While we advocate for the value of participating in clinical trials, it is really important to make sure you ask questions to work out all your options, and what participation in a clinical trial will involve and mean for you. Not every trial may suit your risk profile, personal circumstances or choices. So we encourage you not to blindly say yes to a trial, but to take the time to find out if a trial is right for you.

Researchers expect that you will have questions, so you should not be worried about asking. No question is a silly question. It is better to ask questions than to take part in a trial you do not fully understand.

So to get you started, here is a list of the questions we think you should be able to answer about a trial. If there are any you can’t answer, then please ask the researchers before you sign up (provide consent). If already in a trial and can’t answer then, then you can still ask the researchers at any time. It is never too late to ask.

 

The Study

  • What is the purpose of the study?
  • What health conditions must I have? Are there any particular conditions that would exclude me?
  • Why do you think the approach being tested may be effective? Has it been tested before?
  • How will it be decided which treatment I get in the trial? Do I have a choice?
  • How many volunteers will be in the trial?
  • Who is sponsoring the study?
  • Are you being paid to run this study? Will you personally benefit in any way from the study if the results are positive?
  • Who has reviewed and approved the study? How do I get in touch with them if I have questions about the trial, trial researchers or its approval?
  • What is the experience and medical credentials of the researchers and other study personnel?
  • How will the study results and my safety be monitored?
  • How long will the trial last?
  • If the treatment I am getting is blinded, when will I find out what treatment arm I was on?
  • Will I get told my results or the outcome of the trial?

Possible Risks and Benefits

  • How risky might this research be? For example, has this intervention been researched before? How scientifically rigorous has preclinical testing been? Can supportive research papers be provided? If a clinical trial of a medicine, what phase of clinical trial is it?
  • What are the possible short-term and long term benefits of the trial or the intervention being studied?
  • What are the possible short- and long-term risks, such as side effects??
  • What other treatment options are available?
  • How do the possible risks and benefits of the trial compare with my current treatment, or other options?
  • What will happen if I suffer a serious side effect as a result of the trial?
  • Can I withdraw from the study at any time?

Participation and Care

  • What will I have to do (my responsibilities) if I take part?
  • What kinds of treatment, medical tests, or procedures are involved? How often will I receive the treatments, tests, or procedures?
  • How often will I need to visit the researchers and what will I need to do between visits?
  • Is there anything I am not allowed to do while I am in the trial?
  • Are there any medications or supplements I shouldn’t take while I am in the trial?
  • Will treatments, tests, or procedures be uncomfortable or painful? If so, how can I be made more comfortable or have the pain controlled?
  • How do the tests in the study compare with what I might receive outside the study?
  • Will I be able to take my regular medications while in the clinical trial? What happens if I need a new medication/treatment during the trial?
  • Where will I come for my medical care? Will I need to be hospitalized? If so, for how long?
  • Who will be in charge of my care? Who should I contact if I have a problem?
  • Will I be able to continue to see my own doctors? Will you be informing my usual doctors what is happening in the trial?
  • How long will I need to stay in the study? Will there be follow-up visits after the study?
  • Will I have access to the medicine after the trial is over?
  • If something goes wrong in the trial, how will I be cared for? Who will cover those costs?
  • Who will I visit for my ongoing medical care after the trial is finished?

Personal Issues

  • I don’t live in the city/state/country that you are running the trial in. Am I still able to participate?
  • How might the trial affect my daily life?
  • Are you able to help me explain the time off I need to my employer, school, etc?
  • What will I need to pay for?
  • Will I be paid to take part in the trial? Will any of my expenses be covered? For example, can you help with covering taxi’s/transport, car parking, meal & accommodation expenses, etc for visits if needed?
  • Will participating in a trial affect my life insurance and medical insurance status? Am I covered by insurance if something goes wrong because of the trial?
  • Who will get to see my medical records, and how is my privacy protected?
  • Do I need to tell my GP about the trial, or do you do that?
  • What support is available for me and my family?
  • Can I talk with people already enrolled in the study?

 

Are there any questions we missed? Let us know in the comments or via email/social media. Your experience asking questions may just help the next person evaluate if a trial is right for them.

 

Would you like a PDF copy of these questions to take along to your visit?  Download NOW.

©2021 Research4Me | Disclaimer | Privacy Policy | Terms & Conditions | Developed By: www.wphelpbuddy.com

CONTACT US

We're not around right now. But you can send us an email and we'll get back to you, asap.

Log in with your credentials

or    

Forgot your details?

Create Account