Medical Journeys

Clinical Drug Trials

United States federal law requires that all new drugs pass clinical trials before they may be legally prescribed. This is an expensive and usually time-consuming process that is designed to compare the new medication  with existing treatments for the relevant conditions. The trials are also an opportunity to discover possible side effects. Because they are so expensive, clinical trials are usually subsidized by the government, biotechnology firms and/or pharmaceutical manufacturers. However, the actual testing is usually carried out by an outsourced research firm that specializes in drug tests. These organizations are highly experienced in clinical trials and are able to efficiently coordinate the vast groups of people and services necessary to conduct them

Types of Trials

There are several different types of clinical trials; the methods employed depend on the stage of drug development and the drug’s intended applications. The subjects normally fall into two categories: healthy individuals, and those suffering with the malady the new drug is intended to treat.

New drugs (known as clinical trial materials) must first undergo a double-blind clinical trial, which tests for the placebo effect. Placebos are inert decoy substances that are administered to some test subjects; the subjects believe that they have been given the actual drug, and consequently may report some improvements in their condition that are quite literally “only in their head”. All subjects in the double-blind trial are examined for improvements, and the effects of the placebo are compared to that of the drug. If the drug demonstrates more power than the placebo, it is ready for the next phase: an active comparator study. Active comparator studies are frequently used to compare new drugs with treatments that are considered the standard of care.

Consent and Statistical Power

All types of clinical trials require the subjects to give informed consent; the subjects must agree to participate in the test and be given accurate information about the drug being tested. Many trials require juvenile subjects; because they are minors, juvenile subjects may only take part in the test if their parents give written consent. The efficacy and statistical power of clinical trials is determined predominantly by the size of the subject pool. The larger the pool, the more powerful and valuable the trial becomes. Power refers to the trial’s estimated ability to accurately predict how the drug will affect patients in the medical marketplace.

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