CTTI Suggests Ways To Reduce “One And Done” Clinical Investigators

About half of the physicians who participate in clinical trials do only one trial, never doing another one. About half of the investigators in clinical trials are new, doing their first, and possibly last, clinical trial. Doctors do not do second trials because of the extra work and time needed to conduct a trial and to negotiate the budget. Clinical Trials Transformation Initiative (CTTI), a joint venture between Duke University and FDA, conducted an FDA-funded survey to understand the reasons for these “One and Done” investigators and suggest ways to reduce them. Sponsors spend significant resources to find qualified investigators for their clinical trial and training them. The first trial also takes a lot of resources, patience and training for a physician. If a physician builds positive experience with the clinical trials, subsequent trials are easier. The quality of the trial conduct also improves with the involvement of experienced physicians. It’s ironic that while clinical trials offer increased financial rewards, higher credibility with patients, and professional recognition opportunities, physicians leave the clinical trial enterprise primarily due to lack of perceived support from sponsors. It is generally believed that sponsors limit training to a specific trial and do not provide long term support. Also, once recruited on a study, the physicians are expected to build their teams, self-train their personnel, pay for compliance, and do the extra work without additional compensation. CTTI recommends addressing all these issues to build long-term sites and high quality trials. CTTI recommends that sponsors help a clinic build a multi-dimensional team to cover all skills needed to support a trial, provide continuous training, and create SOPs. Sponsors should further recognize and acknowledge good investigators and site personnel, and engage with investigators in a continuous manner. It is further recommended that sponsors create “enrollable” trials, site be matched diligently to trials, and follow good subject recruitment practices. The clinics should carefully calculate budgets for all contracted tasks, assure that the contracts are well written and cash-flow concerns are addressed early one and constantly. All these recommendations sound good but are not new or surprising. Most experienced sponsors and CROs should be aware of these measures and hopefully be already implementing these. The recommendations do not provide specifics but are very generalized, possibly to create a broad overview for most trials. For example there is no discussion of the use of social media for recruitment, and Sunshine Act concerns. These recommendations will likely carry some weight with academic sites and new clinics due to the source of the information. Overall, these recommendations are a reasonable summary of generally acceptable measures and should be a good start for new sponsors and CROs. It’s hard to know the overall impact of these on the conduct of clinical trials.