Health Advisory: Focus- Human Clinical Trials- Clinical Trial Issues Suddenly Loom
6/1/2000
This advisory discusses the increased federal oversight of clinical trials. Clinical trials, the process by which the safety and efficacy of new drugs and medical technology is tested, have long been under the review of the Food and Drug Administration and local institutional review boards. In June 2000, the oversight for these trials increased to include senior officials of the Department of Health and Human Services (HHS) through the Office of Human Research Protection as well as Congress. In order to encourage a more representative patient population in clinical trials, the White House ordered HHS to allow Medicare to cover the costs of patients in certain trials.
