It’s a big decision to take part in a migraine clinical trial, so it’s important that patients and caregivers understand the benefits and risks before enrolling. There are many reasons that people choose to volunteer for clinical research, but it’s important to weigh these against potential risks.
Top Benefits of Joining Clinical Trail
Access to care
People who take part in a migraine clinical trial receive access to the latest treatments in development. For many patients looking for options, this is a real benefit. In fact, according to a CISCRP survey of 2,194 former clinical trial participants, 44% of people surveyed cited “obtain better treatment” when asked to share their top reasons for participation. In some cases, patients are able to continue taking the drug after the trial is over, as well. Also, in many cases, patients receive either the standard of care or the investigational drug, removing the risk of receiving a placebo.
Quality of care
Patients in clinical trials report a high level of personalized care while participating in research. While trials may require more office visits than normal or more tracking of symptoms, this extra time spent on health can mean a higher quality of care.
Treatments are often given at no cost to patients; in many cases, volunteers are compensated for their time, travel or participation in general. The amount of payment has to do with the phase of the migraine clinical trial — earlier trials such as Phase I pay more (nearly $2,000 on average) because the treatments being studied are not as well-understood. To find a paid clinical trial, you’ll likely need to find a few trials for which you may qualify, then contact the sites to learn about potential payment.
Helping advance science for future generations
The goal of clinical trials is to discover new, better treatments (and cures) for the condition being studied. This means that, if successful, patients with that condition in the future will have better options than current patients. This is an important motivator for many patients today. In the CISCRP survey referenced above, nearly half of participants cited “help advance science, treatment of disease/condition” as one of their top reasons for participation.
Protections for Patients
Clinical trials also come with some degree of risk. There is a chance that the treatment being studied might not work as expected. It might not be better than the standard of care. The study drug could also cause an unexpected side effect, especially in earlier phase trials.
There are several protections in place for patients who take part in clinical trials:
- An Institutional Review Board ensures that trials are ethical and that participant rights are protected. The FDA provides oversight for clinical trials testing new drugs or devices.
- Participant rights include informed consent, meaning that volunteers are given all the facts about a trial and can ask any questions.
- How long will the study last?
- What is the goal of the study?
- Am I reimbursed for my expenses?
- Does the study include a placebo?
- How will I receive the treatment?
- If it works for me, can I continue taking the study drug after the trial?
- Is my privacy protected?
- What can I expect at each study visit?
- If I leave the study early, what happens?
- What happens if my condition gets worse or I am injured during the trial?
- Who is conducting the study?
- What did previous studies find out about the treatment? Have the results been published?
- What are the potential risks and benefits of the study drug?
- Will I receive follow-up care after the study?
- Will I receive results of the trial?
- After signing an informed consent, a participant can leave a clinical trial at any time, for any reason. If unexpected risks emerge during the trial, patients have a right to be informed about them and be removed from the study.
- Special protection is given to children who participate in trials. Often, both parents must give legal consent, and children over age six need to agree to take part.