I believe that game-changing gains in clinical trial efficiency will be realized only through transparency – specifically the ability of any party involved in a trial to objectively understand trial progress (as allowed by trial design), their own performance (and that of their peers), and collaborate to complete their responsibilities. In a recent PLoS article, I found an international group of researchers who seem to agree:
We believe in the benefits of increased transparency in all phases of clinical research, since it has been proven not only to build trust, but also to be one of the best tools to reduct bias, to improve credibility of the results, and to foster the efficient management of trials.
The particular focus of the article was subject recruitment, and the proposal made by the authors was simple and potentially powerful:
We believe that recruiting sites’ principal investigators should be accountable for the conduct and outcome of their trial… Hence we propose not only to disclose the names, contact details… but also to reveal their recruitment commitment and the number of recruited participants.
Imagine – on a visit to clinicaltrials.gov, or any other trials registry, that one would see for each site on a trial the planned and actual patient recruitment numbers. Having these data available to and consumable by the public would emphasize accountability while reaping benefits such as:
- Providing an additional measure of principal investigator performance to other parties involved in the trial (ethics committees, patients, health authorities)
- Identifying potential risks of over or under enrollment within a given region or for the trial as a whole
- Identifying potential misconduct or fraud related to enrollment reporting
Obviously there are barriers to making this proposal a reality – sponsors would likely be the ones providing the update to the numbers, and since high-recruiting investigators are like gold, they would likely be reticent to share that information. But I further believe that access to this type of information, in addition to the benefits for the ‘greater good’ noted above, would foster more recognition & pride in site performance, addressing another big problem by drawing more investigators into the fold of clinical research.
We’ve seen proof of the power of transparency at goBalto. Our Tracker solution for study startup enables sponsor, CRO, and site teams to have total visibility to progress, performance, and responsibilities of each party during the site initiation process. In reports from our customers and ‘exit interviews’ with users, we’ve seen that transparency result in faster completion of site startup activities. Like the authors of this paper, we believe and support the notion that the level of transparency in clinical trials “should be taken beyond the current limits.”
About the Author
Todd Tullis is the Director of Product Management at goBalto. Prior to goBalto, he spent 12 years contributing to and leading initiatives at some of the world’s largest clinical development organizations such as Merck, Pfizer, Boston Scientific, and PPD.
