Using the DuchenneConnect Registry to Recruit for Clinical Trials

A key goal of the DuchenneConnect registry is to assist clinicians, pharmaceutical companies and researchers in developing new clinical trials and studies for Duchenne/Becker muscular dystrophy. By ascertaining subsets of participants, the DuchenneConnect Coordinator can identify target populations with the characteristics needed for recruitment of specific studies.

DuchenneConnect is deeply committed to issues of privacy and identity, and will continue to take every available measure to ensure the security of registrant personal information.

The DuchenneConnect Coordinator is available to discuss recruitment of a selected subpopulation. Requests to identify geographical regions for potential study site feasibility planning may also be discussed with the DuchenneConnect Coordinator.

Once a target subpopulation has been selected, study investigators/sponsors will be asked to submit the following study recruitment materials to DuchenneConnect for review:

  • DuchenneConnect Recruitment Submission Form
  • Study approval documentation consisting of one of the following:
  • A copy of the letter of IRB (Institutional Review Board) approval or appropriate human subjects/ethics committee approval (if outside the United States)
  • A copy of the IRB- or human subjects/ethics committee-approved (stamped) cover page of the Informed Consent Form, with contact information for participants A copy of the recruitment advertisement/notice (with contact information for participants) submitted and approved by the IRB (if available).

DuchenneConnect staff are available to review drafts of recruitment notice/advertisement in advance of IRB approval to provide the perspective of the patient community (See Review of Draft Recruitment Notices/Advertisements). Only studies approved by an IRB or human ethics committee will be sent to members of the subpopulation identified in the targeted search.

Once DuchenneConnect receives these materials, an internal review will be conducted. DuchenneConnect accepts studies that have been posted on www.clinicaltrials.gov, and those approved by an Institutional Review Board (or appropriate human subjects/ethics committee, if outside the United States). DuchenneConnect will consider recruitment requests for clinical trials outside the United States on a case-by-case basis. DuchenneConnect review is provided within 1-2 weeks, unless requested materials are not submitted in full.

Upon acceptance, study investigators/sponsors will be contacted by the DuchenneConnect Coordinator to establish dates for participant notification. Study investigators/sponsors should be aware that any communication to participants or information on www.duchenneconnect.org would include language to the effect that DuchenneConnect does not endorse specific studies, but provides recruitment advertisement/notices as a service to the community.  Participants are encouraged to discuss all study opportunities with their medical care providers.

Download Clinical Trial/Research Study Form