Clinical trials are research studies that utilize human volunteers, as individuals or in groups, to help researchers evaluate health-related interventions to evaluate the effects on health-related outcomes. Subjects are chosen from diverse groups of people reflecting both genders at variety of ages and ethnicities unless the study pertains to one specific type or group. The studies are divided into Phases according to which stage of development the health-related interventions being tested are established.
Phase 0 studies usually only involve a small number of people and they only have a small dose of a drug. Researchers are trying to find out if the drug reaches the root cause of the condition and how the drug interacts with the body.
Phase I studies a
re generally small, with just a few patients. Once testing indicates a n
ew treatment might help treat its target condition, phase 1 trials are done to determine what dosage of the drug is safe to use, what, if any side effects are generated, how the body copes with the drug and If the treatment is effective in treating the condition.
Phase II trials are designed to determine if the new treatment works well enough to test in a larger phase III trial, whether or not there are inherent side effects and a method to deal with them and to ascertain the most suitable dose to use for the best, safest results.
Phase III trials may compare new treatments with the currently recommended treatment to see how a completely new treatment compares with the standard treatment, to determine different doses or ways of giving current treatments. These trials will generally involve a larger number of subjects than phase I or II as differences in success rates may be small and more patients are required to show the difference.
Phase IV trials are done after a drug proven effective and is granted approval. Phase IV trials are conducted to learn more about any side effects and safety of the drug for general use. This phase is also used to determine how well the drug works in larger populations and to explore the drugs longer term risks and benefits.
WHY DO SUBJECTS GET INVOLVED IN CLINICAL STUDIES?
People volunteer to participate as subjects in clinical studies for myriad reasons. Some subjects that suffer the conditions for which a new treatment is being studied become involved to have access to the latest treatments available and, hopefully; to help hasten the development of a new tre
atment that will benefit them. Others want to play a more active role in their own healthcare and to understand their ailment and methods of treatment more completely.
Most study subjects, especially healthy participants volunteer for more altruistic reasons such as helping to advance medical science to the benefit of everyone, to ease suffering and to offer hope to those suffering chronic conditions. Some subjects state that they want to “pay forward” the benefits they have experienced due to the efforts of past volunteers who have helped in the development of medications and treatments that have had a positive influence on their lives.
Whatever the reason; volunteering as a clinical study subject can have a long lasting impact on the advancement of medicine and the well-being of future generations. The next time you take a medication to ease, treat or even heal an ailment…remember… the relief you experience is partially due to the efforts and generosity of clinical study volunteers.
Authored by: Jack Beaton, RA, CMA
Medically Reviewed by: Marc Shay, MD