THE PATIENT’S CLINICAL TRIAL JOURNEY
Trial Better host and ERT’s Director of Operational Readiness, Jason Eger, is joined by Mike Wenger, Vice President of Patient Engagement at TrialScope. As they discuss the roadblocks a patient faces when searching for the right clinical trial opportunity, they also explore changes the industry can make to improve the matching process.
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Tell us about TrialScope and your experience.
I am the Vice President of Patient Engagement at TrialScope. I used to work at the Michael J. Fox Foundation for Parkinson’s Research and also had my own company, Clinical Trial Connect, before it was acquired by TrialScope last year. I’ve been working in the clinical trial recruitment world for the past ten years. I am overseeing a new product called TrialScope Connect, which sets sponsors up for success when it comes to clinical trial improvements.
What typically motivates patients in a clinical trial?
Every patient is different and every trial is different. People are dealing with diseases that are often very urgent or difficult. Having a path towards a better prognosis, extending your life, and improving your quality of life are all factors that people consider when it comes to clinical trials. There are people who participate in clinical trials who know it might not improve their quality of life, but it’s something they want to do for the next generation. For other people, there is an awareness in recognizing no cure has ever come on the drug shelves without going through the clinical trial process, and they want to do their part to make sure science continues to move forward.
Tell us about the journey of a patient in a clinical trial.
The journey starts when a patient is first diagnosed with a condition, but following that, there are many different places where someone might become aware of a clinical trial for the first time. At that point, patients need an educational component to become familiar with the different terminology. Once a patient has that knowledge, they can decide if they are interested in moving forward and participating in research. Then, they have to find the right trial for them. Every trial is different and has different inclusion and exclusion criteria. Every trial is run at different site locations. There is a challenge around finding the right opportunities. Once a patient does identify an opportunity, getting in touch with that site is the next step. Then they go through the enrollment process. Ultimately, a patient will learn if they are eligible to participate in that trial. If not, they’ll have to restart their search process.
Do you see patients becoming more engaged in clinical trials and in general has this impacted clinical research?
Today, people are used to being very informed. Patients are surprised when they start the journey at how analog it is and how many roadblocks exist. One of the things that is problematic is that a lot of patients don’t know how to search for a trial that is the right fit for them. There is no easy tool to solve this problem, and patients have to tediously review clinical trial listings. In addition, if patients aren’t aware of how to search proactively, they’ll never know their full range of options. This denies them an informed choice. This is how standard trial-centric matching works, where the finish line is one trial and a lot of times a funnel is used to see how many patients need to be at the top of the funnel to get to the trial’s required number of patients. What’s unfortunate is that for all of the patients that weren’t eligible there’s not a great next step of action for them. For the enrolled, they might have missed out on the opportunity to be in another trial since they were only being screened for this specific one. We think about patient centric trial matching, putting the patient in the middle and asking what trials does this patient actually match to and allow them to make an informed decision.
What can the industry do to get to this patient-centric model?
There’s a lot of companies that are tackling this and whether the solution is a website or an integration, people are trying to do right by patients. It’s an opportunity to standardize how we talk about eligibility criteria and the benefit is that companies don’t have to reinvent the wheel. With TrialScope, they can now have a best-in-class platform to match a patient to all the trials that are a good fit for them.
What can sponsors do to motivate and educate the recruiters of their trials? How do we get them to be more knowledgeable about the trials that are out there?
The physicians are challenging. They have 15 minutes or less with a patient. Anything that is disruptive to their flow or takes up more time is something they aren’t going to use. However, there is a solution where they can help the patient to make a decision that is within the time of their appointment. Patients can review their matches in advance, get material in the waiting room, and by the time they’re with their doctor they have a decision and are fully informed. Now, the doctor can talk to them about that specific trial. A lot of solutions like that are possible.
How do sponsors ensure that they are being mindful throughout the patient’s journey during all of the phases?
Something that happens is that patients spend a lot of time reviewing their matches and they never hear back from the site. Sponsors can be more communicative with patients, even in an automated way, to let them know when a site has stopped recruiting. Let’s make sure no patient goes down a dead end and is waiting for a response that they’ll never get.
For the people that do enroll, the journey continues for them. A lot of times patients don’t know what happened with the trial. Making plain language summaries available in different languages and sharing patient data with those who participated in the trial can be steps towards increasing patient satisfaction with their trial experiences.
