May 1, 2017 – Keeping site investigators engaged is crucial to the future of large trials, according to two DCRI researchers.
The DCRI’s Robert Mentz, MD (pictured), and Eric Peterson, MD, MPH, have outlined some of the challenges and responsibilities facing principal investigators (PIs) of multi-site clinical trials in a new editorial published in Circulation.
As clinical trials have changed in recent years, the responsibilities of site PIs have grown in both number and complexity. These responsibilities typically include managing the trial’s conduct, maintaining adherence to regulatory requirements, and ensuring the integrity of the study data. A consequence of this workload is that many site PIs often grow dissatisfied with the process and less interested in trial participation.
The two DCRI authors suggest several methods to help improve the satisfaction and recognition of site PIs. One such method is the use of an algorithmic approach to authorship in trial-related publications based on specific metrics to ensure more equitable recognition for trial efforts. Another option is the use of letters of accomplishment to a site PI’s supervisors from the trial’s leadership. The most effective inducement to site PIs, however, may be increased financial compensation.
“The role of financial incentives in practice is likely dependent on the incentive amount relative to overall compensation,” Mentz and Peterson write. “In regions where physician salaries are lower, even a more modest incentive may be important. In the United States, investigators are often paid more than site investigators from other countries despite lower enrollment per site. As such, in many large groups, these financial contributions can help recognize individual site PI time and effort.”