The future of revolutions in communication between study sites and sponsors is being crafted even now through the Shared Investigator Platform initiative described by project members yesterday in a session at the ACRP 2017 Meeting & Expo in Seattle.
As described by Summer Iverson, associate director of global clinical trial execution for Pfizer, and Kelly Kirsch, MPH, a consultant on clinical development information and optimization for Eli Lilly, the platform is a single sign-on resource for eliminating redundancy of effort in terms of principal investigators and sponsors being able to share information with one another about trials. Both of the speakers’ firms are partners in the TransCelerate BioPharma Inc. nonprofit collaboration of 18 major pharmaceutical companies, which aims to improve the conduct of clinical trials through a variety of initiatives, including the Shared Investigator Platform.
In part, the session speakers said, the platform addresses an unmet need of investigators to have simplified access to sponsor-held data on larger trials in which they are just one of many researchers participating. It also reduces investigators’ burdens in terms of entering information that many sponsors can see about their sites when vying to potentially take part in studies. On the other side, sponsors benefit from having a single source of information on investigators’ qualifications, facility capabilities, staff training levels, and more.
From the sponsor perspective, the platform is under ongoing development “with sites for sites,” Iverson and Kirsch noted, to address challenges in key areas such as document flow, data reporting, study feasibility surveys, and (yet to come) safety notifications.
Although operating on an invitation-only basis from sponsors at the moment, the speakers said that future outreach efforts will be made to open up the platform to more investigators who aren’t already involved—or being solicited for involvement—in sponsors’ specific studies. Ultimately, the goal is that the platform will not even be exclusively for the use of TransCelerate partners, but open to all sponsors and sites wishing to be involved.
Author: Gary Cramer