[Intro] (00:25): Welcome back to the Trial Better podcast. Today, we’re joined by Mike Wenger, the vice president of Patient Engagement at TrialScope, a platform provider that enables transparency and compliance and clinical research. In this episode, we’ll hear from Mike about one of the industry’s biggest challenges, patient recruitment. He’ll shed light on what a patient experiences as they search for recruiting trials and how sponsors and sites can improve recruitment efforts. Leading this conversation is host Jason Eger. Let’s not waste time. Join us as we listen to another great discussion on Trial Better.
Jason Eger (01:04): Hi everyone. Welcome to another episode of VRT’s Trial Better podcast. I’m your host Jason Eger, and I’m here with our guest, Mike Wenger of Trial Scope. Mike, welcome to the show.
Mike Wenger (01:14): Thanks for having me, Jason.
Jason Eger (01:16): It’s great to have you here. So, Mike, why don’t we get right into why don’t you tell us a little bit about the trial scope and tell us about your experience?
Mike Wenger (01:24): Yes. So on the vice president of patient engagement here at the trial scope, before I joined Trial Scope, I used to be at the Michael J. Fox Foundation for Parkinson’s Research and I also had my own company, Clinical Trial Connect, before it was acquired by trial scope last year. And so I’d say I’ve been working in the clinical trial recruitment world for the past 10 years. And in terms of what I do, a trial scope, I’m overseeing a new product called Clinical Trial Scope Connect, and it’s taking a lot of what we do a trial scope and helping our sponsor customers set themselves up for success when it comes to clinical trial recruitment.
Jason Eger (02:04): Great. So one of the themes that we’ve had here on Trial Better is the patient, right? And it’s all about the patient. And so what we’ve learned is that patients, they get into clinical trials because they want to advance science generally. Obviously, they want to feel better, but they really want to advance science. So in your opinion, Mike, what do you see what typically motivates patients in a clinical trial?
Mike Wenger (02:31): So every patient is different, every trial is different. There are some similar motivations, I think for a lot of people they’re dealing with a difficult disease. Some of those diseases are very urgent. And so having a path towards a better prognosis. Extending let your life improving the quality of your life, those are all, I think, factors that a lot of people think about when they think about what is the next possible opportunity coming out of clinical trials. There are many folks that participate in clinical trials knowing that it might not improve their quality of life, but it’s something that they want to do for the next generation or for their kids. And there’s an altruistic driver behind participating in a trial. And I think for many other folks, there’s just an awareness of recognizing that no cure, no therapy has ever come on the drug shelves without going through the clinical trial process and so they want to raise their hand, participate in research and do their part to make sure that science continues to move forward.
Jason Eger (03:44): And so when they do that, tell us a little bit want to tell the audience a little bit about what is the journey of a patient through a clinical trial? What’s it like for them to be enrolled?
Mike Wenger (03:54): So before you even enroll in a trial, the journey starts much earlier when you are first diagnosed with a condition and depending on the condition that you have, there might be existing treatments and therapies available, or you might have a diagnosis where there might not be any treatments available. And so at a certain point in time, you’re maybe talking to your physician, you may be visiting a patient advocacy group website, you may see in an ad on the subway, there’s a lot of different places where someone might become aware of a clinical trial for the first time. At that point in your journey, you have to better understand, well, what is a clinical trial? What is phase one versus phase three? What is observational versus interventional mean? And so there’s an educational component to just make sure that you are familiar with the different terminology of clinical trials. And then at a certain point in that journey, you’re starting to say, Ok, I’m interested in continuing to move forward. I do want to raise my hand and participate in research now, finding the right trial for you. So every trial, every trial has different eligibility criteria that might make you eligible for trial or there might be criteria that exclude you from participating in that trial. Every trial is run at different site locations. So there might be a site that’s within driving range of where you live. There may be a trial that is out of reach for you to participate in. And so there’s a challenge around just trying to figure out what are the right trial opportunities for you. But then once you do identify an opportunity, getting in touch with the site that is running that trial is the next step and then you go through an enrollment process from there that might include a phone call with the site coordinator. It might include going on-site and taking certain lab tests. And then ultimately you’ll learn if you are able to participate in that trial and the term is called randomizing or it’s possible that you might not qualify and when you’re disqualified, you have to go back and continue your journey, maybe going down a different path.
Jason Eger (06:14): So from your perspective Mike, do you see patients becoming more engaged in clinical trials and advocating for their health in general? Has this impacted clinical research? If so, just curious about your thoughts on how.
