Demystifying Clinical Trials
by John Patrick Pullen
Human guinea pigs, unknown side effects, experimental treatments, and endless testing: these are some of the misguided impressions that people have about clinical trial—none of which, incidentally, are grounded in fact. There is a truth that people sometimes fail to consider when it comes to medical research studies: every medicine or medical device—from acetaminophen to pacemakers—has been fully vetted through closely monitored, highly regulated clinical trials in order to insure their safety and effectiveness.
“Every drug that people have ever taken, vaccines that their children have taken, flu shots that they get, are all available because of the gift that other individuals have given by participating in clinical research,” says Christine Pierre, president of RxTrials, an Ellicott City, Md. based network of investigative sites.
Clinical trials vary widely due to the nature of the medications they test, but at their essence, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Clinical trials are governed by strict protocols, and are overseen by many regulatory bodies, from the Food and Drug Administration (FDA) to small Independent Review Boards (IRBs).
“It’s a very thoughtful process that people go through to develop drugs,” says Steven Steinbrueck, president of Stonebridge GCP Consulting, a Newtown, Penn.-based consultant. “Before the first people ever get them, (drug developers) really have a feeling that this drug is safe and it’s going to do what it’s supposed to do.”
In fact, says Steinbrueck, if a drug developer starts with an average of 5,000 possible formulas, they will throw away 4,990 compounds that they don’t have confidence in. “Out of the remaining ten, only one makes it to market,” he adds.
Clinical trials are typically conducted in four phases. Phase one is when generally healthy people are given the medication to test the ingestion of the pill or treatment will have no adverse, toxicological effect. Phases two and three dive deeper into the safety, effectiveness, and dosage of the medication, and it’s after these stages when the FDA would approve the drug or device. Phase four examines new uses for previously approved treatments. For example, minoxidil was developed to treat high blood pressure but was found to reverse the effects of male-pattern baldness; it’s now marketed under the name Rogaine.
It’s important for participants to understand the many mechanisms that ensure the safety of the test subjects. Tests and studies are subject to strict regulations and guidelines through the FDA, Department of Health and Human Services and the Department of Health and Human Services. And each trial is monitored by Independent Review Boards (IRBs), a group of independent medical experts, ethicists, as well as lay people, to share the volunteers’ perspective. Researchers report periodically to the IRB, outlining such things as contact with patients, the tests conducted, the results recorded and even the side effects reported. To ensure the safety of human subjects’ it’s important for IRBs to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
These safe guards are in place to make participation a safe experience, since as Pierre notes, “People who participate are giving the gift—they really are the heroes that are helping to develop the new drugs, devices, biologics, and treatments for the future.”