The New Rules for Patient Recruitment in Clinical Trials
Learn about best practices for patient recruitment, one of the biggest concerns in the clinical trial industry. We’ll discuss the importance of precision recruitment and site-follow up, as well as patient recruitment challenges like diagnosis, eligibility and diversity. Joining this week’s discussion is patient recruitment expert, Rachel Lind of Antidote.
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Learn about best practices for patient recruitment, one of the biggest concerns in the clinical trial industry. We’ll discuss the importance of precision recruitment and site-follow up, as well as patient recruitment challenges like diagnosis, eligibility and diversity.
What’s the number one challenge with clinical trials? [03:03]
The number one problem with clinical trials is speed. Research isn’t happening as quickly as it should, and patients are waiting too long for new and better treatments while sponsors are spending too much money and time. The most effective way to address this problem is smart and efficient patient recruitment strategies.
What’s the importance of patient recruitment? [03:45]
There’s a gap between what patients need and the ability of clinical research to address these needs. About 80% of clinical trials are delayed or stopped due to enrollment issues, meaning that the drugs take longer to get to market or they never get there at all. Some disease prognoses are shorter than the average amount of time it takes for new drugs to get to market, which is 10 years. These patient stories illustrate the necessities of fixing the issues with patient recruitment from the patient side..
Why does this gap exist? What are the challenges to recruit patients in clinical trials? [04:40]
There are a number of different factors, such as complex protocols with increased eligibility criteria, making trials harder to recruit for. Additionally, there’s a lack of patient awareness around clinical trials. They don’t hear about trials because doctors rarely bring them up, or they have the misconception that trials are only for people with no other options. Education about clinical trials is crucial to improving patient recruitment efforts.
How do complex protocols effect patient enrollment? Are these trial design problems, or just ones that require a specific approach to recruitment? [06:06]
The increased complexity of protocols mirrors the increased complexity in the science of the drugs being tested. As medications become more targeted, especially in therapeutic areas like oncology, it has become more difficult to find patients who can participate in clinical trials. Precision recruitment techniques, with very targeted patient outreach, are more effective at finding patients who meet specific trial criteria.
How has the role of the patient changed in the recruitment landscape? [08:31]
Patients are becoming their own advocates by doing research on their dignoses, joining patient communities, and actively looking for treatment options. When running patient recruitment, it’s important to understand the voice of the patient to communicate and engage with them where they’ll be most receptive.
How can other clinical trial stakeholders reduce site burden through patient recruitment? [09:42]
In the future, the ability to measure various aspects of airway function will improve due to the shift towards personalized medicine, with new methods regulated and approved by the FDA.
What might sponsors be surprised to learn about digital patient recruitment technology in clinical trials? [11:39]
There’s been a slow adoption process for digital patient recruitment technologies, mostly due to the changes it can require to a sponsor’s internal processes. The industry is still relying on traditional advertising tactics for recruitment, but the digital world has untapped potential. Almost everyone is online or using a smartphone, including the aging population which is more tech savvy than it ever has been before.
How can patient recruitment address the issue of diversity in clinical trials? [14:50]
In June 2019, the FDA issued draft guidance on the importance of increasing diversity in clinical trial populations. It’s often incorrectly thought that communities of color are not interested in taking part in medical research. However, research teams and recruitment companies need to cater their outreach in a way that contextualizes clinical trial opportunities, addresses historical concerns, and gives people the information they need to feel confident about volunteering for clinical research.
The patient recruitment market is expected to continue to grow into 2020. Where is it headed and how will it continue to evolve clinical trials? [18:10]
Increased patient awareness about their health decisions and data will shape and impact many industries, including patient recruitment.
[Intro]: Welcome to Trial Better, a podcast series where experts discuss clinical trial best practices and take a deep dive into the latest industry trends and technologies. On today’s episode we talked about the changing landscape of patient recruitment. We’ll also look into how patients are becoming their own advocates, the importance of diversity and patient recruitment, and the ability to reduce site burden through digital recruitment. Leading this conversation is host, Jason Eger, and expert guest, Rachel Lind of Antidote. So, let’s not waste time and dive into this episode of the Trial Better Podcast.
