Low recruitment rates have been attributed as a main cause for clinical trial failures, but what should be held accountable for low recruitment rates? A report by the Tufts University says it’s poor physician and nurse engagement.
About two-thirds of clinical studies didn’t meet patient enrollment goals, said a 2011 report by the recent Tufts Center for the Study of Drug Development. A recent report prepared by the same institution based on 2,000 physicians and nurses mostly based in the U.S. and Europe broke some misperception long held by the industry about the reason. One of them is that low referral rates of patients into clinical trials are mainly caused by physicians’ lack of familiarity and low comfort level in doing so. But the report shows quite the opposite.
The study found that nearly all physicians, or 91%, and 72% nurses feel, at least to some extent, comfortable discussing the opportunity to participate in a clinical trial with their patients. But the actual 0.2% referral rate from physicians is nothing but perplexing.
However, it might be important to separate physicians who routinely participate in clinical trials from those who don’t, said John Lewis, SVP of policy and public affairs at Association of Clinical Research Organizations. According to the Tufts study, physicians in clinical practice are about three times more likely to refer their patients into clinical trials than those in hospital-based settings.
Physicians and nurses are saying, through the survey, that they’re unable to access related trial information, that the information is insufficient, and that they are not given enough turnaround time to refer patients.
Besides limitations of manpower at CROs and their sponsors, clinicaltrials.gov has not exactly been utilized in full. It’s been criticized as hard to navigate, and that contributes to insufficient access to information on trials, said Lewis, and he sees making improvements to the official trial database as mandated in the 21st Century Cures Act “as addressing a major barrier to information flow regarding clinical trials.” Lewis said ACRO’s vision is to see clinicaltrials.gov integrated with electronic health records, so matched trials could be flagged as a “pop up.”
But patients might not need to get trial information from physicians anyway as more recruitments are being done through patient communities and even social media. “There is definitely some movement from the traditional model of all recruitment funneling through the physician investigator to a more patient-direct, and patient-driven approach,” he said, a recent development that’s gaining pace but has not been fully captured in the Tufts report.