This is our discussion with Keith Berelowitz which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and not a transcript. This was done to improve readability.
Interviewer: Welcome to today’s episode of the podcast. The topic of this episode is how to improve patient engagement in clinical trials. This remains one of the ongoing challenges for everyone working in the pharma and biotech industries, and so far, there is no simple solution to this problem.
My guest today is one of the people dedicated to finding solutions to low recruitment in clinical trials. His name is Keith Berelowitz, who has worked for many years in the field of patient engagement and recruitment. He is also the founder of pRxEngage, a platform designed to address the issue of how we can recruit more patients for clinical trials, and he will tell us more about it shortly. For those of you who have been in the pharma and biotech industries, you probably know him as he is the chairman of the Fulham Research Ethics Committee.
It’s truly a pleasure to have you here with me today, so thank you, Keith, for joining. I’ll start by asking you the first question: Could you tell me a little more about your company and your work, and what you’ve been doing?
Keith
It’s good to speak with you and thank you for giving us the opportunity to discuss a bit more about what we do.
pRxEngage is a health platform designed to engage patients, help educate them about clinical trials in general, different medications, therapeutics, and more. It informs patients of ongoing clinical studies and empowers them to participate or apply to take part in these trials. We focus heavily on the patient’s journey, and we’re here to assist, support, and guide them along the way.
Interviewer: Yes, I had a look at your website, and I find it quite interesting because I saw that you also have the option to provide a more layman description of the clinical trials. So, how does that work? Do you have someone who extracts that information from somewhere, or do you use AI? How do you manage that? If you could give us a little more information.
Keith: We list well over 12,000 studies, mainly commercial clinical trials. We also include some academic trials, but most of this information comes from publicly available sources, such as clinicaltrials.gov or other public registries. That is how we manage to list so many trials; it would be impossible for a human to create these simple, easy-to-follow study summaries manually. So we have developed an AI algorithm to process this information, which will then generate a brief summary of the study along with an overview schedule.
And we do that for all studies, but then for the companies we work with, we have a commercial model where we also take the patient information sheet. We also gather the inclusion and exclusion criteria, and we use that information to create the summaries and one of the assessments we perform for the studies.
This provides a much more detailed and data-rich summary for patients. However, ultimately, our job is to inform patients, and we also recognise that not everyone speaks English as their first language, so we translate on screen into 45 different languages, working with a number of wonderful translators. We know the translations are not perfect, they are not as good as those of a human translator. But as one of my colleagues often says, ‘the enemy of good is perfect.’ It’s better to have something that allows more people to understand what it is we do and then beyond presenting the information on the studies.
We use the inclusion and exclusion criteria to develop an assessment tool that assists the patient in understanding their medical suitability for a study, in their own terms and way. We recognise that many patients may not understand certain blood results or ECG data. Therefore, we use AI here to present questions in a way patients can understand.
We conducted all this development with a large group of patients who helped us refine how these algorithms function and the information we present. Ultimately, there is a short series of assessments.
Medical suitability is important, but a key part of our work also focuses on behavioural insights, examining how patients might interact with the trial, assessing their decisional conflict, and evaluating their mental fitness, not just capability or capacity, but their mental fitness to see a trial through to completion.
And finally, we have an assessment that helps us evaluate predictability, how likely it is that this patient will see the study through to the end. Ultimately, what we’re aiming to do is build awareness, followed by competence, and then relatability. These assessments serve that purpose, with the final step supporting patients to connect directly to the research sites where we have a commercial relationship with the biopharma company, and all site information is listed. In fact, I’ve just been writing a case study about where this process can go horribly wrong, and I plan to publish it tomorrow.
If the patient is unable to connect directly to the site, as we saw in this case, it took more than 11 emails and a couple of weeks to finally establish the connection. That’s why I strongly advocate for platforms like ours or others out there, where sponsors can engage with companies like ours to facilitate a simple, efficient process. This allows patients to seamlessly engage with research.