Jason Eger: Welcome everyone to the Trial Better Podcast. I’m your host, Jason Egrr, director of organizational readiness for ERT. On today’s podcast, we’re going to talk about everything patient recruitment, the changing landscape of patient recruitment, some solutions that help improve recruitment, and finally the importance of diversity in recruitment for your clinical trials. But these points really are just the tip of the iceberg. Joining us for today’s conversation is recruitment expert, Rachel Lind of Antidote. Rachel, welcome, and thanks for joining us.
Rachel Lind: Hi, thanks so much for having me.
Jason Eger: It’s great to have you. Why don’t you tell our listeners a little bit about Antidote and about yourself?
Rachel Lind: Yeah, great. So I’m the director of business development at Antidote. I’ve been at the company for over four years now; living and working in our New York City office. And just a little bit about antidote for people who may not be familiar with the company. We are a digital patient recruitment company. And in my role, I’m focused on what we call precision recruitment, which are basically just a group of strategies and tactics that we use to help our clients accelerate their clinical trial recruitment timelines, which is ultimately, to achieve the goal of bringing new treatments to the market faster.
Before coming to antidote, I worked at a biotech startup. And before that, I worked in clinical operations at a large pharmaceutical company. And what drew me to clinical operations was really working in the lab when I was in college. I was studying biomedical engineering, I worked in a tissue engineering lab, you know, very different from what I’m doing today. And in the tissue engineering lab, we were studying the incredibly complex coordination of proteins involved in the development of ligaments in mice. And I discovered during that time that I was way too impatient for this type of work, just knowing that the results of our research may never potentially reach patients, and if it did reach patients, it would take well over a decade to get there, so I knew I wanted to be involved in researching new treatments that could help people right now. So that’s how I got into clinical operations when I was working on a US medical device study. And that experience really guided my career choices from then on.
Jason Eger: Yeah, what a great diverse background from the research into the execution of the trials. But so now we’re going to tap into your expertise, Rachel. I’m just curious what your thoughts are. What in your mind is the number one problem with clinical trials?
Rachel Lind: I think the number one problem is speed. Research just isn’t happening as quickly as we need it to, patients are waiting way too long for new and better treatment options. And sponsors are spending way too much time and money on getting these treatments to the market. And so the main driver that we have to address this problem is smart and efficient patient recruitment strategies, which is where I have spent the bulk of the last four years really working on you know, solving the speed problem.
Jason Eger: And I love it. I mean, we’re getting it to the patient faster. So what drew you, Rachel, to patient recruitment?
Rachel Lind: Recognizing this gap that we have in the speed and in getting patients into trials that 80% of clinical trials are delayed or stopped due to enrollment issues. And that just means that drugs are taking longer to get to market or they never get there at all. We work with a patient advocate at Antidote who has ALS. And he said something really powerful to us. He called out that research is moving so slowly, that the average length of a new drug coming to market, which is about 10 years is actually longer than the average length of survival for someone with ALS.
So when you hear these types of patients stories, and you have patients demanding treatment options sooner, I mean, that really motivated me to work on fixing the issues with patient recruitment from the patient side and working with the patients to help get the treatments to market faster.
Jason Eger: Great, so there’s this gap that exists, right, in getting the drugs out there, but what are some of the other factors that really make a study, difficult to recruit for?
Rachel Lind: Yeah, there are a lot of different pieces to this problem. One of the things that I see in my day to day work is extremely complex protocols. The number of eligibility criteria has significantly increased over the past decade. And this just means that trials are harder to recruit for, because there are more criteria that patients need to meet to actually be able to enrol into a study. And one of the reasons for this is just we’re seeing more targeted therapies, we’re seeing more complex requirements for actual study endpoints.
And, I mean, aside from the protocols, which is a whole separate topic that I would love to talk to some experts about the protocol design as well, there is just a general lack of awareness with patients around trials. Patients don’t hear about trials because their doctors rarely bring them up. And there is a misconception out there. I mean, even among my friends and family – and I work in the clinical trial space – that trials are only for people who have no other options. So we really need to educate people that there are trials for all conditions at all stages of different diseases. And, you know, clinical trials are how every drug currently on the market got there in the first place.
