What is a Clinical Research Study?

A clinical research study is a carefully constructed scientific research study that intends to advance treatment of various medical problems by gathering a group of patients with a specific medical problem (for example, asthma) and studying the beneficial effects and/or problems with a new proposed treatment for that medical problem.

All new medications used in clinical trials are first tested in animal models, and then in preliminary small human trials, called Phase I and Phase II trials. If the benefits appear to be significant and no significant toxicity is noted, the preliminary studies are reviewed by the FDA. If the FDA finds no problems, the study of the new medication will be approved for a Phase III clinical trial. A Phase III trial typically involves some form of a double blind study in which neither the patient nor the physician knows whether an active medication or placebo (inactive control) is being administered. The purpose of the study is to objectively determine the significant benefit of the new medications by comparing the results from those patients receiving the active medication to those receiving the placebo. Since these studies are carried out among dozens of separate clinical investigators at different sites, a statistical analysis of the results is usually quite accurate in determining the real benefit of a medication.

Clinical trials are carefully regulated by the FDA and coordinated by the pharmaceutical and research companies involved. The physician investigator’s work is carefully and regularly reviewed by the sponsoring company’s research coordinator. Each patient participating in the study receives a full review of the study design, the study medication, and information on the potential benefits and side effects. Each patient will also be required to sign an Informed Consent in which all the relevant issues are outlined.