We conducted a survey some time ago; over 80% of patients showed interest in participating in trials or in some capacity, yet fewer than 30% actually did. We are now losing many patients for no other reason than that.
Interviewer: I understand, but that’s very interesting, and I think it’s an excellent idea and sounds like something that is very useful. So, how do patients get involved? Could patients simply come and register with you? How does that work from a patient’s point of view if they want to be part of your platform?
Keith: That’s the other point. There are several other platforms like ours that require patients to register initially, then they start to display data, or show a bit of data before asking them to register.
We are quite unique in that we don’t ask patients to register with us at all. We will request some limited contact details, such as name, contact information, email, and telephone number, but that’s only for patients who wish to connect to a site because we need to provide that information to the site.
As an ethics chair, consent is very important to me, so we have multiple layers of consent and touchpoints through the platform where we’re starting to collect this data, but it’s not until that final step that we do so.
Patients find us through various channels. This includes social media and direct searches. I’m quite active on LinkedIn and other platforms, and we also work closely with patient advocates. Additionally, we collaborate with several community groups, which are very important because this is where patients seek knowledge and look for action.
What is so important to us as a team at pRxEngage is that we want patients to spend as little time as possible on our platform before they move on to their action. That action is: I have found a trial I am interested in and now want to put myself forward for it. This can be achieved by facilitating this through on-page widgets with various community groups that seamlessly display the studies within the native community group pages, then guide the patient to our platform to complete the steps I previously described. And it’s working. We have had over 50,000 patients visit and use the platform in the last few months.
Interviewer: That’s brilliant because it’s very important for people to be able to find information. I know this myself, as I wanted to help my parents’ neighbours who had a rare genetic disease, and I was trying to find a clinical trial for their son, who was 16 at the time.
I work in the field, but it took me hours just to narrow it down to that particular genetic disease, so I could find something. I think what you’re doing is really good and very helpful for research and for patients as well in finding information.
Keith: Thank you. What motivated me to finally do this was when I was searching for a trial for myself. Now, bearing in mind that I’ve worked in clinical research, patient engagement, and operations for over 20 years, you would think I would know where to go and how to navigate. I gave up and thought, if I have that background knowledge, either I’m particularly stupid and who knows what I’ve been doing for this long, or the system simply isn’t working as it should. There are good parts, I think.
Now is the time to do this, especially with the advances in technology that have caught up with the human brain in this regard. But what is absolutely critical is that you combine domain expertise from a technological perspective with genuine domain expertise. I’m not talking about having worked in patient engagement for six months and claiming to know everything, but a real understanding of how patient journeys evolve. Bringing that together is how we can begin to find solutions.
Interviewer: That’s brilliant. Thank you so much for your explanation and for the great work you’re doing.
My other question was, according to you, what could be the main reasons for clinical trials not recruiting patients? Could it be the design of the protocol or the resources at the hospitals?
You already mentioned that patients are interested, so it appears that a lack of interest from the patients is not the issue. So, based on your observations, what do you think is the reason for all that we see in clinical research?
Keith: I believe the first point to emphasise, as I often mention, is that nearly everyone involved in clinical research and innovation is doing so for the right reasons.
There are very few people I’ve encountered whom I wonder why they’re in this particular environment. However, I believe this is a perception held by many patients, thinking that pharma has done something wrong, the research sites have mishandled something, or their community groups are at fault. Conversely, Pharma often accuse patients of being difficult, leading to a lot of finger-pointing and a divide of them versus us.
We need to change that dynamic first. I really want us to understand each other and everyone’s reasons. I always ask people during a call or when I meet them for the first time, to tell me their origin story because I want to understand why they are here.
I haven’t yet met anyone working in a biopharma company who does this because they enjoy failure. Ultimately, biopharma is developing drugs where you’re more likely to fail than succeed, as shown by the fact that not every molecule reaches the market, and not every therapy is a breakthrough.
We have to go through many failures, so you need to be quite a resilient person to do this. In terms of what’s going wrong, it’s not one thing that we could target with a silver bullet, and that would fix everything. If that were the case, we would have solved it years ago. It’s a combination of challenges. And again, that’s why it’s so important to involve all the stakeholders.
