Understanding the Clinical Drug Development Process

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The ins and outs of clinical drug development can be confusing and complicated. It is a system designed to be thorough and meticulous to ensure that adequate levels of safety and research ethics are complied with throughout the process. Most Americans (over 95% according to one study) never participate in clinical drug development studies, yet the value of such medical research studies is significant. Just over 45% of those surveyed indicated that they somewhat agreed with the statement: Participating in clinical trials is as important to the health care system as donating blood. So how do clinical trials work?

Most clinical trials are sponsored by pharmaceutical companies or other interested parties who want to test whether a new drug can offer some form of treatment for an existing condition. There are different types of clinical trials. Some may test healthy volunteers, while others might recruit patients with an existing illness or condition. For those suffering from a chronic or terminal illness, experimental drug trials can offer some form of hope especially if other treatments have not yielded positive results or there is no existing treatment. Medical research studies usually recruit participants on the basis of specific criteria.

Part of the clinical trial process is to compare results with alternative treatments already on offer to test the efficacy of the drug in addition to its safety. The testing process is divided into phases. A phase 1 clinical trial, for example, tests the safety of the drug on a relatively small group of participants (20 to 80). The number of participants increases through the various phases and the scope of the study is expanded or refined through each phase to ensure that ultimately the various side effects are identified and monitored, the effectiveness of the drug is gauged, and the safest and most effective administration of the drug is identified. The impact of different dosages might be examined. for example, does increasing a dose from 5 milligram to 10 milligrams increase efficacy or result in noticeable side effects.

Some demographic groups such as pregnant women or those over the age of 55 may be excluded from clinical trials due to concerns over safety. If children are used in clinical drug development studies then the consent of their parents or guardians must be obtained. All participants in a clinical study must give informed consent as spelled out in most ethical guidelines including section 8.02 of the 9th revision of the American Psychological Association’s Ethical Code.