Study Tries to Explain Poor Patient Recruitment Rates
[Thursday, February 21, 2019] Patient recruitment issues afflict all clinical trials and a recent study shows that the main reason for such performance is not the availability of enough participants but the trial design. More than two-thirds of the participants either do not find trials or do not meet the strict inclusion criteria. Another 15 percent are not enrolled by the investigators for some reason, leaving only one in ten participants enrolling in a given trial. Although the review only looked at a few trials in oncology and it could be argued that the data was insufficient to extrapolate to all clinical trials, the observations seem logical. In diseases well managed by standard of care, patients do not want to enroll in me-too treatments that offer insignificant benefits. It was found that in oncology, almost half the patients did not enroll in trials because they had cancers treatable by available therapies. Only patients who failed their first treatment were willing to participate in trials. This is true for patient populations in all diseases. Similarly, a significant percent of potential participants either did not know about trials they could participate in or the trials were not available near them making it a logistical and financial challenge to participate. Most patients found the cost of traveling to a remote clinical site or the time commitment needed to participate overbearing. The physicians treating patients are the most common sources of information about potential clinical trials to them, and since only about 12-15% doctors are also investigators in trials, most patients must change clinics to participate in trials. The solutions to these issues are to encourage more doctors to participate in trials and matching patients to clinics closer to them. Trials that use online tools to reduce patient visits, offer home visits, and collect data remotely using wearable devices would also encourage more patients to participate. Most trials start with very restrictive inclusion criteria and then must amend the criteria to reduce rejection of patients losing time and adding to the cost of the trial. Trials should be designed with reasonable inclusion criteria developed in consultation with physicians who can advise about ones that are practical and clinically relevant. Once these issues are addressed, it should allow the almost 75% patients who are lost in the process currently, to find trials for mutual beneficence of the sponsors and patients.
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