Patients want to be involved in research, but they prefer to do so early. Therefore, a key requirement from an ethics perspective is genuine patient participation in the design of the research, along with evidence of this involvement in the appropriate manner.
I recently shared a post. Trying to figure out not just a single definition but what principles we should aim for to demonstrate true engagement. True engagement might mean engaging three or four patients, which is acceptable for an ultra-rare disease. However, this approach isn’t suitable for more common conditions like hypertension or type 2 diabetes.
What kind of involvement has to happen and when does it occur? It varies for each trial. There’s no one-size-fits-all approach, or it becomes a tick-box exercise. But we also need to recognise that we’re not making television sets or cars rolling off a production line. We are developing drugs, and everyone reacts differently. Things take time, and sometimes they take longer than they should. However, if we look at this from a human perspective and use technology to support us, that’s how we can start to improve it. So, it could be travel distance, the introduction of decentralisation, or expanding decentralisation of trials that starts to move the needle. Alternatively, it might be presenting information in plain language or connecting patients directly to the sites.
There are many things we need to consider. In fact, we recently received the results from a survey we conducted a few months ago, and nothing stands out as clearly wrong. However, the overall message from all stakeholders is that we haven’t quite reached our goal. We still have some way to go. The good news is that we have the technology and the willingness. If you possess both, along with the right people who are ready to act rather than just talk about these issues, progress can be made. But I think it’s important to recognise that some of these advances will be incremental.
Interviewer: That’s it. I completely agree with you. If we have the will, we’ll do it in the end. I agree with you on this one.
So, you touched on this a bit already, but I want to know what else we can do to engage people more. You have different communities, and some people don’t necessarily have the basic health knowledge to make these decisions. I believe that’s one of our biggest challenges in clinical research, if something could help someone, but that person doesn’t have the understanding of how it could benefit them, it might put them off and they could be unwilling to participate. They simply might not have the knowledge to grasp the concept. So, how can we address this? What’s your view on that?
Keith: Two things: education and relatability.
As far as I’m concerned, if I were to present this to you and you knew nothing about clinical trials, and I said, ‘Oh, you have this medical condition, why don’t you have a look at this clinical trial,’
Now, if you’ve never heard of clinical trials, your defences instantly go down. Even if you’ve heard of clinical trials, you start to wonder why you’re being asked again, and your defences begin to weaken. It is a human trait, quality, nature, or whatever you want to call it. Being cautious is easier than saying yes. In most cases, it’s far easier because you can shut it down or move on; it hasn’t impacted your life.
So, for me, when I consider education and relatability, first we need to help people understand trials, but how do you do that? You need to make it relevant to their daily lives. Use analogies. I’m writing a book with a colleague, and we’re blending everyday analogies into it to relate to clinical research, how it’s conducted, how you can get involved, and what to expect while connecting it to common daily experiences.
In fact, when we launched pRxEngage while trial matching platforms or trial finder platforms existed, most of the general population didn’t see them. So we related this analogy to how your clinical trial matchmaker, similar to a dating app, will present you with opportunities of hope.
We use the terminology ‘swipe right’ in research, so it begins to familiarise people. Clinical trials involve populations who may not have been aware, but we do so in a way that uses language they understand. At that point, we can start the education process about what clinical trials are, how to get involved, what to expect, and the different types of therapies. Then, returning to relatability, we ask: how does this trial relate to you, your life, your future, and those around you?
Interviewer: That’s perfect. I have an example for this because I used to work on a clinical trial at a hospital that had many African Caribbean participants, which I found very strange. So I asked the nurse, how did you manage that? how did you persuade so many people to participate? They said that a patient who was very satisfied with the study, an African Caribbean woman, spoke to others because it involved a chronic condition where people know each other, meet regularly at the hospital, and so forth. Her positive experience encouraged her to convince others to come forward and participate in the trial.
