Patient Guide 30 Questions
Questions to Ask Your Doctor
Before Joining a Clinical Trial
30 essential questions to ask your doctor or clinical trial coordinator before enrolling — covering eligibility, risks, costs, and what to expect.
Key Takeaways
- Always ask your own doctor whether a specific trial is appropriate for your medical history.
- Understand whether you could receive a placebo and what the trial phase means for your risk level.
- Verify all costs before enrolling — experimental treatment is usually free but ancillary care may not be.
- You can always withdraw from a trial at any time without affecting your standard medical care.
- Any legitimate trial will have a registered NCT number on ClinicalTrials.gov — always verify it.
◆ Eligibility & Fit ◈ The Treatment & Protocol ⚠ Risks & Side Effects 📅 Logistics & Commitment $ Costs & Compensation ◎ Results & Your Rights
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Eligibility & Fit
5 questions Q1
Am I a good candidate for this trial?
Why ask: Your doctor knows your full medical history and can assess whether the trial is appropriate for your specific situation.
Q2
What are the inclusion and exclusion criteria?
Why ask: Trials have strict eligibility rules. Understanding them upfront saves time and avoids disappointment.
Q3
Does my current medication or treatment disqualify me?
Why ask: Some trials exclude patients on certain drugs or who have received prior treatments.
Q4
Will participating in this trial affect my other treatments?
Why ask: You need to understand whether you must stop current medications or delay other planned procedures.
Q5
Is there a better-suited trial I should consider instead?
Why ask: Your doctor may know of other studies that are a better match for your stage or disease subtype.
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The Treatment & Protocol
5 questions Q1
What exactly will be tested — a drug, device, or procedure?
Why ask: Understanding what is being studied helps you evaluate the potential risks and benefits accurately.
Q2
What phase is this trial? (Phase 1, 2, 3, or 4?)
Why ask: Phase 1 trials prioritize safety in small groups; Phase 3 trials compare against standard treatments in larger populations.
Q3
Is there a placebo group? What are the chances I receive placebo?
Why ask: In randomized trials, you may receive an inactive treatment. Some trials use active comparators instead of placebos.
Q4
Will I know which group I'm in (blinded vs. open-label)?
Why ask: Blinded trials prevent bias but mean you may not know your treatment assignment. Open-label trials reveal the assignment.
Q5
What is the dosing schedule and how is the treatment administered?
Why ask: Know whether treatment is oral, IV, injected, or via device — and how often you'll need to attend clinic.
⚠
Risks & Side Effects
5 questions Q1
What are the known risks and side effects?
Why ask: All treatments carry risk. You're entitled to a complete picture of potential adverse effects before consenting.
Q2
What are the most serious risks?
Why ask: Beyond minor side effects, ask specifically about serious adverse events documented in preclinical or earlier-phase studies.
Q3
How do these risks compare to my standard treatment options?
Why ask: The risk-benefit balance should be evaluated relative to what you would otherwise receive.
Q4
What happens if I experience a serious side effect?
Why ask: Understand the safety monitoring protocols, who to call in an emergency, and whether hospitalization is covered.
Q5
Is there long-term follow-up after the trial ends?
Why ask: Some trials monitor participants for years. Know whether you're committing to long-term follow-up visits.
📅
Logistics & Commitment
5 questions Q1
How many visits are required and how long is each?
Why ask: Clinical trials can require frequent clinic visits. Understand the time commitment before enrolling.
Q2
Where will the trial take place? Is travel required?
Why ask: Multi-site trials may allow local visits, while single-site studies may require travel to a specific hospital.
Q3
How long does the trial last?
Why ask: Trials range from weeks to years. Your life circumstances may affect whether you can complete the full study duration.
Q4
Can I continue my normal activities, work, and travel?
Why ask: Some trials impose restrictions on alcohol, diet, exercise, or travel that may affect your daily life.
Q5
What tests, scans, or procedures will I need to undergo?
Why ask: Beyond treatment, trials often require biopsies, imaging, or blood draws. Know what's involved.
$
Costs & Compensation
4 questions Q1
What costs are covered by the trial sponsor?
Why ask: The experimental drug or device is usually free, but standard care costs, co-pays, or non-trial medications may not be.
Q2
Will my insurance cover trial-related care?
Why ask: Medicare and many private insurers cover routine costs of care in approved trials, but coverage varies. Verify with your insurer.
Q3
Is there compensation for my time or travel expenses?
Why ask: Many trials reimburse travel and parking. Some offer stipends for time and inconvenience. Ask upfront.
Q4
What happens to my coverage if I need treatment for a side effect?
Why ask: Understand who is financially responsible if a side effect requires hospitalization or additional treatment.
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Results & Your Rights
6 questions Q1
Will I be told the results of the trial?
Why ask: Trials don't always share individual results. Ask whether you'll receive your personal data and when the study results will be published.
Q2
Can I continue the treatment after the trial ends?
Why ask: If the treatment works, you may want access to it. Ask about compassionate use programs or post-trial access policies.
Q3
Can I withdraw at any time without affecting my regular care?
Why ask: Withdrawal must always be voluntary and free from pressure. Confirm this explicitly and understand the withdrawal process.
Q4
Who should I contact with concerns or questions during the trial?
Why ask: You should have a direct point of contact — typically a study coordinator — available to you throughout the trial.
Q5
Has this trial been reviewed by an Ethics Board (IRB/IEC)?
Why ask: All legitimate trials must be reviewed and approved by an Institutional Review Board. This is your ethical safeguard.
Q6
Where can I find the official trial registration?
Why ask: Legitimate trials are registered on ClinicalTrials.gov. Ask for the NCT number and verify it online.
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