Patient recruitment - continued
Barry Bertolet, M.D., F.A.C.C., an interventional cardiologist with Cardiology Associates of North Mississippi (CANM) says that for most patients, the recommendation and approval of their physician is a critical factor in the decision about whether or not to participate in a clinical study. But other trusted caregivers can be equally effective, he says.
“We have found that nurses can be extremely effective at helping us recruit qualified patients,” he said. “For cardiology studies, we sometimes have a very short window of opportunity for recruitment, and hospital or lab nurses are a great source of referrals.” In fact, says Dr. Bertolet, “100% of our patients today come from our nurse referral program.” “By U.S. law, a physician cannot receive payments for enrolling patients,” said Dr. Bertolet, “but referral fees for nurses are legally permitted.” He adds that since his practice instituted the referral program, “our recruitment numbers have shot way up.”
“By U.S. law, a physician cannot receive payments for enrolling patients,” said Dr. Bertolet, “but referral fees for nurses are legally permitted.” He adds that since his practice instituted the referral program, “our recruitment numbers have shot way up.”
“Unrealistic” protocols pose challenges
Drs. Pergola and Bertolet agree that, from an investigator’s perspective, unrealistic protocols are the leading cause of enrolment delays and retention problems.
“Even though many individuals at pharmaceutical companies and CROs know what field work is like, there is still a disconnect when it comes to writing protocols,” Dr. Pergola says. “So many protocols are simply not based in reality,” he continues, “so we lose a lot of suitable patients willing to participate in studies.”
Dr. Bertolet agrees. “Exclusion and inclusion criteria are major problem areas. In my view, they’re often much more narrowly defined than they need to be.”
Dr. Bertolet also believes that many protocols are simply too demanding of patients. “There’s a disconnect with what real human beings are willing to do,” he says. “Some of the demands on patients are so onerous that it becomes almost impossible to recruit for certain studies. For instance, take a patient having to inject himself with a saline placebo twice a week for two years and visit the clinic once a week as well—couldn’t the protocol be modified to be less demanding?
“In my experience, patients are very willing to participate in research. Many of them have a sincere desire to help science. Others may like the idea of having access to medicines not yet available. But they’re not going to put their lives on hold for a clinical study.”