Core Outcome Sets

Promoting the Adoption of Core Outcome Sets in Clinical Research

The focus of this project is to define an approach to working with regulators and “post regulatory decision makers” (payers, formulary committees, HTA organizations, guideline developers, etc.) to promote broader uptake of core outcome sets (COS). 

Researchers are increasingly attentive to these decision makers when designing clinical studies. For this reason, securing their explicit recognition of specific COS as being influential in their decision making would create strong incentives for researchers to use those COS. This dynamic is widely recognized in the context of regulatory decision making, with clinical researchers already paying careful attention to clinical outcomes that are recognized by the FDA, EMA and other regulatory authorities. 

Regulators have defined mechanisms to review, approve, and communicate preferred outcomes through guidance documents, compendia, etc. Through this project, we hope to define a parallel set of mechanisms through which PRDMs could recognize health outcomes that best inform their decision making

Participation and Sponsorship Opportunities
This initiative will involve a broad, multi-stakeholder participant group. Currently, there are opportunities for participants, sponsors, and steering committee members. 

Steering Committee
The Steering Committee, comprised of a multi-stakeholder group of experts, is tasked with providing feedback and guidance on the aims, approach, output, and other key details of the GPC Core Outcomes Initiative. This committee will provide a sounding board to vet ideas related to the content, approach, and deliverables of the initiative to facilitate the greatest impact and relevance of the work to PRDM organizations.

Project sponsors will be included in all project activities as an equal partner, including membership on the project steering committee, participation in conference calls and in-person meetings, and involvement in producing written deliverables.

Additional project participants will be invited to weigh in on the development of the project, review draft recommendations, and attend the in-person multi-stakeholder meeting. Other activities may include participating in key informant interviews and providing input on dissemination materials.

Contact Jennifer Al Naber for further details. 

  • Spring 2017 – Participant and sponsor recruitment
  • Summer 2017 – Background research and key informant interviews; develop dissemination plan
  • Fall 2017 – In-person stakeholder meeting; finalize, disseminate, and implement recommendations via a white paper and various publications

The goal of this project is to identify mechanisms available to “post regulatory decision-makers” and evidence assessors that will promote broader uptake of core outcome sets in clinical and comparative effectiveness research.