Mike Wenger (06:29): In today’s day and age people are used to being very informed. If I want to fly to London, I can go to a website, pull it up real quick and I can know all of the different airlines and options and prices and which data are available. I can make a decision and I can have a great experience of booking that ticket to being texted if anything changes all the way to boarding the flight and going to London. And so that consumer experience is something that we expect in other aspects of our life. And I think patients are very surprised when they start the clinical trial journey, just how analogue it is, and also how many roadblocks exist on kind of moving down this path and moving on this journey. So one of the things that are problematic is that a lot of patients just don’t know how to search for a trial that is a good fit for them. It’s easier said than done. There is no true Kayak that can help you solve this problem. There is a government website where all trials are listed called clinicaltrials.gov, but what’s problematic about that experience is the search capabilities just aren’t there. So if you say you’re a patient in the New York City area with a brain tumor, you’re going to match to one hundred twenty-five actively recruiting clinical trials that you then have to tediously review one by one to see if you’re a good fit or not. And then on the other side, you have situations where patients aren’t necessarily given a choice and they see an ad on Facebook and they click it and they’re only ever screened against one particular trial or their physician recommends a trial that the physician happens to be aware of. And so I think there’s a lot of instances where patients are denied an informed choice. And it’s just happenchance that one trial rises to the surface and catches their attention on a subway ad and now you’re not getting that true kayak experience where you have all the options in front of you and you can make that informed decision.
Jason Eger (08:46): So you’re advocating now, instead of just responses, looking for the patients, it’s the patients looking for the trials?
Mike Wenger (08:53): Yeah, I usually use the term there’s trial centric matching where the finish line is one individual trial. And a lot of times the terminology is used of a funnel. How many patients need to be at the top of the funnel and through the different steps of the process as folks drop off in that screening process, we may need a thousand patients at the top of the funnel to get to 10 patients enrolled in our trial. And I think what’s unfortunate about that trial centric process is that the experience for the nine hundred ninety patients that weren’t eligible, there’s not a great next step or call to action for them. They’re kind of sent back to Facebook and they’re just told you’re not a good fit for trials at this time. And then on the other end, for the 10 that did ultimately enroll, they might have missed out on an opportunity to participate in another trial that they are also qualified for because they are only being screened against one trial. So we like to think a lot about patient centricity. And a big part of patient centricity is patient-centric trial matching, putting the patient in the middle and saying what trials, whether it’s pharmaceutical company A or B or C agnostic to who’s running the trial, which trials does this patient actually matched to today and then let them make an informed decision from there. So patient centric matching is a great thing for the patient. It’s just difficult to do and practice.
Jason Eger (10:24): And so do you have ideas and what the industry can do in general to get there to get to this more trial centric model?
Mike Wenger (10:32): There’s a lot of great startups and companies that are tackling this and whether their solution is a website or it’s something that is integrated with the electronic medical record, folks are trying to do right by patients and match them to the right trials. There’s a lot of overhead to try to build these matching engines and these capabilities. So, for instance, the way folks type out there, their eligibility criteria on a trial today is, it’s an unstructured text field so anyone can write in whatever they want. And then what ends up happening in practice is the same concept of, for instance, in oncology a lot of times, and eligibility criteria are called an ECOG performance score. And if you have a score of zero, one or two or three or four, that will impact what trials you are eligible or ineligible for. But because it’s an unstructured field, there’s hundreds and hundreds of different permutations of how different sponsors or even different individuals at those sponsors described that same concept of an ECOG score. And so I think there’s a big opportunity to just standardize how we talk about eligibility criteria. And the benefit of that will be that now the various companies that are looking to do patient-centric matching don’t have to reinvent the wheel and try to solve this problem themselves with natural language processing and or manual review. They can now have a best in a class matching engine to match a brain tumor patient in New York City to all the trials that are a good fit for them. And hopefully, it’s not one hundred twenty five. Hopefully, it’s a much narrower list that actually is better targeted to that patient.
Jason Eger (12:22): That makes perfect sense. So with that, what can sponsors do to really motivate and I guess educate the recruiters of their trials? So as an example, physicians, right? They’re seeing the patients. How do we get them so that they’re more knowledgeable about the trials that are out there?
