Before deciding to participate in a clinical research study or clinical trial, it is important for patients and their caregivers to know as much as possible about the study. Download this PDF or keep reading below for a checklist of questions to help guide a discussion with your pulmonary hypertension (PH) health care team about participating in a clinical trial.

Purpose of the clinical trial

  • Why is this clinical trial being done?
  • What phase (or stage) is this clinical trial in?
  • Who is sponsoring and funding this study?
  • Why do researchers believe this new treatment might be effective?
  • Has this treatment been tested before?
  • Have there been other trials like this one? If yes, what were the results?
  • What kinds of patients will be in the clinical trial?
  • How many patients are needed for the clinical trial?
  • How long will the trial take?
  • If the trial is successful, what will the results show?
  • Will I be able to find out about the results of the clinical trial?
  • What has already been learned about the treatment tested in the study and are there any clinical results published?
  • Where can I find out more about this clinical trial?

Who is eligible to participate?

  • Why is this clinical trial a good fit for me?
  • What other treatment options do I have?
  • Will my treatment and care change if I join this study? If yes, how?
  • How will the test in this trial compare to the test that I would have as part of my routine care?
  • Are there other clinical trials that might be a good fit for me?

Potential risks and benefits

  • How could this trial help me?
  • What are the potential short-term and long-term side effects of this treatment?
  • How do the possible risks and benefits of this clinical trial compare with my standard of care? How do they compare with other potential experimental treatment options?
  • Who has reviewed and approved this study for protecting participants rights and safety?
  • What steps will be put in place to monitor my safety?
  • How will I know if the treatment is working?
  • If the treatment works for me, can I keep using it after the trial ends?

Practical concerns

  • What will I have to do if I join this trial?
  • Will I need to come to the hospital or clinic for specific tests or treatments? Is yes, how often?
  • How will this study affect my daily life?
  • Where will I receive my medical care?
  • Who will be managing my care? Will I be able to see my own PH care team?
  • Can anyone find out whether I am participating in this clinical trial?
  • Can I talk to other people who are participating in this trial?
  • Will I receive any follow-up care after the study has ended?
  • Do the researchers/clinicians have any financial or special interests in this clinical trial?
  • Who do I contact if I have questions during the trial?

Financial concerns

  • Will I have to pay for any part of the treatment during the study?
  • If yes, what will the charges likely be?
  • Will there be any travel or childcare costs that I will need to consider while participating in this study?
  • Will my health insurance cover any of the expenses from participating in this trial?
  • Who can help answer any questions from my insurance company about this clinical trial?

In this 12 1/2-minute video, Christopher S. King, M.D., discusses how to talk to your doctor about getting involved in clinical research and explains the informed consent process.

Melanie K. Nies, M.D., addresses why pediatric research is important, how it is different than research in adults, and things to consider when deciding on pediatric research for your child in this 11-minute PHA Classroom video.