Jason Eger: Right on and agreed, and you’re talking a little bit, I want to hit on it briefly, when you talk about complex protocols. What is it that you really mean? I mean, are there problems with the design of the trials? Is it a specific approach to recruitment that can help resolve this?
Rachel Lind: Yeah, I think that the protocols are complex, because either medications because they’re more targeted, especially in the oncology space, we see certain biomarkers and genetic mutations needed for trial participation, because that’s what the drugs are targeting. So we see increased complexity in the protocols because of the increased complexity of the science and the drugs that we’re testing. And we also see more specific endpoints that are being tested, and just different regulations that we need to meet, the protocols need to be reflect that in the design, right?
So at Antidote, we, you know, use what we call these precision recruitment techniques where we’re very targeted in our outreach, to make sure that we are able to find very specific patients. Because it’s not just enough to know the patient’s diagnosis or what they’re currently experiencing, but we need to know a lot of information about these patients in terms of their medication history, their dosages of their medication. So all these different factors that go into trial participation, we try to address that up front during the recruitment process.
Jason Eger: So really, I mean, you’re saving the sponsors and the sites really time, money and the burden of finding them the correct patients at the correct time?
Rachel Lind: Exactly. And I mean, sites are so busy, that we need to make sure that we’re sending sites patients that are actually you know, have a chance of qualifying for their study. And patients are so busy, you know, we always use the term patients, and I was at a conference recently where they urged us to stop saying patients and just start saying people and say humans because you know, we’re all patients in some right. We all know people who are patients in their own right. But we’re also people and we lead busy lives. And so it’s not in anyone’s best interest for a patient to, you know, go through all the work to actually try to sign up for a trial only to find out that they’re not actually eligible.
Jason Eger: Right. I mean, it makes complete sense, and I like it, using the term people instead of patients so I’ll use it now with you, and tell us about the changing landscape of people/patients in recruitment. I mean, what is it that is changing? Have the protocols become more complex? How is the role of the patient change in the recruitment landscape?
Rachel Lind: We see patients are becoming their own advocates. They’re doing a ton of research when they are diagnosed with a condition or their family members or their friends are diagnosed with condition. They’re joining patient communities and they’re actively looking for treatment options. So knowing this, about how patients have become their own advocates, when we’re running patient recruitment campaigns, we work with patient organizations to understand the voice of the patient in order to communicate with them where and how they want to actually be engaged. So there are patient advocates out there, who are patients themselves, who we speak to about, you know, different conditions that they have and what their vocabulary looks like and what catches their eye when they’re online looking for support and for treatment, so that we can be really sensitive to patients and talk to them in the right ways.
Jason Eger: So on top of the patients, one of the key stakeholders, obviously are the investigative sites.
Rachel Lind: Right.
Jason Eger: And so, sponsors give them a budget for trials, but they also are charged with executing the trials. Can you talk a little bit about reducing some burden, making it easier for the site as well as the patient?
Rachel Lind: Absolutely. So, as someone who worked in clinical operations, and one of my roles was managing the clinical study sites, calling all 30 of our sites on a—sometimes it felt like a daily basis to catch them. And then in these sites, I mean, I just remember how busy these sites are, and these study coordinators are doing a million things in their job other than just running their clinical study. And so we really want to focus on making sure that we reduce the number of patients that actually end up with a clinical study site, if those patients will not qualify, right?
So there’s a lot of things that we can do before we send patients to sites, we can do extensive digital pre-screening, we can do phone screening, we can do different types of lab screening and medical record retrieval. I mean, there are so many different techniques that we can take the burden off of the sites and bring it on to us to really make sure that the sites are happy and when the patient does arrive at the site, the site has an understanding that this patient is a qualified patient who has a good chance of enrolling into their study.
And I mean, ultimately, it’s up to the sites, the success of the trial. So if sites are engaged, and they are speaking to the patients and screening them and enrolling them into their trial, that’s a successful trial, if the sites get overburdened and overwhelmed, and they are not on board with any sort of recruitment strategy that you are employing, I mean, that’s when you’re going to have failures in recruitment.
Jason Eger: Well, and being in the industry, we know that sometimes there’s a longer adoption than we would like into the technology and healthcare industry in general, has been slower to adopt new technology. Can we say the same thing here for what you do it Antidote for patient recruitment?
