Considering Participating in a Clinical Trial? 8 Questions to Ask

If you find a clinical trial of interest, you may start having some questions as you consider whether to participate or not. For instance, how long will the trial last? How much might you have to travel? Who will cover the medical costs? What are the potential benefits and the potential risks/side effects of the study treatment?

This information is critical for the decision-making process and helps you prepare. If you have any questions, you can reach out to the study sponsors, and get clarification. Researchers understand the need to feel comfortable and in control when volunteering to participate and are more than willing to answer your questions.

Before enrolling, you will also be provided with an informed consent form which is used to confirm your voluntary willingness to participate; in the consenting process, researchers will make sure you have been provided with complete information about the trial and understand what will be required of you as a participant.

Below is a list of questions that you might consider asking about a trial:

1. How long does the trial last?

The study duration can vary widely depending on the research type and the clinical trial phase. Some studies last a few months and others can last up to 4 or 5 years. Even though you, as a volunteer participant, can opt out of a clinical trial at any time and for any reason, your contribution is more valuable and you are more likely to receive any potential therapeutic benefit if you stay until the end of the study.

2. What is the study trying to achieve?

Understanding the objective of the study can help you decide if it is aligned with your own goals and expectations. Is the study testing a new drug or treatment for a specific condition? Or is it exploring the safety and efficacy of an existing treatment for a new population? Understanding the study's purpose can help you determine if you are a good fit for the study and if it aligns with your expectations.

3. Study visits - Where are they, what kinds of tests/treatments are involved, and what will I be expected to do? How will this clinical trial affect my daily life?

Find out if you will have to travel, and if so, how frequently and how far. How many visits to the research site are required? Collect information about the study design and map out how it will impact and fit into your routine. Ensure you are aware of the treatment/drug being tested and how it is administered, and what tests or procedures you may be required to undergo throughout the study. Define your boundaries regarding what you are and are not willing to do, and ensure you feel comfortable with the requirements.

4. What are the potential benefits of participating in the trial?

It is important to understand what potential benefits you may gain from participating in the trial. Will the study offer access to a new treatment that is not yet available to the public? Are there potential health benefits that you may receive? Will you receive close monitoring of your condition and access to healthcare professionals throughout the trial? Understanding the potential benefits can help you weigh the risks and benefits of participating and make an informed decision.

5. What are the potential risks involved?

It's important to understand any possible risks or downsides associated with the trial. In earlier-phase studies, there may be less information available on the safety of the treatment being tested, so there may be more unknowns. Additionally, if you participate in a trial, you may need to temporarily stop other treatments you are currently receiving. The risks are going to vary by study, and the best option is to ask the research team to clarify all of this information for you.

6. What treatment will I receive?

We already mentioned that there are different phases of clinical trials, but there are also many different trial designs, meaning that the way in which they test the effectiveness of the drug differs. Some studies compare an existing standard treatment against the new treatment, while others compare the new treatment against a placebo (something that looks like the study drug but does not contain any active ingredient). In some studies, all participants are given the study drug, and in others, those in the placebo arm may be offered the study treatment afterward if it turns out to be effective. The possibilities are numerous. In order to make these comparisons to determine whether a new drug is effective, in general or in comparison to existing treatments or no treatment, participants are “grouped,” usually according to a process of random allocation called “randomization.” There are different randomization protocols, but statistically speaking, you are equally likely to be put into either group. Each study is unique, so it’s important to understand the treatment you will receive, as well as when and how you will receive it.

7. Will I be able to continue taking my current medications during the trial?

It is important to know whether you can continue with your current medications or if there are any restrictions or limitations. Sometimes medications may interfere with the study treatment or vice versa, which could impact your eligibility for the trial. Make sure you discuss this with the research team before enrolling.

8. Will I be compensated for my time and travel expenses?

Clinical trials may or may not offer compensation for your time and travel expenses. It is important to know what to expect and whether you will be reimbursed for any expenses incurred during the study. This can help you plan ahead and make an informed decision about whether the study is worth your time and effort.