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: Juliana Bronzova.
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 (Juliana Bronzova) 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.
To provide an opportunity for a consultation at early stages of protocol/program development the EHDN Executive Committee (EC) appointed the HD-CTTF in 2012 to act as an interface between the Network and its partners in the area of clinical trials. An important role of the task force is offering expert advice to partners in pharma, biotech, device companies and academic consortia developing clinical trial protocols for interventions in HD.
Another key focus of the HD-CTTF is the HD Clinical Trial Site Certification programme, which is highly relevant for centres interested in participating in clinical trials in HD. For more information about the programme read here.
The HD-CTTF operates as an independent global advisory expert group and availability of the global clinical platform of Enroll-HD gives the task force a truly global operational reach.