Mike Wenger (12:40): Yeah, the physicians are a challenging one, because if you think about a physician, they usually have 15 minutes or less with each patient and they have responsibilities beyond just informing a patient about the clinical trial opportunities. And so anything that is disruptive to their workflow or takes more time or has more noise than signal is something that the physician is not going to want to use and will not move forward with and so I think there’s going to be a great opportunity whereas we as an industry try to improve the matching capabilities of patient-centric matching, eventually there is a solution now where the physician can help a patient make this difficult decision, but do it in a way that works with the amount of time allotted in their appointment, maybe an opportunity where patients could review their trial matches in advance of their appointment, get some educational materials while they’re sitting in the waiting room on an iPad. And then ultimately, by the time they said. And with their doctor that they’re fully informed, they’ve selected a finalist trial and now the doctor can talk to them about that specific trial. I think there’s a lot of holistic solutions like that, that are possible. A lot of them are struggling to move forward because of the matching challenges that I spoke about earlier.
Jason Eger (14:10): So you’ve kept the theme up, right? It’s really about patient centricity and really making sure that the patients are at the center of the model here. Right? Ultimately, that’s what the trials for. How do sponsors really ensure that they’re being mindful of the patient journey throughout all the phases of a clinical trial?
Mike Wenger (14:34): Yeah, so I think as a sponsor, there’s a few things that you can take action on today. So one of the things that we see a lot is, again, to this eligibility criteria challenge. There are a lot of open standards and working groups that are trying to help solve this problem. And so as those standards develop, adopting those and implementing them, when you write up your trial information and post it to clinicaltrials.gov is a great starting point. I think another action that sponsors can take, and this is something that we haven’t talked yet about, is one of the things that happen, and unfortunately, way more often than we’d like to admit, is that patients spend a lot of time reviewing their trial matches. They find a trial that they’re a really good fit for. They go and they contact the site and they never hear back. And the reason they never hear back is because the site stopped recruiting because they hit their enrollment numbers two months prior and they’ve shut down their inbox. And so the missed opportunity here is it’s a very poor experience on that patient. They raise their hand they’re waiting patiently to hear back and they never get a response. And so as a sponsor, if you can build in a better feedback loop to know as soon as a site stops recruiting, let’s make sure that, that data point is updated in all the places, whether it’s clinical trials.gov or the recruitment organizations that we work with. Let’s just make sure that we keep that up to date so that no patient kind of goes down this dead end and is left waiting to hear a response back that they’ll never get.
Jason Eger (16:17): I mean, I think that was the great point, keeping that I mean, talk about patient centricity, that’s it. Just keeping the patient upfront, really, the sites I mean, we can all relate to how much they’ve got on their plate. But I love what you’re getting at as far as making sure that we close the loop with everybody, including the patient. Mike, it’s been great. How about any final thoughts for the audience today?
Mike Wenger (16:39): Yeah, I think the other thing that that’s maybe worth sharing is for the folks that do actually enroll in the trial, the journey continues for them. And so maybe you’re in a trial for several weeks or a few months. The trial ends and then it’s just a big question mark. What happened? A lot of times patients don’t necessarily know what happened with the trial or even what happened with their individual experience at the trial where they on the placebo or were they not on the placebo. And so, there’s definitely been a lot of strides the past few years in terms of making plain language summaries available in different languages and making those available to patients that participated in the trial and the broader patient community. And there are also more recent initiatives around actually giving patients data back for those that participated in the trial. And I think those are two great initiatives that I’d love to see more prevalent in the future.
Jason Eger (17:43): Mike, great, thank you, thank you for what you’re doing and keeping the patient first. I know that this has been very beneficial to everybody that’s going to be listening to this. And I think it’s super important that we keep this mantra and keep going with the patient first. So thanks again for being here, Mike.
Mike Wenger (18:02): Really appreciate it, Jason.
Jason Eger (18:04): Listeners, thank you all for tuning in. Don’t forget to submit any of your feedback to us at [email protected], and also, if you wouldn’t mind, leave us a rating or review at your favorite podcast streaming channel. We’ll see you all next time on Trial Better.
[Outro] (18:20): That’s it for this episode of the Trial Better podcast. Thanks to Mike Wenger for stopping by to discuss how the industry can address patient recruitment challenges by making the process more positive and productive for patients. Please remember to comment, rate, or review Trial Better on Apple podcast or your favorite podcast channel. You can also reach us at [email protected] Thanks for listening.
Mike Wenger is Vice President of Patient Engagement at TrialScope. A brain tumor patient and software developer, Mike is passionate about patient access to clinical trials. He is spearheading TrialScope Connect, the industry’s first patient referral collective. This initiative is creating a paradigm shift for patient recruitment, focusing on collaboration vs. competition.