What Questions Should I Ask Before Joining a Clinical Trial?

By: David Grew MD MPH

"Informed consent is a process, not just a signature on a form."

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Joining a clinical trial is a personal decision. For some patients, a trial may offer access to a promising treatment approach or a way to contribute to future cancer care. But before saying yes, it is important to understand what the study is testing, what participation involves, and how it may affect your daily life.

The National Cancer Institute notes that informed consent is meant to help people understand the purpose of a trial, the possible risks and benefits, and what alternatives exist before deciding whether to join.

Below are some of the most important questions patients may want to ask.

1. What is the goal of this clinical trial?

Not all clinical trials are trying to do the same thing. Some are testing whether a new treatment works better than standard treatment. Others are studying side effects, quality of life, dosing, or whether a treatment can be given more safely or conveniently. Treatment trials look for better ways to treat cancer, while other trials may focus on prevention, screening, supportive care, or quality of life.

A simple starting question is:

What is this study trying to learn?

That question can help patients understand the bigger picture before getting into the details.

2. Why might this trial be a good fit for me?

A clinical trial may be designed for patients with a certain cancer type, stage, treatment history, biomarker, or overall health status. Trials have eligibility rules so researchers can study the treatment in the right group of patients and protect safety. Each trial has a protocol with eligibility criteria that describe who can join.

Patients may want to ask:

• Why do you think I may qualify?
• What features of my cancer make this trial relevant?
• Are there reasons I might not be eligible after screening?

3. What treatment will I get if I join?

This is one of the most important questions.

Some studies compare a new treatment with standard treatment. Others add a new drug to standard care. Some trials randomize patients into different groups. In randomized trials, a computer assigns participants to groups, and patients do not choose the group themselves.

Ask clearly:

• What are the treatment groups?
• Is there randomization?
• Will I definitely receive active treatment?
• What is the current standard treatment outside the trial?

Understanding this helps patients compare trial participation with usual care.

4. What are the possible benefits?

A clinical trial may or may not help the individual patient. People in clinical trials may receive new treatments before they are widely available, but researchers do not know in advance whether the new treatment will be better than standard care.

That is why a useful question is:

How might this trial help me, and what are the uncertainties?

The answer should include both the possible upside and the fact that there may be no personal benefit.

5. What are the risks and side effects?

Every trial has risks. These may include side effects from the treatment itself, extra blood draws, scans, biopsies, travel, time, or other burdens. The informed consent process should explain known risks and side effects as well as any expected discomforts.

Patients should ask:

• What side effects are already known?
• What side effects are still uncertain?
• Are serious side effects possible?
• How are side effects monitored and treated?

6. What extra visits, tests, or procedures are required?

A trial may involve more than just treatment. Patients may need extra scans, lab work, clinic visits, questionnaires, or biopsies. People in clinical trials may need more tests and more doctor visits than they would with standard treatment alone.

This matters because even a promising trial can be hard to participate in if the logistics do not fit a patient’s life.

Ask:

• How often are visits?
• Will I need extra scans or bloodwork?
• Are there research biopsies?
• How long will participation last?

7. What costs are covered, and what costs might I still have?

Cost is an important question, and patients should ask it directly. Routine patient care costs are often covered by health insurance, but the trial sponsor may cover some research-related costs; what is covered can vary.

Questions to ask include:

• Which costs are billed to insurance?
• Which costs are covered by the sponsor?
• Are travel or lodging costs ever covered?
• Who can help me review the financial details?

8. Can I leave the trial later if I change my mind?

Yes. Joining a clinical trial is voluntary and that participants may leave at any time.

Even so, patients should still ask what happens next if they stop participating:

• Would treatment stop immediately?
• Would there still be follow-up visits?
• What care would I receive after leaving the study?

9. How will this trial affect my daily life?

This question often gets overlooked, but it matters a lot. A trial may affect work, caregiving, travel, fatigue, scheduling, and quality of life. Quality-of-life and supportive care issues are legitimate parts of clinical research and clinical decision-making.

Patients may want to ask:

• Will I be able to work?
• How much travel is involved?
• How often will I need someone to come with me?
• Are there restrictions on food, activity, or other medications?

10. What are my other options if I do not join?

A patient should never feel pressured into a trial because they do not understand the alternatives. The informed consent process is supposed to include a discussion of appropriate alternative treatments or procedures that may be helpful.

A very important question is: What would you recommend if I decide not to join this trial?

That question helps place the trial in context.

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Clinical trials are an important part of improving cancer care, but they are also real medical decisions with real tradeoffs. Asking good questions does not mean a patient is being difficult. It means they are trying to make an informed choice. Informed consent is a process, not just a signature on a form.

If you are thinking about joining a clinical trial, bring your questions to your oncology team and ask them to walk you through the trial in plain language. Understanding the purpose, logistics, risks, and alternatives can make the decision clearer.

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FAQs:

Do I have to decide about a clinical trial right away?
No, not usually. Informed consent is meant to give patients time to learn about the study and ask questions before deciding. The exact timeline may depend on the medical situation, so patients should ask their care team how much time they realistically have and whether waiting could affect treatment options.

Can I bring a family member or friend to a clinical trial discussion?
Yes. NCI encourages patients to ask questions and understand the study before enrolling, and many patients find it helpful to bring another person to listen, take notes, or help think through the decision. If you are considering a trial, ask your care team whether a support person can join the discussion or visit.

Will I always know whether I am getting the new treatment in a trial?
No. In some trials, patients know which treatment they are getting. In others, especially randomized or blinded studies, they may not. Patients should ask whether the study is randomized or blinded and how treatment assignment works before enrolling.

Is it okay to get a second opinion before joining a clinical trial?
Yes. Public patient guidance from the American Cancer Society supports asking questions and getting enough information to make a decision, and second opinions are a common part of cancer care. If you are unsure, ask your care team whether a second opinion would be reasonable in your situation.

If I join a trial, will my regular cancer doctor still be involved?
Sometimes, yes, but it depends on the trial. Some studies are run within a patient’s usual cancer center, while others involve a separate research team or outside site. Patients should ask who will manage day-to-day care, whom to call about side effects, and how information will be shared with their regular oncology team.