Clinical Trials

Clinical trials are research studies that enroll patients to evaluate new treatments which seek to improve upon existing treatments. Before their use on patients, new therapies are studied extensively in the laboratory. This preliminary investigation helps select the most promising treatments and determines the safest and most effective means for administration. Only through these trials can new information be obtained which can change the standard of cancer care. Clinical trials are the crucial link between the laboratory and the pharmacy shelves for new drugs, yet most lay people have little understanding of the process; the average person's exposure to clinical trials may run no deeper than advertisements soliciting recruits for new studies, which often offer compensation for participants. The first phase in a clinical trial begins only after extensive tests have been conducted in the laboratory using tissue cultures, animals or both. The U.S. Food and Drug Administration (FDA) have enforced a set of guidelines for research on humans. This set of guidelines is set to begin with a small study of healthy volunteers. Subjects or volunteers receive closes of the drug being studied, to gauge side effects, determine safe dosages and observe how the drug is metabolized. In the second phase of a clinical study, the medication or treatment is administered to a somewhat larger group of people who have the specific condition it is intended to treat.

If the earlier trials show promise, a third phase involving a large sample group helps researchers determine with greater precision the drug's efficacy. In investigational trials, scientists may administer placebos to a control group; often the researchers themselves are not aware of which patients are receiving the medication or the placebo. FDA guidelines are designed to prevent abuses of the clinical trial system. Researchers must obtain informed consent before subjects can be included in clinical trials, meaning that participants must receive adequate information about the risks and responsibilities involved, and about treatment options available.

Any clinical trial seeking an FDA research permit must also be monitored by an Institutional Review Board, consisting of at least five people with varying backgrounds which must include a member from a nonscientific discipline and one not affiliated with the research institution in question.

Such trials, which can be very costly, are often funded by the drug companies which want to push the product on to the market. The payoff can be big but very infrequent. The Pharmaceutical Research and Manufacturers Association in Washington, D.C., estimates that only five in several thousands of compounds that enter preclinical testing ever make it to trials involving humans. Of those five, only one will ever reach the pharmacy shelf after the necessary approvals.  The federal government provides major funding for clinical trials through organizations such as the National Cancer Institute. But most of such clinical trials are neutral, i.e. they do not favor any particular pharmaceutical company over another. Thus, clinical trials are part of the progress we need to make in the world of science and to provide better medical drugs available to the evolving diseases out in the world!!