Medical research has a long history of twists and turns – research with serendipitous discoveries or dedicated efforts to move a hypothesis into theory and realization. Such research and awesome discoveries and their applications have improved our health substantially. We are always on the cusp of new technologies and treatments, or even cures of diseases and conditions once thought inevitable and incurable. It is important to understand how clinical trials further research goals.
The Columbia University Irving Medical Center Department of Otolaryngology Head and Neck Surgery explains on their website (2018): “A clinical trial is a research study using human volunteers, which is intended to add to medical knowledge. Participants receive a specific intervention, such as a medical strategy, treatment or device, to determine whether it is safe and effective for humans.”
Such trials are often the culmination of long research processes which may begin in laboratories or animal testing. Strict scientific standards are applied to both protect participants and confirm reliable results.
According to the University of Michigan, Michigan Health’s Blog (April 17, 2018), there are several stages to a clinical trial for new drugs and treatments. https://healthblog.uofmhealth.org/health-management/different-phases-of-clinical-trials-and-what-they-mean Quotes below are attributed to Vallerie McLaughlin, M.D.
Phase I: testing of a new medication or treatment for the first time. “Usually a trial in healthy volunteers to get the information about the dosing of a drug and about the side effects which might be expected.”
Phase II: Testing of a larger group of participants with the same condition or disease “to get information about how effective the drug is to treat certain parameters of that disease.”
Phase III: Phase III is also called a pivotal trial; it marks the formation of those participants on the new drug and those participants receiving a standard treatment or placebo (definition: a substance that has no therapeutic effect and is used as a control in drug testing).
Phase IV: this phase takes place after federal approval and is meant to find “other indications or scenarios for the drug.”
We will learn more about clinical research in part two of this discussion.