HIV: MEDICAL TREATMENTS-EXPERIMENTAL DRUGS AND CLINICAL TRIALS: SUPERVISION OF CLINICAL TRIALS
To be sure that the potential benefits of a trial are larger than its potential risk, the FDA requires that all trials be supervised by an independent review panel. This review panel, called the Institutional Review Board (IRB), must be composed of representatives from both the medical field and the nonmedical public. Most IRBs include representatives from law, nursing, medicine, and the clergy, as well as researchers who are expert in clinical trials. This group has the job of watching out for the participants’ interests, seeing that scientific standards are upheld, and protecting medical ethics. At periodic intervals during the course of the trial, the IRB reviews the results. Any serious or unexpected toxicity must be reported immediately to both the IRB and the FDA. If the toxicity is serious and is thought to be related to the drug, all participants in the trial must be notified, and the informed consent form must be revised accordingly. Many trials, and especially those at multiple medical centers dealing with treatments of serious conditions such as HIV infection, are also supervised by a Data Safety Monitoring Board that scrutinizes the data from the trials every six to twelve months. The Data Safety Monitoring Board, made up of experts in the field who are not involved in the trial, is also privy to unblinded results. This board is different from the IRB because it has access to data from all centers participating in the trial, not just the local center. The board’s purpose is to stop the trial as soon as valid results combined from all centers emerge about the drug’s effectiveness or toxicity. Six months into the phase two trials of AZT, the Data Safety Monitoring Board’s review of the unblinded data convinced it to stop the trial and give all participants AZT. One year into the second big AZT trial, the data showed that the drug was beneficial when the CD4 count was below 500, arid that it was less toxic at low doses; the trial was stopped and all participants with low CD4 counts were given low doses of AZT.*188\191\2*
