Principal investigators (PIs) frequently assume patients are unable or unwilling to take part in a clinical trial, limiting enrollment efforts, according to ZS’ 2021 U.S. Voice of Site/Voice of Patient survey.

The survey, which questioned 200 patients (including 83 who came from underrepresented populations), found that PIs greatly underestimate patient willingness to participate in trials.

Of the patients PIs assumed to be eligible for trials, 56 percent were not in fact offered the opportunity, while 55 percent of patients offered the chance to join a trial were expected to say no, according to the PIs who participated in the survey.

The top reasons PIs did not mention clinical trials to patients were: concerns about patient compliance with scheduled assessments based on their history of physician visits; patients being well-managed on their current treatment(s); concerns about drug regimen compliance based on history of treatment adherence in the past; concerns about patients being able to reliably make it to the site; and belief that patients don’t have the health literacy or understanding needed to grasp what’s required for informed participation.

Of the patient respondents, which were a combination of those with trial experience and those who had never participated, a majority — 75 percent — said they would likely consider a clinical trial if a doctor recommended it. This was also the case for 77 percent of underrepresented patients.

In addition, the survey revealed that sites say that recruitment and referral, training and contract negotiations are the most important areas for sponsors to improve upon.

Of the more than 150 principal investigators and nearly 80 research coordinators that responded, nearly half (48 percent) believe that patient recruitment and referral require the most support from sponsors, making this the number one trial element in need of improvement.

Enrollment is frequently a struggle area for sites, and 50 percent of sites will enroll no more than a single patient, with many enrolling none at all, according to Sharon Karlsberg, principal at ZS, a consulting firm that specializes in clinical trial research.

Coming in second on areas needing improvement, 46 percent of PIs and coordinators named training and other learning opportunities, while negotiating and signing contracts with sponsors came in third, with 45 percent of the respondents citing it as an area in need of improvement.

Access ZS’ survey presentation here: https://bit.ly/3hbpjxj.