The FDA will soon issue a final guidance distinguishing between adverse events and unanticipated problems in clinical trials, clarifying when the former have to be reported to an institutional review board (IRB). The agency also is working with the Health and Human Services' (HHS) Office for Human Research Protections on a final rule for registering IRBs.
Existing FDA regulations do not take into account the different types of organizations—vendors, co-investigators, site management organizations and contract research organizations—involved in conducting clinical trials, said David Lepay, the FDA’s senior advisor for clinical science, at the Association of Clinical Research Professionals (ACRP) conference in Washington, D.C.
FDA regulations fail to account for electronic data issues, data standardization, EHRs, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” according to Lepay.
After releasing the final guidance, the agency will “probably institute regulatory changes to make it clearer,” said Jean Toth-Allen, of the FDA’s Good Clinical Practices Program, at the ACRP conference.
Currently, it is the responsibility of the trial’s sponsor to report serious and unexpected adverse events to the FDA. While clinical investigators are not required to report adverse events that do not fall into this category to the IRB, they must record all adverse events on case report forms and submit them to the FDA in annual reports, according to Toth-Allen.
The regulations on devices stipulate that clinical investigators must report unanticipated adverse device effects within 10 working days to the sponsor and the IRB, according to the agency.
The FDA also said it is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay said. Recently, Reps. Joe Barton, R-Texas, and John Shimkus, R-Ill., asked the Government Accountability Office to examine why the agency has hesitated to discipline its investigators.