25 Reasons People Aren’t Enrolling in Your Clinical Trial
We’ve long heard about the lack of participation in clinical trials and how slow poor enrollment dogs many, if not most, clinical trials today. What follows are the 25 most common reasons people choose not to participate in clinical trials. These reasons represent some of the issues we will need to address if we want to increase participation and speed up time-to-market.
1. Lack of awareness. Quite simply, people just don’t know what clinical trials are and don’t understand the importance of them. This is one of the most widespread challenges that we as an industry need to solve. (Read about how we recently teamed up with industry organizations to do just that.)
2. They don’t meet the requirements. Most trials have strict requirements about other conditions, medications, etc. that may prevent interested individuals from joining.
3. Fear. People are instinctively afraid of the unknown. Patients may be are unsure what to expect from a clinical trial, and might be worried that their health may actually suffer from participation.
4. Too much travel. It could be the case that an individual is more than willing to participate, but that the nearest site is a 2- to 3-hour commute, and they either don’t want to or are unable to make that journey.
5. Fear of placebo. The majority of the general public doesn’t understand the different phases of clinical trials and could be under the impression that all clinical trials have a placebo. It is likely that if they are going to participate, they want to make sure they are getting the new drug. What they probably don’t realize is that in most trials (except Phase 1, where healthy volunteers are used to test dosage levels) the alternative to the new drug is actually the current recognized standard of treatment.
6. Distrust of “Big Pharma”. Some feel that the drug companies only see clinical trial participants as subjects or numbers, and that they are worried only about future profits and bottom lines. They feel researchers are wrongly motivated, and are weary of placing their lives in the hands of the industy.
7. “Guinea Pig”. Nobody wants to be experimented on “just to see what happens”, yet, that is unfortunately a common perspective of clinical trials.
8. Doctor is not aware. Doctors need to be aware of any trials that may be applicable to their patients.
9. Doctor isn’t interested in participating. Even if they are aware of current trials, some doctors are not willing to participate because of the time, staff, and resources their participation would require.
10. They were never asked. People can’t participate in a trial if it is not offered to them. Doctors must be willing to actively share and discuss available trials with their patients.
11. Lack of assurance. When evaluating different treatment options, patients want to be told that the proposed treatment is the best possible one for their current condition, and not that it simple “may or may not work.”
12. Safety. People have become accustomed to hearing the multitude of possible side effects in drug advertisements for approved drugs. As a result, they may think the worst when it comes to drugs or therapies that are not yet approved for market.
13. Not terminal. A lot of people believe that clinical trials are a last resort, and that you have to be terminal to participate in one. The reality is that there are many clinical trials available to patients at all stages of diseases.
14. Costly. People question who will pay for their participation and fear that the insurance company will not cover the cost of a new or experimental treatment.
15. Afraid of opt-out consequences. Some people fear that if they join a clinical trial and later decide to opt out of it, they will receive a lesser standard of care from their doctor.
16. Lack of patient centricity. Participants should be made to feel that they are being cared for and listened to, and not just being experimented on. They want to feel that their experiences and opinions will matter to the doctors and the outcome of the research, and they often are afraid that this will not be the case.
17. Bias horror stories. We’ve all seen or heard stories about an unethical person or company skewing research results for a desired outcome. This undoubtedly turns people off because it leads them to assume that the outcome of a clinical trial is predetermined, regardless of patient experience.
18. Lack of follow up. It is very rare for researchers to follow-up with the patients after a study to share the results. People likely want to know that their contributions to the research mattered.
19. Not a good match. Occasionally, when a patient is offered a clinical trial, it is for a therapy that offers little for the specifics of their condition. While the trial may seem to be a good fit initially, the specifics of the treatment or disease that the trial Is targeting may not be a match to the patient’s condition.
20. More tests. People often think that participation in a clinical trial means that they will have to undergo many rounds of testing and are reluctant to more “poking and prodding”.
21. Receiving effective treatment. If a patient’s current treatment appears to be delivering positive results, they will most likely be hesitant to switch to an unproven alternative.
22. Healthy. Individuals who are free of disease and otherwise “healthy”, often do not even consider the possibility of participating in clinical trials.
23. Time requirements. Some individuals elect not to participate in clinical trials because doing so would take up more of their time, whether it be in the form of additional physician visits, increased drive time to the study site, or time spent recording personal data at home.
24. Unsupportive family. Family and peer pressure is a powerful thing. If family and friends have negative attitudes about, or are otherwise against an individual participating in a trial, there is a good chance they won’t.
25. Overly stringent protocol. We all like things to be easy and simple. A trial protocol that asks patients to record too many vitals, too often, or has a plethora of unnecessary office visits will likely face enrollment challenges.
We are currently working on an ebook to examine some of the most common challenges that sites face. We’ll also be providing an in-depth look at 6 practical solutions that will boost your enrollment levels in no time! Make sure you subscribe to our blog to be notified of its release!
What are your thoughts? Are there any other reasons why someone might not participate in a clinical trial? What are some things that need to happen in order to boost participation?