Each month, we will feature several questions that volunteers like you submitted about participating in clinical research. Christine Hunter, R.N., C.C.R.C., a trial coordinator at Baylor College of Medicine, has generously offered her perspective on these questions. Submit your question to email@example.com and check back in upcoming months for the answer!
This month’s questions involve participation in interventional trials, which test a new drug or procedure.
1. How risky is it to participate in an interventional trial?
Christine Hunter: There are risks to all medications on the market and in general, clinical trials are not particularly risky. However, there are specifics to each trial, so it is important to speak with the study doctor and/or coordinator to ensure you are fully informed. There can be great benefit in the amount of oversight that a clinical trial provides to participants. Many trials include procedures such as electrocardiograms, blood tests, x-rays, MRIs, etc., that you may not receive in your routine care—or at least as often as in a study. At our center, there have been instances where a new disease or condition was detected by a standard procedure performed during a clinical trial. This has the potential to avoid serious outcomes that might have occurred had the patient not undertaken those procedures and detected the new condition so early on. Also, the scrutiny involved in clinical trials can help improve patients’ overall health. This should always be a goal in any research study.
There is always the opportunity for a participant to withdraw from a trial at any time — should they not feel amenable to any risks in the trial.
2. Is it safe to continue taking my current medications while in the trial? Are there known interactions or side effects between any of my current medications and the interventional treatment?
CH: Depending on the type of trial you are participating in, this will vary greatly. Most trials have allowed and disallowed medication lists that detail the known interactions between the given intervention and the medications listed. It is important for participants to review this list carefully.
Informed consent forms also discuss medical interactions. Yet it is impossible to know every interaction that could occur. Many times new interactions occur once the intervention is on the market. These can’t always be identified during the research process, as study participants won’t cover all aspects of the general population.
3. What research has been done thus far on interventions being tested in trials? How can I learn more about those results?
CH: Clinicaltrials.gov posts publications that offer results of clinical research. Publishing results can be a slow process as it is necessary to ensure that the results are in a usable format that is also accurate. Participants can review research results on clinicaltrials.gov by reading the research studies there. They can also check the Parkinson Study Group (PSG) website if the trial was conducted as part of this group.
4. Is it possible to continuing receiving the interventional treatment after a trial has ended? Or if I receive a placebo, can I get the interventional treatment after the trial has ended?
CH: Depending on the phase and results of the trial, it can be possible for participants to enroll in an open label extension study where those who received the placebo can receive the intervention. Those participants who received the intervention during the trial can continue receiving it after the study ends through open extension studies as well.
Phase 2 studies often can’t offer an open extension as they are still testing efficacy of the intervention. Phase 3 studies may be more likely to offer an open extension until the intervention is approved and on the market.
Many research sites look to conduct studies that offer open extensions as a benefit to their participants. Discuss your study specifically with the trial coordinator, and whether an open extension study may be available.
NOTE: The medical information contained in this article is for general information purposes only. The Michael J. Fox Foundation has a policy of refraining from advocating, endorsing or promoting any drug therapy, course of treatment, or specific company or institution. It is crucial that care and treatment decisions related to Parkinson’s disease and any other medical condition be made in consultation with a physician or other qualified medical professional.