U.S. Food and Drug Administration
Performance Plan
2002
To better protect the rights and welfare of volunteers who participate in clinical research studies
|
Protect human research subjects' participation in drug studies and assess the quality of data from these studies by increasing the number of onsite inspections. Increase the number of inspections of medical device studies with an emphasis on vulnerable populations such as the mentally impaired and children. |
FDA is the only government agency with a regular program of on-site inspections to evaluate the performance of Institutional Review Boards (IRBs), clinical investigators (CIs), sponsors, and others involved in the conduct of research involving human subjects.
Heightened concern for the rights and welfare of volunteers in clinical studies followed the recent death of a research subject in a gene therapy trial, and studies by the HHS Inspector General and others criticizing existing Bioresearch Monitoring (BIMO) oversight programs.
Two other developments underscore the need for a well-funded, effective oversight body. First, the rapidly changing research environment has led to a proliferation of multi-site clinical trials, an increase in clinical trials using vulnerable populations, and the growth of new types of research, particularly related to genetic therapies and new technologies. Second, FDA's inspection program continues to uncover problems in clinical research practices related to: failure to follow the study protocol, failure to maintain accurate case histories on study subjects, problems with informed consent documents, failure to report adverse events to FDA, and failure to obtain IRB approval for protocol changes.
FDA believes that it can enhance safety of volunteers in clinical studies by significantly increasing the number of inspections, focusing on high-risk situations and responding rapidly to potential problems.
FDA will:
Failure to achieve the goals may result in needless deaths and suffering of participants in clinical trials.
The following chart shows that FDA inspected a small sample of all the clinical trials in FY 2000. While the Agency understands it cannot inspect every clinical investigator, added funds will allow the FDA to focus its inspectional efforts to lower the risks to volunteers in clinical trials.
