An EHDN endorsement is a statement to the HD community that a protocol is of high scientific and ethic quality. It is highly influential within the community and is used by potential participants and sites to guide them in decisions about whether or not to participate in a trial. The EHDN Executive Committee (EC) is responsible for the endorsement decision that is based on the protocol review and a discussion taking into account the recommendations from the independent EHDN Scientific Bioethical Advisory Committee (SBAC).
Clinical trials endorsed by the EHDN EC must meet four criteria:
- They should be based on a solid rationale
- There should be no safety concerns that would imply that participants in the clinical trial would be exposed to substantial (and unacceptable) risks
- The proposed clinical trial plan includes pre-clinical/clinical data and appears to be appropriate, comprehensive, operational and likely to yield conclusive, definite results.
- The demands of the proposed trial on the network, the clinicians active in running the trial, as well as the research participants and their families are acceptable in order to make good use of these resources.
To access EHDN services for feasibility assessment and operational support, a trial protocol must be endorsed. For additional information regarding endorsement please contact: Tim McLean.
To apply for endorsement, send an email and the final draft protocol to firstname.lastname@example.org. The endorsement procedure has been streamlined by providing a single contact person (Tim McLean) who will ensure that the internal review process is conducted. Applicants will be informed about the timelines, whether there are any questions for clarification and the EHDN EC endorsement decision.
For global trials, assessment and recommendations may be provided jointly with other networks, including the Huntington Study Group or the Chinese Huntington’s Disease Network.
For examples of EHDN-endorsed clinical studies, click here.
This committee has transitioned and is now the Enroll-HD Clinical Trial Committee.