Becoming a clinical trial investigator: what physicians should know

Many physicians consider moving from referring patients into research to running studies themselves, either as a principal investigator at their own practice or by partnering with an established research site. It can be professionally rewarding and commercially viable, but it is a genuine operational commitment, and understanding what is involved before you start is the difference between a sustainable research arm and an abandoned one.

The formal requirements are the easier part. Investigators need training in Good Clinical Practice, the international ethical and scientific standard for trials involving people, which is available through short accredited courses. Sponsors will also assess your qualifications, your access to the relevant patient population and your facility. As principal investigator you carry legal responsibility for the conduct of the study and the safety of participants at your site, a responsibility you can delegate tasks under but never delegate away.

The operational requirements are what surprise most newcomers. Trials demand infrastructure: secure document and drug storage, calibrated equipment, often a refrigerated centrifuge and a freezer for samples, and reliable processes for data entry, adverse event reporting and hosting monitoring visits. Above all they demand coordinator time. A study coordinator, even part time, is close to essential, because protocol administration cannot be absorbed into normal consulting hours.

Sponsors select sites largely on two things: access to eligible patients and a track record of enrolling them. A first-time investigator has no track record, so your patient population is your main asset. Practices with large, well-characterised populations in a specific therapeutic area, such as diabetes, dermatology or cardiology, are considerably more attractive to sponsors than generalist practices of the same size.

For many physicians, partnering is a better first step than building. Options include becoming a sub-investigator on studies at an established site, joining a site network that provides the infrastructure, coordinators and sponsor relationships while you provide clinical oversight and patients, or simply becoming a reliable referral source for local research sites while you learn how studies run. Each of these builds experience and relationships without the upfront investment of an independent site.

Whichever route you take, recruitment will decide your success, because sponsors judge sites almost entirely on enrolment. Clinrol works with research sites on exactly that problem, and our healthcare professionals page is a good place to start a conversation, whether you want to refer patients today or explore what running studies could look like for your practice.