International Clinical Council on
Fibrodysplasia Ossificans Progressiva

Tips on how to Prepare for Clinical Trials (for patients)

• Review the informed consent form in detail. Have your family members and primary care doctor also review the informed consent and make sure you are clear on the details of the trial.

• Information that should be included in the informed consent:
  1. Any prior studies (in animals and humans) conducted using the same drug.
  2. Any known side effects of the drug.
  3. How long you will be in the trial.
  4. Will you be getting active drug or Placebo.
  5. What are the outcomes that are being evaluated to assess to efficacy of the drug.
  6. How many total participants planned for enrollment in the trial.

• Need to know how many times you will need to travel to the site and how many caregivers will be able to travel with you. You and your caregivers need to plan scheduled time off to attend those visits.

• Expect the clinical trial to include an imaging component (CT scan), so inform the site investigator if there is concern for you being able to complete the imaging test.

• Have a list of all medical problems, prior surgeries, current medications and drug allergies.