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Ask what the treatment is intended to do, how it compares with your recommended standard care, what is known and unknown about its risks, and what joining would require. Use the questions below to discuss the specific trial and your circumstances with your oncologist and research team; a trial listing alone cannot determine whether a treatment is right for you.
Bring these questions to your appointment, take notes, and ask the team to explain unfamiliar terms in plain language. You can bring someone you trust and take time to review the consent form before deciding.
What is the trial designed to find out?
- What is the main purpose: testing safety or tolerability, controlling or shrinking cancer, improving survival, reducing symptoms, or answering another question?
- What is known about this treatment so far, and what remains uncertain? Why might it help people with my cancer, and why might it not?
- What phase is the study, what are the treatment groups, and could I be assigned to a comparison group or receive a placebo? What would I receive in each group?
- How many people are expected to participate, how long would I take part, and what tests will the team use to judge whether the treatment is working?
- How and when will I hear about the study’s results?
A protocol sets out the study plan, treatments, tests, visits, and procedures. “Experimental” means the treatment is being studied; it does not mean it is more effective than existing care. See the National Cancer Institute’s overview of clinical trials and its guide to what to know about trials.
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How does it compare with my other options?
- What standard treatment do you recommend for me, and why?
- What are my reasonable alternatives—including another standard treatment, a different trial, or focusing on symptom relief?
- Compared with the recommended treatment, what benefit might this trial offer for someone with my cancer, stage, prior treatments, and test results? How certain is that estimate?
- What might I give up by joining now, including access to a standard option or eligibility for another study later?
- How soon do I need to decide? If it is medically safe to take time for a second opinion, what is the risk of waiting?
Ask your oncologist to make the comparison specific to your diagnosis and priorities rather than treating a trial’s possible benefits as a general promise. NCI advises patients to compare trial risks and benefits with standard treatment and ask about other choices; see NCI’s clinical-trial guidance and questions about whether to join a trial.
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What risks are known, and how will the team respond?
- Which side effects have already been observed? How severe can they be, and how likely are they based on the information available?
- What serious or long-term risks remain unknown because fewer people have received the treatment or it has not been studied for as long?
- What tests and check-ins will monitor for side effects? Whom should I contact at night or on weekends if symptoms arise?
- What symptoms or test results could make the team pause or stop treatment, and who makes that decision?
- Could this treatment interact with my medicines or create added risks because of my other health conditions?
A trial treatment may not work better than standard care and could cause more serious side effects. Informed consent, protocol review, and ongoing monitoring are safeguards, not guarantees of safety or individual benefit. Some trials, particularly some phase 3 studies, use a data and safety monitoring board. Ask the team what oversight applies to this study; NCI explains trial risks and safeguards in its clinical-trial overview and guide for participants.
Am I eligible, and what would participation involve?
- Which eligibility requirements do I appear to meet, and what tests or records are needed to confirm them?
- Could my prior treatments, other diagnoses, medicines, age, or current health rule me out?
- How often would I need to come in, how long would visits take, and would I need hospital stays, scans, biopsies, or extra blood tests?
- Would travel to the study site be manageable? Are remote visits or help with transportation or lodging available?
- Who would coordinate my care, and would my usual oncologist remain involved?
Eligibility rules and practical demands depend on the specific protocol. Ask the research coordinator to walk through the actual schedule and requirements, rather than relying on a general description of the trial.
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What could I owe, and what will insurance cover?
- Which treatment costs are paid by the study sponsor, and which are billed to my insurance?
- Could I pay for routine care, extra tests or visits, travel, lodging, meals, or childcare?
- Would the experimental drug itself cost me anything? What happens if my insurer denies a charge?
- Can the research coordinator and insurer confirm coverage and likely out-of-pocket costs in writing before I decide?
Sponsors or insurance may cover many trial-related costs, but patients can still face expenses, including costs tied to additional visits. Coverage and legal requirements vary. Confirm the details with the research team and your insurer; NCI discusses paying for clinical trials.
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What does consent mean, and can I change my mind?
- May I take the consent form home, review it, and return with questions before signing?
- Does it clearly explain the study’s purpose, procedures, treatment groups, risks and possible benefits, privacy, alternatives, and my responsibilities?
- If I start and later decide to leave, how can I do so safely, and what treatment options would remain?
- How will my health information be used and protected?
- Will the team tell me if new information changes what is known about the risks or possible benefits?
Informed consent is a process, not just a signature. You may ask questions and leave a trial, but discuss how to transition your care safely. NCI describes consent and participant rights in its clinical-trial guide, clinical-trial overview, and information on taking part in a trial.
Who will coordinate care and what happens afterward?
- Who is my main contact during and after the trial?
- How and when will I learn whether the treatment is working?
- What follow-up will I need after the study treatment ends?
- If the treatment is not working, the trial closes, or I become ineligible, what happens next?
- If the study allows it, can I speak with someone who has participated?
Post-trial treatment depends on the protocol and your clinical situation. Ask the oncologist and research team to explain the next steps for the scenarios that matter to you.
If no trial is available, ask about routes to an investigational drug
Some patients ask about access to an investigational drug outside a clinical trial. In the United States, expanded access and Right to Try are distinct routes with different requirements; neither means a company must provide the drug. The National Cancer Institute overview describes expanded access as requiring FDA and institutional review board or representative approval and informed consent. Its Right to Try overview lists criteria including a life-threatening illness, no standard treatment available, and inability to join a clinical trial of that drug; the drug must also meet criteria. The NCI page was last reviewed January 13, 2022, so confirm current rules and eligibility with your treating physician and relevant authorities. An investigational drug outside a trial may carry unknown serious risks and may not be covered by insurance. See NCI’s information on expanded access and Right to Try.
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For each option, ask the team to compare the same factors. You do not need numerical estimates if none are available; ask what is known for your situation and what is uncertain.
- Goal of treatment and strength of evidence
- Possible benefit, its likelihood and duration, and uncertainty
- Known and unknown harms, and how they would be monitored
- Effect on symptoms and daily life
- Visit schedule, procedures, and travel
- Eligibility and timing
- Cost, insurance coverage, and potential out-of-pocket expenses
- Who coordinates care and what happens if the option is declined or does not work
If you are still exploring, NCI suggests asking, “Is there a clinical trial that I can join?” Its questions for considering a trial can help you prepare for the discussion.
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