Questions to Ask Before Participating in a Clinical Trial

By Dora Mugambi, a Clinical Trial Diversity Consultant

“Don’t keep things to yourself. Most people don’t know what they need to know about a clinical trial”

For many, “experimental” is what may come to mind when hearing about a clinical trial, which makes the prospect scary. However, for someone who has a rare disease without a treatment, the course ahead may already be filled with so many unknowns. Participating in a clinical trial can offer the opportunity to get access to care with doctors who are likely experts in the studied disease. But the key is, do not be afraid to ask.

As a clinical researcher, I have seen many people who are timid about asking questions. I try to coach them that it is in their best interest to ask any and all questions and learn as much as they can.

There is some evidence that doctors do not routinely offer the option of a clinical trial to their patients, unless they feel there are limited treatment options. People of color are still less likely to be offered the opportunity to explore a clinical research study. Often, it may be the doctor is not familiar with the studies available in a rare disease, and so are not prepared to bring it up to their patients. But that does not mean that you can’t your doctor questions about participating in a particular study you have found and are interested in.

I have seen people who have been reluctant to bring up questions to their doctor because they perceive their questions will only “bother the doctor” or that he or she doesn’t have enough time to explain or answer all your questions.

However, when you apply to a study, the doctors and nurses at the study team are required to answer all your questions, and will take the time to explain all the requirements and expectations for participating in the clinical trial.

You must feel comfortable asking your questions and voicing any concerns. Health Authorities like the FDA mandate that a participant in a clinical study must understand each component and be given enough time to make the decision to participate. Therefore, your questions are expected, and welcomed. You an also take the time to discuss participation with your doctors, family members, or a legal advisor.

Unsure of what to ask?

HERE Are A FEW TOPICS YOU MIGHT haVE THOUGHT ABOUT BUT WEREN’T SURE HOW TO ASK:

Commitment: how long is the study, and how frequently are in-person visits required. Also, you may want to know if you can change your mind and withdraw from the study for any reason.
Cost: usually all the visits, therapies and tests are of no charge to the participant. Many studies also include reimbursement for travel to get to in-person visits (including flights, if needed).
Treatment: if it is a study where some participants are given the study drug but others are given a placebo—a look-alike drug but with no active ingredient, a “sugar-pill”—most studies in rare diseases will allow you to take your regular medications so that even if you get the placebo, you are still getting the same care. But it is important to tell the study doctor all the medications you are taking and to discuss whether you can continue taking them if you participate.

The study team or the doctor at the study center will go over these topics and others with you, which will be covered in the Informed Consent document you will be given.

Your best champion is you. You should always feel comfortable discussing your options, including clinical trials with your doctors. Clinical trial researchers are experts in studying the disease, and will want to hear your questions and thoughts about participating in the study.

So, don’t hesitate to ask.

HERE ARE SOME QUESTIONS YOU MAY WANT TO ASK THE STUDY TEAM BEFORE YOU AGREE TO TAKE PART IN A CLINICAL TRIAl:

What is the goal of the study?
What are the requirements for participation?
What type of medication is being tested? How does it work?
How long is the trial expected to last?
How often will I have to visit the study center?
Will I have to pay for the visits or medication? Will I be reimbursed for lodging, transportation, and parking?
Does the study have a placebo (non-drug) group? What happens if I get the placebo instead of the test medication?
Can I stay on my current medication during the clinical trial?
Can I still see my regular doctor?
Can I leave the study if I want to? What will happen if I leave the study early?
How will my personal health information be used and shared?

IF YOU WANT TO LEARN MORE ABOUT THE MEDICATION ITSELF, HERE ARE SOME ADDITIONAL QUESTIONS YOU MAY WISH TO ASK:

If I do well on the study drug, will I be able to keep taking it after the study is over?
What phase of study is the drug in? How many more steps until it gets approved?
How will I know if the drug is working?
Who should I contact at the study center if I have questions about the medication?

What has to happen before you can take part in a clinical trial? First, you will need to meet certain requirements. These may have to do with your diagnosis, the time since your diagnosis, what symptoms you have, and what medications and other treatments you may have tried already. In order for the study results to be reliable, it is important that everyone in the trial meet the same requirements.

The research team will interview you to make sure you meet the study criteria. Next, they will present you with an informed consent document that provides all the information you need to know about the study. The document will outline what you must to do to take part in the study (for example, attend study visits and undergo testing). It will also inform you about the potential side effects and risks of the study medication. If there is a placebo (non-active drug) group in the study, you will find out about your chances of receiving the placebo instead of the study drug. The informed consent document will also tell you whether you can continue taking your current medications while you are in the study.

When you sign the informed consent form, you give the researchers permission to ask you details about your medical history and review your records. They can then give you the tests and examinations that will confirm whether you are eligible for the study. If you meet all the requirements, you will be enrolled in the study and given a schedule for treatment and follow up.