Rachel Lind: Yes. So I mean, we were in digital recruitment, which is new in the last, you know, not new in the last three years. But close to 10 years ago when antidote first formed, it was very new in the space. And it is a slow adoption. And there are still a lot of reliance on paper and flyers and subway ads and radio, and all of those things are great. But there’s this whole new digital world and the internet and all these different social media and, you know, all of these places where patients really are interacting online. And so if we don’t take advantage of all of those channels, we’re really missing out on the vast majority of people, right, because everyone is online. Most people have a smartphone. And so it’s really important that we’re seeing the changes in digital and engaging patients where they’re really interacting. And one of the questions I hear from sponsors a lot of time and resistance to digital recruitment is they’ll have a certain patient population and they’ll say, “My patient population is just not—they’re not online. They’re not on social media. They’re not in your patient advocacy group email lists, you know, how are you going to reach these patients?” And what we really encourage them to think about, or to realize is that, you know, I don’t know about you, Jason, but my grandfather is on Facebook all day, every day posting pictures from his latest trips. And you know, the aging population is more tech savvy than ever. And we actually enrolled in early Alzheimer’s trial using social media, which is just a testament to the role of the digital age in all of our lives, regardless of age.
Jason Eger: Are you finding that less Rachel, I mean, I completely agree with you. I mean, I find that parents, grandparents are all online, texting, sending bit emojis, whatever it might be. I think we could kind of put that one behind us a little bit. Do you agree? I mean, are the sponsor saying, “Okay, you’re right?”
Rachel Lind: Sponsors are saying you’re right. And they are adopting policies internally that can allow digital vendors to actually recruit patients online. But I think that that is really where maybe the slow adoption process gets caught up in is, you know, what does this look like internally? What do our regulations look like? What do our standards look like? What do our SOP say? And so many sponsors are still working through what that looks like for them internally. But I mean, we work with a lot of different sponsors and use different digital techniques and so it is something that is being widely used, but there is still resistance and it is a slow process.
Jason Eger: So, Rachel, we talked a little bit about patient recruitment, and really about the effects of having diversity in your clinical trial. And as the example, side effects that men may experience differently than women do in a trial, or a treatments that may be approved for one population versus another. How do you see this being handled in the patient recruitment space?
Rachel Lind: It’s so important, and there are so many examples of different diseases and treatments that affect people of different diverse backgrounds. And diabetes and cardiovascular disease are really good example of conditions that do affect people. We know that they affect people of diverse backgrounds differently. And I’ve seen trials that have actually been executed to try to help address the need to have more diversity in these specific disease areas.
So I think Pharma as well as the FDA is really seeing the need to increase diversity in clinical research. This is evidence by the FDA recently issuing draft guidance on increasing the diversity and clinical trial populations. And it is so important. Nearly 14% of Americans are black, but they make up less than 5% of trial participants, and Latinos make up 18% of the US population and represent only 1% of clinical trial participants.
So clearly we have this huge gap in the representation that we have in the United States versus the representation we have in clinical research. And so I’m really excited to see the FDA and Pharma both trying to address this. And I do see it definitely, by Pharma clients having new trials that they’re running that do have very specific requirements for diversity in their enrollment. And this affects Antidote from a patient recruitment standpoint, because we really need to listen to the diverse communities that we are looking to engage because there are misconceptions that recruitment companies or sponsors have, for example, it’s often incorrectly thought that communities of color are not interested in taking part in medical research. However, we found that that’s just not true.
We conducted a survey last year of over 4000 patients. And we found that it’s actually not a lack of interest in research that slows down participation in trials. But really, we have to take it upon ourselves as research teams and recruitment companies to really cater our outreach in a way that properly contextualize as clinical trial opportunities for patients, and give them the information that they need to feel confident about volunteering, because it is such a huge step to take part in a clinical trial. And it is on the recruitment companies and on the research teams to make patients feel comfortable and excited about the opportunity to join a clinical trial.
Jason Eger: Yeah, and you know, we’re seeing that the same thing when we’re collecting these data. So as you talked about earlier in the complex protocols, as you talk about getting more diverse patients into the trials, we’re rolling out as an example for ECOA more languages available on the diaries for people to respond. So we’re seeing it too, and I think it’s a wonderful thing for the industry in general the focus on.
