You’ve gone through the recruitment process with a patient for your clinical trial — now you’re waiting for them at the clinic for screening.
The appointment time comes and goes. You wait ten minutes, then twenty.
The promising candidate has become a no-show, and you’re left with one less participant for your study. After all that work.
While no-shows are certainly a major issue, it’s difficult to narrow the challenges in clinical trial recruitment and retention down to just one. With so many barriers to effective recruitment and successful retention, it’s critical to know the best practices to meet your goal.
Barriers to success in clinical trial recruitment and retention include issues with patients, problems with your own processes, challenges with the study itself, and external factors like misconceptions about clinical trials on the whole.
Our Due Diligence process will help you understand the challenges ahead, whether internal or external, building a clear picture of what’s to come before you begin. You can request one at no cost here.
Just as there are multiple barriers, there are also multiple factors for success in patient recruitment and retention. Read on for solutions to some of the biggest challenges — and what we’ve found to be the biggest success factor in recruiting for clinical trials.
Frustrations of Clinical Trials Recruitment and Retention
With a myriad of challenges, it can be difficult to narrow them down into a concrete list. But these are some of the most common in recruitment and retention that research teams face.
- Finding eligible patients in the first place.
- Patients unable to commit time to the clinical trial.
- Candidates are concerned about the risk of the study.
- Interested patients are too far from the clinical site or lack transportation.
- Researchers are running competing study protocols — multiple clinical studies in the same area are recruiting similar patients.
- Recruiting for clinical trials with invasive or unpleasant procedures, or with low compensation, can be difficult.
- Patients refuse to participate due to concerns with how the information will be used.
- Candidates sign up for the study but then don’t show up to the first visit.
- Patients realize the study will take up too much of their free time.
- After beginning, participants don’t see the benefit of the study.
- Patients lose interest over time.
- External factors cause climbing dropout rates, like moving out of the area or experiencing health difficulties.
- Patients don’t have the social support they need to continue participating in the study.
- Participants don’t feel valued as a critical part of the clinical trial; instead, they feel more like a cog in a machine.
Obstacles in recruitment are aligned with finding interested patients and addressing their concerns. And in retention, they have more to do with expectations, interest and time.
Meet the Challenges Head On
Whether it’s no-shows during recruitment or dropouts during retention, the bottom line is: participants are under no obligation to complete a study.
And fortunately or not, their level of engagement and feelings of value throughout is up to you.
In recruitment, the key is to enroll people who are invested. And in retention, you must keep them invested and interested. Here are the major success factors that contribute to this goal.
Factor #1: Maintaining Good Communication Through Recruitment and Participation
Good communication is foundational to trust, value, expectations, and simplified processes — all the other success factors we discuss below.
For clinical trials, communication with candidates and participants begins with initial outreach efforts and doesn’t end until the pharma study has successfully concluded.
From the very start, think about how you want to effectively communicate with candidates for the study. And to help you maintain excellent communication throughout, take the time to answer these questions:
- What can you include in the brochures you leave in physicians’ offices that will best encapsulate what your study is about? What about the bigger picture?
- What questions about your study can you anticipate so you’re ready with an answer? Can you create a phone and email script so communication remains consistent and clear?
- How can you maintain communication with participants between clinic visits to ensure they remain interested?
- What is the best way to make sure no one falls through the cracks with your calls, emails and in-person communication?
- How can you add a personal touch to patient communication? (Think personalized visit reminders and birthday cards)
Factor #2: Building Trust With Candidates and Participants
Communication is the starting point of a relationship, but you can cultivate this further by consciously building trust with candidates ahead of the study and with participants during the study.
As a starting point, make it a priority to provide a comfortable and patient-friendly environment for your clinical trial. For remote clinical sites, and depending on the target population, take cultural and language differences into account so patients feel at ease for better engagement.
Beyond this, consider implementing some of these strategies to build trust in your clinical trial:
- Involve physicians whenever possible; they can speak to candidate doubts and better convey the study’s benefits to participants.
- Promise and ensure the protection of patient information, making it clear that this is a priority for your entire staff (as long as it is!).
- Accommodate patient schedules and transport needs whenever possible.
- Make space and time at every turn to answer patient questions and concerns with care — from initial phone screening to the final clinical visit.
Factor #3: Establishing the Value of the Clinical Trial — and the Patient
You can set up effective communication strategies and focus on building patient trust, but most clinical trial participants won’t stick around if they don’t see the value of the study, or feel valued.
In some cases, this translates into direct monetary compensation: they give you their time, and you give them a few hundred dollars for their participation. But this isn’t the only form of value.
Benefit to self: How will the clinical trial benefit the patient beyond the study itself? Could it help move their treatment forward, or give them a better understanding about their condition?
Benefit to others: Take the time to explain how the clinical trial will help an entire group of people. How will the results help physicians treat similar patients in the future?
The importance of value goes the other way also. Throughout the study, it’s critical to show appreciation and recognition for patients. Make them feel like an important part of your clinical research at every turn — because they are.
Factor #4: Setting and Meeting Participant Expectations
Set up clear expectations for patients from the very first contact onward. For those considering the study, make sure they have a good understanding of the requirements and time commitment well in advance.
Be upfront about how the results will be used, what kind of paperwork they will have to fill out, and what kind of communication they can expect from you. Get detailed about what their consent involves.
Simultaneously, take the time to address any misconceptions about clinical trials in general or your study in particular — especially if it involves invasive or uncomfortable procedures.
From there, make sure you meet those expectations. Surprising patients with complicated steps (like a consent form you haven’t walked them through) ahead of their first visit is a good way to get patients to drop out of the study. And, not following up when you promised to may quickly lead to an erosion of trust.
Factor #5: Creating Simple Processes for Participation
Even with the best of intentions, it can be difficult to keep up with each of the success factors above once a clinical trial gets underway.
To avoid getting overwhelmed and overwhelming your patients, design a recruitment, assessment and participation process that’s easy for both of you.
For example, design assessment and consent paperwork that’s simple for patients to access, complete and submit. For your part, get organized ahead of time with a candidate tracking spreadsheet and scheduling process before queries start to roll in.
Using an electronic enrollment process — with an online prescreening questionnaire, phone scheduling and materials — is a good way to simplify things for everyone.
The Most Important Success Factor: Maintaining a Relationship With Participants
From maintaining good communication and building trust, to creating simple processes for participation, all of the success factors above come back to one thing: committing to a relationship with candidates and participants alike.
From our experience, the volunteer-researcher relationship is the most important success factor in clinical trial recruitment and retention. Whether you are setting up a prescreening phone call or answering questions during a clinic visit, what you do should have an underlying focus on creating and maintaining that relationship.
A focus on building the relationship during the recruitment stage will translate into better marketing materials, phone calls and candidates. At the same time, solving retention issues is about staying organized throughout the study — but again, it’s about maintaining this connection with your participants. Both will complement your efforts and help achieve your final goal of having the maximum number of participants complete the study.
Patients are at the heart of clinical trials, after all. While it’s tempting to focus on the research alone, it’s the relationship you have (or don’t have) with your trial participants that will make the biggest difference in the end.