The Huntington’s Disease Coalition for Patient Engagement (HD-COPE) is a globally recognized program organized by leading HD patient advocacy organizations who have united to give families affected by Huntington’s disease a direct voice in HD clinical research.
HD-COPE was launched in 2018, and its managing partners are the Huntington’s Disease Society of America and the Huntington’s Society of Canada.
The purpose of HD-COPE is to add quality to all aspects of the clinical trials process through worldwide representative input from persons living at-risk, or with HD, their family members, care partners, and youth. HD-COPE seeks to provide a coordinated and knowledgeable mechanism to contribute the global HD community experience to regulators, industry and researchers when needed. Patient-oriented input is essential to meet the needs of the patient community, speed up recruitment and decrease drop-out from clinical trials.
By expanding patient involvement beyond participation in trials as a subject, HD-COPE seeks to ensure that clinical research means research carried out ‘with’ or ‘by’ members of the community, rather than it being ‘to’ or ‘about’ them. Simply put, HD-COPE puts the HD community in the center of HD research efforts in a manner consistent with global PPI (patient participation initiative) or ‘patient-focused’ efforts.
To accomplish this aim, HD-COPE provides two-fold support to clinical partners:
1) Represented by the senior staff of each organization, the HD-COPE Managing Partners provide counsel to clinical research leaders on broad issues involving patient feedback, HD community needs and research recruitment.
2) HD-COPE manages a global HD-COPE Volunteer Team. Volunteers are HD community representatives with a passion for advocacy and an ability to contribute to discussions that will advance the development of HD therapeutics. Through a centralized recruitment and training program, HD-COPE ensures that volunteers have:
- Current or recent experience of HD as someone with HD/carer/person at-risk or who has tested negative.
- Knowledge and skills in understanding research projects and their role as a lay representative.
- Ability to listen to others and express their personal views in a constructive manner.
- Possess the confidence to work with a mixed group of patients, carers, health professionals, advocates and researchers.
All HD-COPE volunteers are able to attend meetings and communicate in English.
Clinical partners have incorporated the input of HD-COPE volunteers in a variety of ways. Examples include:
- Development of educational materials around a novel scientific approach or mechanism of action
- Gaining an understanding of what represents a meaningful decline or improvement in a particular HD symptom
- Appraising the willingness of individuals with HD to undergo a novel assessment or procedure
- Ensuring clarity of language within a novel patient- or caregiver-reported outcome
- Incorporating HD community perspectives into the design of clinical trials to maximize participant retention
- Review of clinical trial brochures and community outreach materials
At a time when clinical research is being challenged to include patient perspective, HD-COPE provides comprehensive support and access to the community to ensure that the experience of living with HD is an established part of the clinical research process, rather than an ad hoc activity.
For more information about HD-COPE and the role of HD community members in clinical research, please contact Dr. Arik Johnson at AJohnson@hdsa.org.
