FDAnews Device Daily Bulletin

FDA Official Sees Push for Clinical Trial Rules

May 9, 2008

The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.

Existing FDA regulations do not take into account all the different types of organizations — vendors, co-investigators, site management organizations and contract research organizations — involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, said last week at the Association of Clinical Research Professionals annual conference.

FDA regulations fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said.

The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay said. Recently, U.S. Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.) asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators.