How to address barriers to clinical trial patient recruitment [update]
[Updated June 2019]
We often talk about the benefits of participating in clinical trials: patients gain access to the latest therapies in development; they contribute to future treatments and cures; and they receive personalized and attentive care. And yet, 80% of clinical trials continue to close or be delayed due to difficulty finding patients to take part.
Our most recent whitepaper, Patients Have a Type, took a close look at findings from a survey of 4,000 patients that we conducted with SCORR Marketing and eight of our advocacy partners. It found that patients are actually interested in research - they just need to be approached in the right way, based on their lived experiences, including elements like their condition and their race.
Here, we’ll examine the barriers to participation and what researchers can do to address them as part of clinical trial patient recruitment:
One of the greatest barriers to patient participation are widespread misconceptions and myths about what it means to be in a clinical trial. Those involved with research can play an important role in clearing up these myths by addressing them directly in recruitment materials and during initial conversations with potential participants. Here are some patient-friendly messages you can use to help clear up these misconceptions in these communications:
Myth: Clinical trials are a last resort
Suggested Message Yes, many patients, and even doctors don’t look to clinical trials until all other treatment options have been tried. But the fact of the matter is that there are clinical trials available for all stages of disease — some are looking for newly diagnosed patients or patients who have not yet tried any treatment. What’s most important is considering whether the potential benefits of a trial would outweigh the risk at whatever stage of disease the patient is in.
Myth: Patients in clinical trials are treated as guinea pigs
Suggested Message: The truth is that most often, patients are joining Phase 3 trials (patient-friendly explanations of the phases of clinical trials here). By this point, trials have gone through Phase 1 to test safety and Phase 2 to test efficacy. Patients concerned with being a “guinea pig” should definitely consider trial phases as they search for a match.
As far as the quality of care goes, clinical trial participants often receive more time and specialized care than they do from their regular doctors. Researchers working on clinical trials tend to be leaders in their field, as well.
Myth: Patients aren’t told the results of a clinical trial
Suggested Message: All trials must submit results to clinicaltrials.gov. But, because that website is often difficult to navigate, researchers should share when and where the results will be published as part of the informed consent process.
Myth: Patients have to stop the study drug once the clinical trial is complete
Suggested Message: Often, if the treatment being studied is working well, patients are able to stay on the drug once the trial is complete. Patients can ask about this as part of the informed consent process so there are no surprises at the end of the trial.
Myth: There’s a good chance a patient will get a placebo
Suggested Message: While yes, some studies do use placebos, for studies in life-threatening or serious conditions, a placebo would rarely be used. For example, in cancer trials, the control arm is most often current standard of care. Other trials may measure the effectiveness of an existing treatment against a potential new one. Some trials may also have a placebo phase of a trial, but offer the treatment to all patients later on, or switch participants in the placebo and active arms of the trial.
Often, patients don’t take part in clinical trials for logistical reasons. If a trial is not convenient — if it requires too many visits, or too much record-keeping, or if the site is too far away, for example — the benefits are unlikely to outweigh the inconvenience for patients. Patients are also unlikely to enroll in a trial that asks too much of them physically. In an upcoming whitepaper that dives even deeper into our 4,000-person survey, we’ll touch on how these logistical issues are different based on a patient’s experiences. For example, socioeconomic factors like education and income impact what’s most important from a logistical perspective.
This is where trial design becomes very important. In our blog post about designing patient-centric trials, and our top piece of advice was simple: talk to patients! Patients are often happy to serve as a resource if it improves the research being done in their condition.
Along with logistics, cost can play a large role in whether or not a patient takes part in a trial. While patients do not typically have to pay to be in a trial, they do have to pay to travel to the trial and take time off to attend study visits. To encourage more participation in trials, reasonable financial compensation should be offered for time and travel, and this should be made clear in recruitment materials and during the informed consent process. Our survey results showed that not needing to take time off, and being paid or reimbursed for time and travel was especially important for those with chronic illness. The process for providing this compensation should also be discussed during the informed consent process — and it should be organized and efficient.
Antidote can help you address these barriers. To learn about the work we’re doing to drive awareness and improve clinical trial patient recruitment, get in touch today.