Drugs become accepted by physicians and the FDA on the basis of scientific proof of their effectiveness and safety. Scientific proof is obtained through a series of tests called a clinical trial. A clinical trial involves the combined efforts of the pharmaceutical company that makes the drug; the independent investigators who test the drug; and the FDA, which licenses the drug. Testing drugs through clinical trials has been standard for over four decades and has provided the foundation for most of the recommended treatments in traditional medicine. While a drug is being tested in a clinical trial, it is considered experimental. If the drug proves effective and is not too toxic, it is then licensed and available to the public. For people with HIV infection, participating in clinical trials has both advantages and disadvantages. Clinical trials are experiments with human lives, and special safeguards are necessary to guard both the people and the scientific procedure. These safeguards, plus the options and aspects of participation in a clinical trial, are spelled out to the participant in painstaking detail. Some trials can be seen as especially risky: they involve taking a drug with no established benefit in place of a standard drug with established merit. With other trials—for instance, the comparison of two drugs, both of which are known to work, to find out which works better—the risk is lower. The motivation to participate is an individual decision. For further discussion, see below, “Advantages of Participating in a Clinical Trial” and “Disadvantages of Participating in a Clinical Trial.” Anyone worried about the safety of a clinical trial can be reassured that the trials are conducted under the strict supervision of the FDA and a local board charged with reviewing the trial. Both the FDA and the local board periodically review the results of the trial. If the drug being tested proves significantly better or worse than the drugs in standard use, the trial is promptly discontinued. Moreover, a standing rule in all clinical trials is that participants may withdraw from the trial at any time.*183\191\2*
-
Posted by admin @ 2:55 pm
