In a previous Scope entry, Inspire contributor and cancer patient Linnea Duff explained why she no longer views clinical trials as a last resort, but rather as her “next good chance.” Similarly, in a video series produced by the Stanford Cancer Institute a group of patients discuss how clinical trials offered not just the opportunity for a potentially more effective avenue of treatment but also the chance to contribute to medical research.
A piece today in the Huffington Post offers a simple breakdown of the key facts for other patients considering participating in a clinical trial, and two Stanford experts provide comment on the potential risks:
…Observational studies — such as the sharing of medical files — typically pose no added risk, and the risk of interventional studies depends on numerous factors. For example, if two known drugs are being compared to see which is more effective in the treatment of a particular illness, the risk is low. It is important to note that even if a medication is FDA approved, an individual may suffer adverse side effects. If an unknown drug is being tested, however, the risk depends on how far along that drug is in the R&D phase: The more it has been tested, the less risky it is. Even tried-and-true drugs or procedures may be risky, adds Rebecca McCue, division research manager of the Stanford Systems Neuroscience & Pain Laboratory (SNAPL), such as in the case where an FDA-approved drug is used to treat an illness other than that for which it was approved.
While holistic intervention such as cognitive behavioral therapy poses negligible risk, other alternative medicine therapies may pose some risk. “A number of alternative therapies don’t go through approval with the FDA,” explains Sean Mackey, MD, PhD, Chief of the Division of Pain Management at Stanford University. For example, he says, nutritional supplements are unregulated by the FDA and therefore “have not been through the close scrutiny that pharmaceuticals go through. The vast majority are not dangerous agents, but we simply don’t know their long-term safety and efficacy… We haven’t studied a lot of these over-the-counter supplements in large-scale trials, because there are not drug companies interested in doing that.”
Previously: Patients share clinical trial experiences at Stanford and Clinical trials: My next good chance
Photo by Stanford EdTech