Questions to Ask

Before participating in a clinical trial, you should learn as much as possible about the drug and the clinical trial. Make sure you ask any questions you have so you feel well informed and comfortable with your decision.

Below are some sample questions that you may want to ask the study investigator. It’s sometimes helpful to print out your questions and bring them with you to the clinical site. To do this, download the PDF of the sample questions. [link to PDF file]

QUESTIONS ABOUT THE RESEARCH

  • What is the purpose of the study?
  • Who is sponsoring the study?
  • Who has reviewed and approved this study?
  • Is the trial registered on a national database (e.g. clinicaltrials.gov or clinicaltrialsregister.eu)?
  • Has the clinical trial been filed with your national regulatory agency (e.g. FDA, EMA, Health Canada, etc.)?
  • Will the trial be monitored by an independent safety board?   
  • Why does the research team think the treatment/drug will work?

QUESTIONS ABOUT YOUR PARTICIPATION IN THE STUDY

  • Where is the study site?
  • What kinds of therapies, procedures, and/or tests will I have during the trial?
  • Will they hurt? If so, for how long?
  • How long will the study last?
  • How often will I have to go to the study site?
  • Who will provide my medical care after the study ends?
  • Will I be able to take my regular medications during the trial? Do I need to avoid any medications?
  • What medications, procedures, or treatments must I avoid while in the study?
  • Will I have to be in the hospital during the study? If so, for how long?
  • Will I be able to find out the results of the trial?
  • Will I have to pay anything to participate in the study?

SOME QUESTIONS ABOUT RISKS INCLUDE:

  • What is known about the potential adverse effects and tolerability of the treatment?
  • What are the possible immediate and long-term side effects?

Additional considerations

While there will always be risks associated with participating in a clinical trial, proper oversight ensures that these risks are reduced as much as possible. Clinical trials that are conducted according to international standards are reviewed by national regulatory agencies (e.g. U.S Food & Drug Administration; European Medicines Agency; Ministry of Health, Labour & Welfare) and are monitored by ethics committees or institutional review boards (IRBs). Ethics committees review, approve, and monitor each clinical study. Their role is to make sure the study is ethical and that the study participants’ rights, welfare and safety are protected. Any clinical trial you are considering participation in should be conducted by a qualified investigator, at a qualified clinical site, and should be monitored by a local ethics committee or IRB.

You should never feel pressured to participate in a clinical trial, and you should never have to pay in order to receive study medication.   

Should you decide that participating in a drug clinical trial is not for you, there are other options available for you to participate in research. Consider participating in the IFOPA’s FOP Registry, which is a vital tool for advancing our understanding about FOP.  Or consider participating in the IFOPA’s FOP Biobank, which collects saliva, urine, blood, and/or teeth from people with FOP (or their family members) for research purposes. 

Finding a Trial

To see a complete list of FOP clinical trials, including those actively looking for study participants, visit our Ongoing Clinical Trials page [link to this page]. Check the website frequently, as the page is regularly updated with new trial information. You can also visit the National Institutes of Health (NIH) site which contains a comprehensive list of ongoing and completed clinical trials.

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