It’s not going to be business as usual at the U.S. Food and Drug Administration (FDA) going forward, new Commissioner Scott Gottlieb told attendees of the RAPS (Regulatory Affairs Professionals Society) 2017 Regulatory Convergence conference on September 11.
There are many areas where the agency wants to increase its activity, Gottlieb said. For example, the agency needs to more proactively work with all stakeholders in clinical trials to get them to cooperate with one another and better share information. The FDA is pushing many new initiatives Gottlieb believes will speed trials and improve efficiency and efficacy.
Some of these efforts already are under way or completed. Recently, the agency issued a guidance that assures sponsors, investigators, and institutional review boards (IRBs) the agency “does not intend” to object to an IRB waiving informed consent requirements for certain minimal risk clinical investigations (for more information, see FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies). Members of clinical research teams can look for a number of agency guidances and open meetings on other topics over the next 12 months, Gottlieb advised.
FDA is also committed to modernizing how it collects trial information, supporting intelligent use of adaptive approaches that can help to identify patients less likely to suffer adverse events during or after a trial, and that promote “seamless” trials. In the latter, Phase I, II, and III trials are hewn into a single trial with connective breaks in-between the project’s transitional movement through the trial process.
Gottlieb also said the agency would work to encourage use of “master protocols” to help industry use a proven clinical trial structure across a number of disease subtypes.
Author: Michael Causey