Long ago, in a land far away, principal investigators were expected to “accrue study subjects” using their network of physician colleagues. Enrolling subjects from one’s patient panel was discouraged as therapeutic misconception might impugn study results. As a result, acceptable enrollment might run from 36 to 60 months or more.
Investigators would commonly send a “Dear Doctor” letter to others within their hospital or to their personal connections. Rarely did these letters produce effective results. Over time, referring physician programs altogether lost value and credibility due to a few commonly held beliefs:
- Administrative personnel open and discard these letters without ever showing them to the physicians in their office.
- Doctors don’t have email addresses and those that do, don’t have time to read them.
- Doctors won’t refer patients to clinical research sites for fear of losing revenue from that patient’s care.
- Physicians have neither the time nor interest in exploring investigational treatments.
- Physicians won’t refer patients to clinical studies unless they are paid for the referral.
Enterprising researchers took a more comprehensive approach by hosting lunch or dinner meetings to brief colleagues on active studies, or participated in Grand Rounds programs. Study sponsors often supported these programs through underwriting the costs and providing key opinion leaders as guest speakers. Some paid referring physicians for their efforts.
Eventually, market pressures drove other changes that further challenged referring physician programs.
- Industry sponsors could no longer accept long enrollment timelines and risk first-to-market status for first-in-class therapies.
- If investigators in the US and Western Europe couldn’t enroll faster, then investigators in Central and Eastern Europe, Latin America and Asia Pacific should supplement them.
- Media exposés shed light on various aspects of clinical research resulting in some policy changes such as the Sunshine Act requiring reporting of financial relationships between industry and physicians.
Just when it seemed as if the door was firmly closed on referring physicians as valuable collaborators in clinical research, science and technology stepped in and contested that assumption.
In Part 2 of this series on Research Champions we will let referring physicians speak for themselves and share the results of BBK’s third annual survey on clinical trial referrals.