Clinical Trials within U.S.: Blind Process

CLINICAL TRIALS ARE scientific experiments designed to determine whether new procedures, drugs, or agents are beneficial to those human patients involved. Customarily, a blind process is used in which the new drug (or other treatment) is tested against a placebo, which is a harmless substitute of the same basic size and shape that will not provide any medical benefit. Patients selected to participate in the trial will be divided randomly into groups taking either the new treatment or the placebo. Only when the group not taking that placebo shows statistically significantly higher levels of outcome (however this is measured in medical terms) than the placebo—taking group can the trial be determined a success. This blind process is necessary because there is a clear incentive and a propensity for patients to report an improvement in their condition, or for carers to do so if the patient is unable to provide such a report.

Clinical trials customarily take place a considerable period of time after the initial creation and development of a new treatment, which will then proceed, depending on local legal conditions, to animal testing. This procedure is lengthy and is customarily processed with due regard to safety and scientific rigor. One important implication of this procedure is that pharmaceutical companies seeking to bring new drugs to market have generally had to sponsor many years, and even decades, of expensive research scientists and medical laboratories before new drugs can pass relevant legislative controls and be brought to the market. This makes new drugs expensive, as the costs are used not just for profits but also to cover the extensive period of testing and research that preceded entry to the market. In some countries, where undemocratic regimes are able to suppress public opinion, free speech, and the accountability of pharmaceutical companies to be responsible for the ill effects of their products, the cost of drugs and the speed with which they can be brought to market can be considerably reduced, albeit at a human cost that can be very high. In the United States, the prominence of the legal profession ensures that this form of behavior is prosecuted, if not prohibited.

The extent of national and international cooperation in medical research provides numerous opportunities for more rapid and broader—based solutions to be identified. Myeloma, for example, which is a blood cancer that occurs within the bone marrow, has been found to have promising new treatments resulting from clinical trials. Stem cell research has also provided material for clinical trials. A stream of research from the University of Texas Medical School at Houston, for example, has examined the possibility that children with brain injuries may find some relief from secondary effects by using stem cells from their own bone marrow tissue. This research has also provided some positive results.

The National Library of Medicine lists a large number of university schools and other institutions pursuing stem cell—involved clinical trials. Prospective patients may search for opportunities to participate in such trials online, and other online resources also provide advice and support for patients and their families and carers. Private—sector [Page 118]brokers also exist, aiming to connect would—be patients with suitable trial providers. As ever, care should be taken when determining whether such a service would be helpful in individual cases.

...