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Before deciding whether to try an experimental cancer treatment, ask what the study is designed to learn, how it compares with your recommended standard care, what risks and burdens it involves, and what happens if you join or decline. Bring these questions to your oncologist and the clinical-trial team; the answers depend on your diagnosis, treatment history, the specific study, and your priorities.
Start by understanding what the study is testing
“Experimental” does not mean more effective. A clinical trial may be testing safety, looking for signs that a treatment controls or shrinks cancer, comparing approaches, or answering another research question. Ask the team to explain the purpose and design in ordinary language, including what is known so far and what remains uncertain.
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- What is the main purpose of this trial?
- Why do researchers think this treatment might help people with my cancer? What are the reasons it might not help?
- What is known about this treatment in people so far, and what remains unknown?
- What phase is the study, and what treatment groups are there?
- Could I be assigned to a comparison group or receive a placebo? What treatment would I receive in each group?
- How long would I participate, what tests and visits are planned, and how will the team assess whether the treatment is working?
- How and when will I learn the study results?
The protocol sets out the study plan, treatments, tests, visits, and expected procedures. Ask to review the parts that affect your care. The National Cancer Institute (NCI) also recommends asking about the trial’s purpose, duration, testing, and how results will be assessed and shared: questions to ask about clinical trials.
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Compare the trial with every reasonable care option
Ask your oncologist to compare the study with the care they recommend for your specific cancer, stage, test results, and prior treatments—not with standard treatment in the abstract. Include other reasonable choices, such as another standard treatment, a different trial, or symptom-focused care. If time is medically safe, ask whether you can consider the options or get a second opinion before deciding.
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- What standard treatment do you recommend for me, and why?
- What other options are reasonable in my situation, including another trial or focusing on symptom relief?
- What benefit might this trial offer compared with the recommended standard treatment, and how certain is that estimate for someone like me?
- What could I give up or make harder by joining now, including access to a standard option or eligibility for another study later?
- How quickly do I need to decide? What is the medical risk of taking time for a second opinion?
Compare each option on the same points: its intended goal, evidence and uncertainty, potential benefit and its likely duration as explained for you, known and unknown harms, impact on daily life, schedule and travel, cost, and the next step if it does not work or you decline it. Ask the oncologist to explain differences that matter to your own goals. NCI guidance on clinical trials and treatment choices and finding and considering a trial can help frame that discussion.
Ask about known risks, unknowns, and safety plans
A trial treatment may be less effective than standard care or cause more serious side effects. The risks known so far may not tell the whole story, especially if fewer people have received the treatment or follow-up has been shorter. Ask for specifics about the treatment and the study’s plan for responding to problems.
- Which side effects have already been seen? How severe can they be, and how likely are they based on the evidence available?
- What serious or long-term risks are still unknown?
- What tests and check-ins will look for side effects?
- Who should I contact if symptoms appear at night or on a weekend, and what symptoms require urgent care?
- What could make the team pause or stop treatment, and who makes that decision?
- Could the study treatment interact with my medicines or be riskier because of another health condition?
Informed consent, review of the study protocol, and ongoing monitoring are protections—not guarantees of personal benefit or zero risk. Some trials, including some phase 3 studies, use a data and safety monitoring board. Ask what safety oversight applies to this specific trial. NCI explains clinical trial risks and side effects and how participant safety is monitored.
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Find out whether you qualify and what participation requires
Eligibility depends on the actual protocol. The team may need to review your records and run tests before it can confirm whether you qualify. Ask about the practical schedule at the same time; frequent visits, scans, biopsies, or blood tests can affect whether participation works for you.
- Which eligibility requirements do I appear to meet, and what records or tests are needed to confirm that?
- Could prior treatment, another diagnosis, my medicines, age, or current health keep me from enrolling?
- How often will I need to come to the study site, how long will visits take, and could I need hospital stays?
- What extra scans, biopsies, blood tests, or other procedures are required?
- Are remote visits possible? Is help available for transportation or lodging?
- Who coordinates my care, and will my usual oncologist remain involved?
Ask the research coordinator for the visit schedule and procedures in writing, then consider the travel and time commitments alongside medical factors.
Clarify costs and insurance before agreeing
Who pays for a clinical-trial expense can depend on the study, the service, your insurer, and where you receive care. Some costs may be paid by the sponsor or insurance, but out-of-pocket expenses can occur, including costs linked to extra visits. Ask the study team and insurer to clarify your own coverage before you decide.
- Which treatment, tests, and visits are paid for by the study sponsor, and which will be billed to my insurance?
- Could I pay for routine care, extra tests, travel, lodging, meals, or childcare?
- Will the experimental drug itself cost me anything?
- What happens if my insurer denies a charge, and can the coordinator and insurer confirm coverage in writing before I enroll?
NCI provides an overview of clinical trial costs and payment. Do not rely on a general description to determine your personal coverage.
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Informed consent is a process, not just a signature. You can ask questions and request time to review the form before signing. It should describe the study’s purpose, procedures, treatment groups, risks and possible benefits, alternatives, privacy, and what participation requires.
- Can I take the consent form home and return with questions before signing?
- What does it say about the study plan, possible benefits and risks, alternatives, privacy, and my responsibilities?
- If I start and later change my mind, how do I leave safely, and what care 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 risks or benefits?
Participants may leave a study at any time. Ask the team how withdrawal would affect treatment and follow-up so you can plan a safe transition. See NCI’s explanation of informed consent and taking part in a trial.
Ask what happens during and after the trial
Before enrollment, understand who will answer questions, how your care will be coordinated, and what the possible next steps are if the treatment is not working, you become ineligible, or the trial closes.
- Who is my main contact during and after the trial?
- How and when will I find out whether the treatment is working?
- What follow-up will I need after treatment ends?
- If the treatment is not working, the trial closes, or I become ineligible, what happens next?
- Can I speak with someone who has participated in this trial, if the study allows it?
Post-trial treatment depends on the protocol and your clinical circumstances. Ask the study team to explain the plan for each possibility you are concerned about.
If the drug is offered outside a clinical trial
In the United States, expanded access and Right to Try are distinct pathways that may allow certain patients to seek an investigational drug outside a clinical trial. They have different requirements and safeguards; neither means a company must provide the drug. NCI’s overview says expanded access requires FDA and institutional review board or representative approval and informed consent. Its Right to Try overview describes criteria that include a life-threatening illness, no standard treatment available, and inability to join a clinical trial of the drug; the drug must also meet criteria.
That NCI page was last reviewed January 13, 2022, so confirm current rules and eligibility with your treating physician and relevant authorities. Access outside a trial can involve unknown serious side effects, and insurance may not cover the treatment. Read NCI’s overview of expanded access and Right to Try and ask how costs and care would work in your case.
Make the appointment easier to use
Bring a written list, take notes, and consider bringing someone you trust to listen and help remember the answers. If a term or answer is unclear, ask the oncologist or research team to explain it in everyday language. NCI suggests asking directly, “Is there a clinical trial that I can join?” and “Would a clinical trial (research study) be right for me?” See its questions to ask your doctor about clinical trials.
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