Recruitment Challenges in Clinical Studies and How to Overcome Them
Many drug study sponsors, whether working with a CRO or directly with a study site, experience problems with recruiting patients to their studies. To gain insight on the challenges and typical paths to failure, as well as a wide array of solutions for successful patient recruitment, we spoke with two Alira Health experts, Annabel de Maria, Chief Patient Officer, and Chris Rao, Senior Vice President of Clinical Operations.
What are the most common patient recruitment challenges?
Chris: Right from the start, the base patient population is often a serious challenge. Sponsors need to understand what the potential pool of patients for the study is, whether these patients are located within the geography of the study, and how they will access these patients.
Another common challenge is protocol design. The criteria you develop for inclusion and exclusion restricts the possible participants who can enter the study. For example, if I have 100,000 patients in the pool, my protocol design may limit that to 20,000 patients out of the larger patient pool. You’re continuously limiting your patient population based on the way the study is designed.
I also see a challenge in patients’ willingness to participate in a clinical study. Patients are reluctant to participate for various reasons, including their physical abilities, lack of transportation, and the time commitment, including time away from work (which can affect income) or family. Sometimes patients don’t trust the clinical study process and have concerns about receiving a drug that’s not approved or a device that’s not cleared. These very human issues can further limit your patient population.
Annabel: Another major challenge related to that is that studies are seldom co-designed with patients. During the co-design process, patients can provide input as to what will work and what won’t, identifying logistical problems in the proposed study protocol and letting you know what’s truly feasible. For example, you can ask patients if the number of times they would be expected to visit the hospital is possible, rather than assuming that it will be. If sponsors involve patients in study planning early on, they can significantly improve patient recruitment.
Chris: Agreed. I’ll also add that recruiting a diverse set of patients to a study is another challenge. Often the hospital sites themselves have plenty of diversity in their base patient population. But it’s a mistake to expect the study team to be responsible for diversity in recruitment. While one approach can be to collaborate with the study site to access the hospital’s patient population, you should also ask yourself, what other strategies can we develop to boost diversity?
If a sponsor or a CRO is failing to meet their patient recruitment goals, what are the most common errors they tend to make when trying to catch up?
Chris: Operationally, I have seen that a sponsor or CRO often selects one strategy to boost recruitment, and then waits to see if that strategy will work. The problem with that is, six months will pass and if that strategy wasn’t successful, they’ve delayed their timeline, wasted money, and have not solved the problem. In fact, you probably have to execute on 20 different strategies simultaneously, and continuously assess them and re-evaluate if needed.
Annabel: As a consequence of relying on just one recruitment strategy, sponsors often seek consulting support in recruiting patients through patient engagement at a point that is late in their planned timeline. Rather than taking a “wait and see” approach, you’ll be much more successful if, early in the process, you involve the patient perspective in a thoughtful, multi-pronged recruitment strategy.
Chris: Another issue is that the sponsor often considers enrollment the responsibility of the principal investigator (PI) and the study team at the hospital. This situation results in frustration on all sides. The study team doesn’t have the time or bandwidth because they’re running multiple studies and have numerous responsibilities. Don’t expect the study team to solve recruitment for you. Certainly, one of your strategies can be to talk to the investigator, but you need to find a way to support them and work collaboratively.
Annabel: There’s a whole world outside the site that most sponsors don’t consider, in which so many potential recruitment strategies can be put in place. Sometimes limited budgets and lack of knowledge of other options, can make them think they should stick to traditional approaches, such as relying on the PI, but what’s been done for years doesn’t necessarily work anymore. And PIs are concentrating on the investigation and they simply cannot handle everything. So I think that sponsors should think a little bit outside of the box, and consider strategies that may take them beyond their comfort zone.
Chris: A patient concierge service can make a big impact here. Rather than sending an email to the site and saying, “Hello busy PI, here’s the name and the phone number of a potential patient for our study, now you reach out,” if we can add an additional person to the clinical team who calls the patient, walks through the pre-screen process, reviews key items, and then liaises with the site while offering to facilitate further patient communication, that is a path to success.
How is the evolution of technology improving patient recruitment?
Annabel: Digital advertising allows us to reach out to potential targets for study participation. We use display ads to mobilize patients to a landing page where we explain the benefit of the study and the type of person who would be perfect for this study. People register themselves as a potential participant and then we share more information with them. This technology allows us to cast a wide net for finding patients, while also enabling a seamless experience in the background to capture patient information, connect patients with the PI, and communicate with them going forward. This is, of course, combined with off-line techniques, such as engaging with patient associations.
Chris: The other way technology impacts recruitment is by making studies more feasible for patients. Sometimes this means using wearable devices or self-administering medicines in the home. If you can tell a potential patient that instead of having to go to the hospital site eight times in four weeks, they only have to go twice because you can collect their data remotely, that can make a major difference in whether that person can participate. If you design a flexible protocol that lets you leverage technology in this way, you can expand your patient pool.
What is the most effective way to leverage technology for recruitment?
Chris: Technology alone won’t enroll patients in clinical studies; it’s an enabler which you can combine with clinical expertise and patient engagement to succeed in recruitment. You need deep knowledge and experience to make technology beneficial, and you must include the human component. I’ve seen companies fail when they relied totally on technology and left out the human interaction, especially when it comes to not just finding patients but convincing them to participate. For example, we were running a study in an older population living with diabetes, and because digital technology was the only option for participation, these patients felt they couldn’t be a part of the study because they didn’t have smartphones.
The human touch can make people feel better about why they should join a study and how they can participate in a way that meets their reality.
Annabel: We also use a combined technology and human approach to retention, which is the next phase of recruitment. The human component there is understanding and communicating with patients to keep them participating in the study, while technology such as our Health Storylines™ platform supports patients throughout the study.
What are your three recommendations for those who want to boost their study recruitment?
Chris: First, you should use a multi-pronged strategy that involves each of the different stakeholders. Never take just one approach to recruitment.
Annabel: The second is to consider the patient in the design of the recruitment plan; you can even co-create the recruitment plan with patients.
The third key recommendation has to do with time. Don’t start too late!
Chris: That’s a great point. Start early! Build in defined time points and risk mitigation right from the beginning of the project, and anticipate recruitment issues because no matter what, it’s not going to be easy. You can’t just set a target metric and then come back six months, twelve months, even 24 months later to find that you are way behind.
Annabel: These delays can result in having to resubmit protocols, which costs still more time and money. It’s not just that you’re losing the opportunity for recruitment; the consequences to your company can be enormous.
To conclude, we recommend that you collaborate with your PI and study team, but don’t expect them to meet your recruitment goals for you. You need a powerful recruitment strategy, developed early on and created with patient input, which includes a wide range of patient engagement approaches and leverages technology to attract study participants. You’ll not only meet your recruitment goals but also avoid delays on your journey to the marketplace.