When we surveyed U.S. industry executives and site study staff, we found that coordinators play the most significant role in study recruitment, data quality, meeting timelines, and providing continuity for study subjects. The survey responses from study subjects, however, may surprise you.

When subjects were asked, “What would you like to see done differently if you had the opportunity to be in another clinical study?” the response was almost universal. Subjects responded that they wanted to see the doctor more often at their study visits. Many reported that they never saw the study physician.

This finding prompted us to look even more closely into the relationship between PIs and study subjects. Over the past several years, we have questioned over 500 study coordinators about their PI’s involvement in clinical studies. Coordinator responses confirmed what subjects had reported: a “practically invisible” or “partially involved” PI. In fact, the results were staggering. They showed that only 5% of physicians routinely saw subjects during their study visits.

You may well feel that it is unnecessary for the physician to be present at every study visit. Perhaps the specifications of your respective protocols do not require it, or a study visit with limited procedures—such as labs tests and blood draws—makes the role of the physician negligible. Nevertheless, that is not what patients enrolling in clinical studies expect.

Unlike those of us involved in clinical research, most patients do not distinguish the difference between clinical care and clinical research. Patients who visit a clinic for a routine medical check-up or a sick-patient visit are used to seeing the doctor, so it is no wonder that the majority of patients who enroll in clinical studies count on seeing a physician at each visit—or at least most visits. That is part of the way subjects assess the quality of care they receive during a clinical trial. Practically invisible clinical investigators can significantly affect whether subjects remain enrolled in a study—or sign up for another.

Until recently, many pharmaceutical sponsors have taken a hands-off approach when it comes to requiring (or even encouraging) physicians selected as principal investigators to see study subjects. But this is changing. Some clinical teams are proactively planning and implementing recruitment and retention programs simultaneously. This makes sense for several reasons:

• Recruitment is often more challenging than retention.
• Recruiting subjects can cost three to five times as much as retaining them.
• Sustaining subjects’ interest in a study means that sponsors can get data for the required number of evaluable subjects more quickly, because fewer subjects must be enrolled.

Subject-directed retention programs, staff training that focuses on subjects’ expectations and concerns, and the collection of subject experience metrics are some of the initiatives that can be implemented to address the consequences for study success of partially involved PIs.

Sponsors can and should play a significant role in establishing SOPs (standard operating procedures) that require PI involvement. Subjects expect it. There’s no reason for sponsors to expect less.

Elizabeth Moench is president of MediciGroup, 1012 West 8th Ave., Ste. A, King of Prussia, PA 19406, (610) 337-8330 ext. 228, fax (610) 337-4233, email: emoench@medicigroup.com.