Medically reviewed by Jenny Blair, MD
So you’re thinking about joining a clinical trial? Maybe you’ve searched for and found some that you’re interested in participating in. The next step? Having a lengthy discussion with your doctor. It’s important to understand what you’re signing up for and how participating may affect you.
Start by asking your gastroenterologist these key questions about joining a clinical trial.
1. Do you think I’m a good candidate for a clinical trial?
Each clinical trial has its own set of eligibility criteria, including things like age and gender, and which medication you currently take or whether or not you’re in remission. Talk with your doctor about how well you’re currently managing, and get their opinion on whether or not you should join a clinical trial.
2. Do you have any recommendations for clinical trials that I may be eligible for?
You may have done your research and identified a few trials you’re interested in before you meet with your doctor. If not, you can work together with your care team to search all available clinical trials through the Crohn’s & Colitis Foundation Clinical Trial Finder to identify which ones might be a good fit for you.
3. What are the potential risks of participating?
Clinical trials are conducted to help test and ensure the safety and effectiveness of a new treatment before it’s approved by the FDA for the rest of the human population. That means that, at the time of the trial, the safety and effectiveness may not yet be fully understood—so there is a certain level of risk that you take when you sign up. It’s important to fully understand the potential risks before you agree to participate.
4. What are the potential advantages of participating in a clinical trial?
For starters, you’re helping to move the needle forward in IBD treatment. Not everyone with IBD responds to medication, and those who do may lose responsiveness to treatment over time. So there’s an ongoing need to develop new treatment options to help everyone with IBD control their disease. What’s more, clinical trials give you advanced access to new drugs that may help you gain better control of your condition. Regardless, before you sign up, it’s important to carefully talk through and weigh the pros and cons of participating in a clinical trial.
5. If I do decide to participate, will I still see you for follow-up care as usual?
Participation in a clinical trial is not a substitute for your routine medical care. It’s important to make sure you stay on top of your regular doctor visits so that your doctor can monitor your condition as usual. Therefore, it’s important to make sure your doctor is on board with your decision to participate and can keep any trial participation in mind while overseeing the rest of your medical care.
6. What are next steps if I decide to sign up?
Once you and your doctor have identified and agreed upon a particular trial you’re considering signing up for, the next step is to find the nearest trial site to you and contact the site coordinator to set up a consultation. That’s where you’ll have an opportunity to discuss the process of that particular trial at length with the coordinator, who can also answer any questions you may have before you sign consent forms agreeing to participate.
7. What can I do if I change my mind about participating before the trial is over?
Your participation in a clinical trial is voluntary. Even after you meet with the research coordinator and sign consent forms, you can still drop out at any time.