By Patricia Prewitt, Consumer Education Advocate
No question, Massachusetts, especially Boston, is internationally recognized for its top-tier medical schools, hospitals and health care specialists. Biotech and research labs thrive in our area—companies often conduct clinical trials here to test new products or medical devices.
What are clinical trials? Research studies in people are needed to test new medications or devices. Most common are “Phase Three” studies, conducted after the medication (or device) has cleared the Phase One and Phase Two hurdles for safety and effectiveness. During Phase Three, the product will be tested against a placebo (it looks the same, but has no active ingredient) in thousands of volunteers who suffer with the condition. It might also be tested against another medication to see which is better.
Phase Four clinical trials or “Post-Marketing” clinical trials are conducted after the product has been on the market.
Why would I consider being a human guinea pig? Testing medications, devices or interventions in people who suffer with a disease is a vital part of supporting scientific discovery. Before any clinical trials are conducted in a medical research institution, the trial protocol undergoes a rigorous IRB (Institutional Review Board) process to make sure it is safe for the participants.
What’s in it for me? If you suffer with a particular medical condition, you benefit from additional physician visits, bloodwork and other monitoring that is at no cost to you, or your insurance plan. Often, participation may make you eligible for “early access” to a newer medication or intervention. Generally, a small stipend ($25-$50) is paid for each visit, and parking fees are usually covered.
Sounds interesting—How would I find out about a clinical trial in my area? Ask your provider at the next office visit. Over 329,000 publicly and privately funded clinical studies have been registered with The National Library of Medicine (NLM) at the National Institutes of Health (NIH) website.
What else should I know? Clinical trials are quite varied and unique. It may be only one visit; some may require visits every week, and others may last for a year or more. Phase Three participants are “blinded”—you do not know which group you are in. If you are assigned to the placebo group, you would not be receiving active medication. Think of it as contributing to the greater good.
Notes from the author: Over the course of my career, I have participated in a number of clinical trials—and so have my children. Only a few years ago, while attending a lecture on sleep and circadian rhythms in teenagers, I realized the data being presented had to include my own (now grown) child in the numbers. I was delighted to learn that my child contributed to an important scientific publication related to teenage brains and sleep.
In 2006, my 13-year-old child had found a sleep study that paid teenagers in savings bonds. The bonds matured in time to help with costs for the last year of college. I am currently participating in a 5-year clinical trial at Brown University in RI.
About the Author: Patricia Prewitt is a local Massachusetts resident who spent over 30 years in the pharmaceutical industry. Tricia is a consumer education advocate, and loves helping people find ways to save money on their prescriptions. More information and free resources are available on her website at https://mypersonalrxadvisor.com or call her at 508-507-8840. Favorite Quote: “Act as if what you do makes a difference. It does.”—William James
