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Basic information about participating in a clinical trial

Why Participate in a Clinical Trial Study?

Your participation helps find answers and solutions so future generations that inherit FSHD have access to treatment in their lifetime. The quicker we are able to recruit individuals for research studies, the sooner we can find answers and develop treatments.

Study participation connects you with top FSHD researchers knowledgeable of new and upcoming studies, granting you firsthand insight to current developments. Also, as a current or recent study participant, we'll have basic information to allow us to match your qualifications for participation in other studies. It may even be possible to screen you at one of your current study visits, if allowed by the sponsor, for participation in a new study.

What is the Typical Timeframe of a Research Study?

Participation time varies from study to study. Some studies are a one-time visit or one-time survey. Other studies, usually clinical trials that involve study drugs, may last for a year or more and require multiple visits. Your local research site can provide you with the expected participant time commitment for each currently enrolling study.

What is Needed/Criteria for Participation?

Each study will have specific eligibility criteria. Each criterion ensures research volunteers can safely participate in the study procedures. Generally, most studies expect the following:

  • You have genetically confirmed FSHD. It is helpful to provide a copy of your test results to researchers that they can keep it on file. Some studies will genetically test you for FSHD before enrolling you in the study.
  • You are not wheelchair-dependent full-time. Many studies perform muscle testing and functional assessments that require some walking.
  • You do not have a major medical problem that potentially makes it unsafe for you to participate, such as cancer, major heart, kidney or breathing issues.
  • You are not pregnant or planning to become pregnant. The study procedures may pose risks to the fetus.

What to Expect at a Research Study Visit?

The process will vary between studies and institutions, but generally participants are expected to travel to the institution to participate onsite. Most studies require that participants remain anonymous, so you will usually be seen alone at your visit and not pooled with other participants. Some studies involve surveys that can be done at home, or blood draws that can be done at your doctor's office or local blood draw laboratory.
You can expect confidentiality of your information and your participation. All studies are approved under strict research guidelines explaining how data will remain anonymous and secured.
You will never be persuaded to enroll in a study that you are not comfortable with, and you always have the right to drop out of a study. Contacting an institution to learn more about a study does not obligate you to participate, and is the best way to get answers to all of your questions and learn more details.

How Do I Find Studies?

  1. Search "FSHD" at clinicaltrials.gov, choose a study, then navigate to the "Contacts and Locations" section to find the study site closest to you
  2. Join the National FSHD Registry at dystrophyregistry.org. You will complete surveys annually to update your information so you can receive information about studies for which you may be eligible.
  3. Visit the Volunteer for Research section of the fshsociety.org website


What if I am Not Eligible or Cannot Participate?

Being ineligible for one study does not mean you may not be eligible for another. Studies have specific criteria designed to make sure it is safe for you to participate. Your safety is the first and most important concern in any study. If you are currently unable to participate due to time constraints, travel, etc., then you can encourage others, such as family, to participate. You can also ask the research site to contact you about future studies.

As a general guideline, you should see a neuromuscular specialist or neurologist on a regular (semi-annual or annual) basis. They can help monitor how you are doing and how you are progressing. Regular visits to your practitioner is also a great way to stay current and informed of new studies and your possible eligibility, as well as newly approved treatments or guidelines for FSHD patients.

Have additional questions?

Contact:

Kiley Higgs, FSHD Project Manager
Ksims2@kumc.edu
913-945-9922

Leann Lewis, FSHD Study Coordinator
Leann_lewis@urmc.rochester.edu
585-275-7680

Last modified: Apr 22, 2019
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Clinical Trials
Contact Us

Kiley Higgs
Project Manager
913-945-9922
ksims2@kumc.edu

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