Last week I wrote an article on what the newly revised GCP guidelines will mean for clinical researchers. This blog post will focus more specifically on how clinical trial sponsors will need to have more oversight on their own studies even when they are being outsourced to contract research organizations (CRO's).
Sponsors, much like Principal Investigators at their own clinics, have always been held fully responsible by the FDA and other regulators for the oversight of their clinical trials. With the emergence of new technologies such as virtual workspaces, data analytics, and the like, Sponsors are now able to take an individualized risk-based approach to the implementation of the trials that they are funding. In this article I discussed risk based monitoring and how this innovation is already making tremendous progress in the clinical research industry.
Gone are the days of a clinical trial sponsor outsourcing the entire clinical trial process to a CRO and providing little to no oversight. New GCP guidelines call for a more proactive approach complete with individual site monitoring plans, safety measures, and risk aversion whenever appropriate. This means more documentation from the CRO and CRA stakeholders, as well as the Investigative sites. This also means that a risk based approach will need to have formal plans in place that the FDA will hold the Sponsor accountable towards.
It will be interesting to observe how things progress, and also how enforceable these new mandates are going forward, specifically with Trump's Pharma-friendly FDA appointee. As we have seen before with clinical trial results often going unpublished, new mandates don't always bring immediate change.