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Clinical Trial Questions To Ask

Related Article: Questions To Ask Before Joining A Clinical Trial

Included below is a list of suggested questions to ask about a clinical trial in which you're interested. The questions have been divided into four separate categories.

You may find that not all of the questions will apply to you or the trial that you are considering. You can prioritize the questions in their order of personal importance by designating a number to the left and clicking "Reorder" at the end of the list. Feel free to print the questions and take them with you to interviews about the trial.

You should be able to find the answers to most questions from the doctor who oversees the trial, the informed consent or the trial protocol. If the questions relate to how a trial will affect your daily life, speak with one of the trial's nurses.



Questions About The Trial

(To be numbered 1 - 20 in importance to you)

What is the purpose of this study?

Where is the trial site located? (The trial site is where you will go to participate in the trial.)

Who is sponsoring/paying for this study?

Who are the researchers and what are their backgrounds?

How much experience does the research team have in conducting clinical trials?

Who do the researchers work for?

Who has reviewed and approved this trial?

Who will benefit financially from the results of the study?

Why do you believe this treatment will be effective?

What is the current trial phase?

How long has this trial been going on?

Have you conducted similar trials with drugs like the one in question in the past? If so, what were the results?

How long is the trial expected to continue?

Is anyone being paid to get me into the trial?

Are people paid to participate in the trial? If so, how much and when?

How many people are in the trial?

Who will I speak with during the trial process if I have questions or complaints?

Will I have to be hospitalized at any time during the trial? If so, where? How often? For how long? Does the trial cover these costs?

What are the markers that will be used to determine if the trial is working? How often will I be informed about where my markers are?

Who is on the Institutional Review Board and what are their credentials, professional affiliations and medical specialties.

The Risks

(To be numbered 1 - 5 in importance to you)

How is patient safety being monitored and recorded during the trial?

Have there been any FDA concerns or investigations about the safety of this trial?

About the possible immediate and long-term side effects of the treatment or drug being studied:

  • What are they?
  • How often do they occur?
  • Is there anything that I can do to minimize these risks?

How do the possible risks and benefits compare with the standard or approved treatments for my condition?

If my health should be harmed or injured as a result of the trial, what treatment and care am I entitled to? In what setting? Under whose care? Would all costs be completely covered by the trial?


(To be numbered 1 - 7 in importance to you)

What tests, treatments, or other charges are not covered by this trial?

How do the costs of the trial that I am expected to bear compare to the standard treatment for my condition?

Is my insurance company likely to cover these additional charges?

If I need help getting my insurance to cover these costs, who do I talk to for supporting evidence and arguments?

Have you had direct billing experience with my insurance company for this trial? If so, what were the results?

Are other insurance companies covering these additional costs? If so, which ones?

Does the trial cover reimbursement for personal expenses related to the trial, such as time off from work, loss of income, travel expenses, lodging, meals, and child-care costs? If these types of costs aren't covered, does the trial have referrals to resources that can help with the finances?

Personal Questions

(To be numbered 1 - 20 in importance to you)

Am I eligible for participation in this trial?

What are the possible or expected benefits for me personally?

How will I know if the treatment is working?

If the drug or treatment works, will I be able to continue to receive it after the trial is finished? Will I be able to get the drug if all I received during the trial was a placebo?

Will I be given the results of the trial? If so, when?

How do you compare the tests I would receive if I join the trial to the tests I would have to undergo in any event because of my health condition?

During the trial, will I at least receive the standard treatment for my condition? If not, is there a possibility that I will receive a placebo during the trial?

Will any of the treatments or procedures be painful? If so, how will the pain be controlled?

What are my other treatment options and what are their benefits and risks? How do they compare to the treatment being studied?

Will I be able to continue taking my regular medications? If not, what impact may that have on my condition? Can I take nonprescription (over-the-counter) drugs while I am in the trial? Complementary therapies?

What activities, medications, or other treatments should I avoid during the study?

How may the study affect my daily life?

How often will I have to travel to the study site?

What is the estimated length of time for my participation in the trial?

Will I still be under the care of my primary care physician or specialist during the trial?

What functions will my primary care physician have to perform?

What kind of long-term follow up care is provided by the study?

Will I be informed of the results of the trial?

What steps are in place to protect my confidentiality during the trial process, and after the trial is complete?