So, I thought that was quite amazing. I haven’t seen it since that clinical trial, but I believe it might be another way of approaching it. Perhaps if we involve patients who have participated in clinical trials a bit more in educating other patients, it could make a difference. Hearing it from someone who has your condition and has lived the experience seems more effective than us trying to explain it from a scientific perspective.
Keith: Of course. Who do patients trust the most? It is their friends, family, and so on, as well as their clinicians. So, they may ask their doctor, but you will want assurances from your friends and family that they are comfortable with this. And that example you gave, that’s something we’ve always employed as a, not a tactic, but a necessity if you can.
Assist one patient in explaining to another their journey, including what they are likely to encounter good, bad, or ugly. This helps the patient decide if the study is right for them before enrolling, rather than dropping out afterwards. Dropouts can confound the data and create challenges for the patient, the pharmaceutical company, and the research site.
It’s another initiative we’re working on at the moment. We’re doing quite a few things, but again, that patient voice and making it accessible in a way that isn’t obtrusive, yet allows patients to meet with other patients either remotely or watch videos of patients sharing their experiences to help them understand that they’re not walking this path alone. In fact, we have a meeting coming up in London; we’re speaking at Patients in February, and the main theme is that we all walk different paths, but we walk together.
We face different conditions and challenges in life, but our stories are quite similar. If we learn from each other, we can build greater strength to get through together.
Interviewer: Thank you so much, Keith. Yes, I absolutely agree with this one.
And my final question, which I’m always interested in, is what could regulators do to assist us? So, my question is: what could the regulatory agencies do to help with recruitment? We often see it as primarily a pharma company’s problem, but I believe we need to consider other perspectives. From their point of view, what do you think regulators could do to support recruitment in clinical research?
Keith: I believe one of the improvements needed is better communication. For example, I was chairing an ethics committee meeting on Monday, when one of the applicants submitted their PPI, which is their patient and public involvement in research. To be honest, it didn’t quite meet the standard; it wasn’t sufficient. I asked whether they knew, and I also asked the HRA members who support us, and they do an excellent job, where biotech, pharma companies, and others like yourselves find this information. It’s often buried on websites and needs to be more clearly highlighted. Improved communication of our expectations in this regard is essential.
But beyond that, listening is absolutely critical, if you’re going to present this patient information, regulators need to listen when patients say they support research. But the research needs to change in some capacity, one of the big issues currently is the need for placebo in late-phase trials, and the necessity of this. Yes, from a scientific perspective, I understand it, but from a patient’s viewpoint, would a patient with a terminal condition or a disease that is destined to progress and only worsen be willing to be on a placebo for few years?
Consider asking yourself, would I permit a family member to do that? The likely true answer is no. Therefore, listening to patients and support groups is important, but to do that, you need to conduct good PPI. You should present the data in a way that is not accusatory or demanding, but rather like this: show the data and then offer potential solutions. Don’t expect others to generate all the solutions, but emphasise listening and communication, which I would say are key for regulatory agencies.
Interviewer: That’s perfect, and I actually completely agree with you because I have seen quite a few, particularly in Alzheimer clinical trials where they’re using placebo for patients with mild or moderate Alzheimer’s.
I’ve seen in oncology studies where there’s demand from the regulatory agencies to have placebo, so I completely agree. I wish we could find a better option to focus on the scientific aspects without using a placebo.
Keith: Using a placebo is appropriate for some scientific studies. However, at the right moment, for the right study, and during the right phase, there are instances where it may not be necessary. Interestingly, regulators are considering options that involve eliminating the need for a placebo in certain studies or at specific times.
When talking to the regulators about this, they explain it to you. But they explained it to you one on one, and that is the communication piece. So many people aren’t aware that this is what we might potentially accept.
I think the UK is brilliant with its scientific advice, although it takes a while to organise these meetings where you can engage with the agency and put forward your ideas. I know other countries do this as well, and I believe that better communication and a willingness of regulators to genuinely listen and consider the solutions presented to them, then build upon them.
