your guy's doubt, your place out of the. Has there been any clinical trial that showed efficacy that say was far away from the patient? In my case, I'm gone pretty far away from very fortunate to take manage clinical trial systems program. But, uh, it's shown, uh, efficacy, uh, closer. Something like off labels, and that, uh, you're now. So you're saying if you participate in the trial and it's going well for you, and then you switch to off the therapy to finish down to trial. It's been talked about and there are a few people that have looked at that more happy out there. Do something worse for you in two years and you're on a trial too much Um, and it, seems to depend, uh, like a lot of off the coverage on what you've published. So if the trial published any insurance results, anything like that, but it's continued. It seems, it makes a lot of sense that an insurance company would look at an individual patient's response, and if you're responding as on what they would mean to say, okay, this makes sense. And unfortunately, it's not doing it. Um, but we'll keep trying. Um, and the partnership with Nation Hacking Foundation that I mentioned in Bible, um, is actually working when some module company write helps you have a lot of different things.