You may hear about clinical trials all the time on the news or perhaps you've heard of a study recruiting patients. Your physician may refer to them as he explains the benefits and risks of your medications. Perhaps you have even participated in a clinical trial. Still only a small percentage of people with Parkinson’s participate in clinical trials. One of the reasons people hesitate is their concern about safety. With any medical treatment or procedure, there is a risk of injury. In clinical trials, there are still many unknown side effects. For that reason, clinical trials have some additional safety systems in place to assure patient safety.
The Institutional Review Board If you decide to participate in a clinical trial, you would likely participate at a hospital, clinic, or doctor’s office close to your home. That hospital, clinic or doctor’s office must report to an organization called an Institutional Review Board, or IRB. Usually the IRB is made up of physicians, nurses, attorneys, statisticians, clergy, and lay people. The IRB’s job is to watch out for the patient safety. It ensures patient safety by:
- Reviewing the study’s plan, or protocol
- Interviewing the investigators
- Reviewing and inspecting the study on a regular basis with the investigators
Frequently, the IRB looking out for your safety is based right in your city or town. Many hospitals have their own institutional review boards. Doctors who conduct research often use IRBs from the hospitals close to them.
My Parkinson’s Info recently interviewed Dr. Phil Daspit, Chairman of the IRB at St. Joseph’s Hospital and Medical Center, in Phoenix, Arizona. This hospital houses the highly regarded Barrow Neurological Institute, and Muhammad Ali Parkinson Center. We asked Dr. Daspit about the role of the IRB in patient safety.
“We make sure the informed consent is readable and understandable, and presents accurately the design and procedures of the study. It is our job to spell risks out in great detail. We make sure the patients understand what’s expected of them, and that they have the opportunity to ask questions, and have all of their questions answered before they sign the informed consent document,” he explained.
Serious Adverse Event Reporting System Any time a patient involved in a study has a “serious and unexpected” health event, the study sponsor must inform the FDA and all other investigators involved in the study. For instance, if a study patient in Florida has a stroke, the investigator in Florida fills out an adverse event report and submits it to the study sponsor. The study sponsor forwards a copy of that report to all other study sites across the country. The individual IRBs across the country also review the data from all of the serous adverse events.
Usually, it is impossible to determine right away if the adverse event was caused by the device or drug. Perhaps the stroke from the example above had nothing to do with the clinical trial. However, the investigators, study sponsor, and the IRBs analyze adverse event data. When an IRB recognizes a trend in adverse events or unexpected harm, it can halt the study.
How Can Patients Learn About the Risks? Dr. Daspit encourages patients to carefully review the study protocol that lists the possible risks before signing the informed consent document.
“Patients have significant rights when it comes to signing the dotted line, not the researchers. If they ask for time to review the protocol, it has to be given to them,” Daspit said. “Patients should never be under pressure. They should have the opportunity to meet with the investigators and study coordinator, and have all of their questions answered.”
For the vast majority of clinical trial participants, they are safe. Your questions are likely your best tool for evaluating safety.
Valuable links:
From ClinicalTrials.gov:
What are side effects and adverse reactions? What are the benefits and risks of participating in a clinical trial? How is the safety of the participant protected? CenterWatch.com’s Questions