Rachel Lind: Definitely agree.
Jason Eger: So as here’s one of the stats that we’ve talked about, right? The patient recruitment market was worth 4.8 billion as of 2017. And we’re expecting it to grow at a rate of 15 to 16% up to 2020. Where do you personally see patient recruitment heading? How will it evolve as the market continues to grow? And what do you need to do to get ahead of the market growth?
Rachel Lind: I mean, I’ve seen so much change in the landscape just in the four years that I’ve been at Antidote. And I think what we’ll see in the future, is as patients become increasingly informed about their health decisions, and having ownership over their data, I think that’s going to have the biggest impact on recruitment and trials. People are more aware than ever of what data they have out there and what it’s being used for. And this is going to have implications across so many different industries that patients are really taking ownership of their data. And they’re deciding where and how their data will be used.
Jason Eger: I mean, Rachel, I think everyone can hear the passion in your voice. I hope that our listeners can and will. Saying all that and being in patient recruitment and really trying to make a difference, what inspires you, Rachel?
Rachel Lind: We all know someone struggling with an illness. We’ve all lost people who are close to us. And it just inspires me every day when we’re connecting people with research and just giving them a better chance at better science, better medicine, so that they can improve their quality of life or hopefully even save their lives in some of these trials. I have a personal family connection to the work that we do; so many of my colleagues at Antidote have personal connections. So I feel very lucky to just be surrounded by these people who we’re all just so deeply connected to the work that we do.
Jason Eger: Agreed, and we’re fortunate to have your passion in the industry, and thank you. I hope our listeners have enjoyed this as much as I’ve enjoyed speaking with you and learning about you and Antidote. Why don’t you give us some of your final thoughts?
Rachel Lind: Yeah, so the only thing that I would add, and thank you so much for the platform and the opportunity to have the conversation today, Jason. And I read something recently that I thought I really want to share, which is just that in one of our patient surveys, we found that 75% of patients listed that their motivation to join a clinical trial was because they wanted to advance science. And that was actually the number one reason that patients listed as wanting to join a trial. And that just really struck me and kind of stayed with me that we have these people that are just so selflessly dedicated to bettering medicine and really bettering the world. I just found that really inspirational. And I think about that now in the daily work that we do.
Jason Eger: Rachel, thank you. That was great. And you’re right, inspirational. I think you’re inspirational. I’m inspired by it too and hopefully, everyone listening. Unfortunately, we’re out of time. And I think that’s everything. Thank you, Rachel Lind so much from Antidote for everything that you talked about today for teaching us. We learned so much today. I personally didn’t; hopefully, our listeners did. We talked about patient recruitment as far as giving patients options and really managing their disease state through effective recruitment, reducing patient and site burden, expanding clinical trials in the hopes of getting patients in expanding the diversity of your trials through patient recruitment. Rachel, thank you again for being our guest on the Trial Better Podcast.
Rachel Lind: Thank you so much for having me. I love having these conversations. This is what I’m passionate about and I’m so happy that we got to share it with everyone.
Jason Eger: Thank you and thank you again and again everybody, I’m Jason Eger from ERT. Thank you for tuning into the Trial Better Podcast.
[Outro]: That’s a wrap for this episode of Trial Better. Special thanks to Rachel and Jason. We have a lot to take away from this discussion on patient recruitment. Today we covered the changing landscape of recruitment and what needs to be done in order to recruit the right patients for your clinical trial. Thank you for tuning in. And as always, please comment, rate or review Trial Better on Apple Podcast or your favorite podcast channel. You can also send us a message at [email protected] Your feedback is appreciated and helps us deliver the content you want to hear. Again, thank you for listening, and we’ll see you next time on the Trial Better Podcast.
Rachel Lind has been working in patient recruitment at Antidote for the last four years. As the Director of Business Development, she works with pharma and CRO clients on strategies for meeting or accelerating their trial enrollment goals. Before coming to Antidote, she worked at a biotech startup and in clinical operations at a large pharma company. Her background in Biomedical Engineering and benchtop research shaped her understanding and passion for medical research.
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