The Role of FDA’s Center for Drug Evaluation and Research (CDER) in Disqualifying Researchers from Clinical Trials for New Medications
The U.S. Food and Drug Administration’s (FDA) Bioresearch Monitoring Program plays a critical role in helping the Agency ensure that clinical researchers who conduct studies of new drugs, biologics, and devices in humans protect the rights, safety and welfare of people who volunteer to be in a study and collect accurate study results.
The FDA's Center for Drug Evaluation and Research’s (CDER) oversight role in this process is focused on clinical research on drugs and certain other types of medications known as therapeutic biologics. The FDA has the authority to “disqualify,” or prohibit researchers from conducting such clinical testing when the agency determines that a researcher has repeatedly or deliberately not followed the rules intended to protect the people in the study and/or ensure data integrity. CDER has strengthened safeguards for clinical research by taking swifter actions to disqualify clinical researchers who do not follow the rules.
Q: What has CDER done to improve its handling of disqualification actions?
A: In July 2009, CDER’s Office of Compliance, Division of Scientific Investigations (DSI), realigned its organizational structure to create a branch that focuses predominantly on serious allegations of non-compliance and cases that appear to warrant disqualification. Having staff responsibilities for this area concentrated in one branch is improving the Center’s handling of the disqualification process. The realignment has reduced competing priorities and improved consistency in these matters. For example, in the past, the same DSI staff members responsible for processing disqualification matters were also responsible for overseeing clinical investigator inspections associated with New Drug Applications (NDAs), so that actions such as disqualification had to compete with review of inspections associated with NDA-related deadlines.
Q: How have these changes affected the time it takes CDER to complete disqualification actions?
A: The changes within CDER, specifically within DSI, have significantly increased its efficiency in disqualifying researchers. According to an evaluation by the Government Accountability Office (see http://www.gao.gov/products/GAO-09-807) the time needed to disqualify a clinical investigator (in all FDA Centers) averaged 2.8 years between 1998 and 2001. Between 2002 and 2005, this time was shortened to 0.9 years. Between 2006 and 2008, the time improved even further, to 0.5 years. In fiscal year 2008, for CDER disqualifications only, DSI initiated disqualification of five clinical investigators, and the average time for resolution of these cases was only 4.6 months. In fiscal year 2009, DSI initiated five disqualifications; three have been completed and two were still pending as of October 2009.
Q: What else has CDER done to help ensure the integrity of clinical research?
A: Other program offices within FDA also oversee the integrity of clinical research. CDER works closely with these groups to ensure a coordinated effort. For instance, the FDA’s Office of Regulatory Affairs (ORA) has assumed CDER’s previous responsibilities for enforcing a legal action known as debarment, used to bar researchers who have been convicted of certain felonies and misdemeanors involving drug products. To further help ensure public safety, DSI has improved communication between DSI and ORA, so that DSI is made aware of debarment cases that may be appropriate for disqualification, and ORA is made aware of disqualification cases that may be appropriate for debarment. In addition, CDER works closely with FDA’s Office of Good Clinical Practice, which provides central coordination of the disqualification process for all FDA Centers, to help ensure that disqualification procedures are followed and timelines are met.
FDA has been enhancing its oversight of clinical trials for several years.
In August of 2009, the Agency issued a press release on these efforts. Read the release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176040.htm.
FDA has also posted Questions and Answers on the Agency’s overall procedures for overseeing the integrity of clinical trials research http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176043.htm.