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Green Park Collaborative

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overview

Promoting Better Decisions Using Real World Evidence

GPC will identify and convene a diverse group of real world evidence (RWE) users, experts, and stakeholders to develop best practices for using RWE studies to reliably inform decisions by health plans, formulary committees, and clinical guideline developers. This effort will build upon best practices for designers of observational studies already developed by ISPOR, the CER Collaborative, and others. Informed by the needs of a broad range of decision makers and evidence assessors, these best practices will foster transparency and consistency in the way RWE is used by decision makers. In turn, they will significantly increase the confidence of those generating RWE studies in the value of their investments, and help to ensure that decision makers receive the relevant and reliable evidence they need. 

participation

Participation and Sponsorship Opportunities 

There are many ways for qualified experts to get involved, as GPC will engage key stakeholders, experts, and sponsors throughout this initiative. Sponsors and participants may be invited to sit on or nominate members to the following groups: 1) Advisory Committee, which will provide overall guidance on the project approach; 2) Methods Workgroup, focused on drafting an initial alternative evidence framework for later group discussion; and 3) Dissemination Workgroup, focused on developing a plan for the dissemination and uptake of the new best practices. They will also be invited to attend a June 2016 workshop in Baltimore, Maryland.  For additional information, please contact Marty Johnson at 410.547.2687 or via email.

activities

Developing a New Evidentiary Framework

GPC will work with healthcare decision makers and evidence reviewers to develop a new evidentiary framework and best practices for using observational RWE.  The project team will:

  1. Conduct background research to identify relevant decision makers, evidence reviewers and other key stakeholders. This will include traditional health coverage and reimbursement decision makers who require RWE, as well as an emerging new class of potential RWE users operating in accountable care organizations and other risk-bearing entities employing alternative business models to those of traditional health plans.
  2. Consult with methods experts and a group of RWE decision makers to develop a draft framework and best practices.
  3. Convene an in-person multi-stakeholder workshop to deliberate on the draft framework and best practices developed and work towards consensus on a set of recommendations for standards on the use of RWE for relevant decision makers. 
  4. In continued consultation with experts and other stakeholders, prepare a final guidance document based on the meeting.

goals

Project Goals

  1. Create an alternative framework to the traditional evidence hierarchy to accommodate a new generation of high quality observational RWE studies that meet a high threshold of validity and can be given more weight in the decision-making process.
  2. Define best practices for users of RWE in tandem with the alternative framework, taking into account the types of decisions made, and the tradeoffs between various types of randomized and non-randomized studies, and also the tradeoffs between study rigor and relevance to decision-making.
  3. Produce guidance document for decision makers that will allow them to easily and reliably identify the high quality subset of RWE studies that fall within a range of acceptable rigor such that they can be weighted for consideration in the full context of decision making, or discarded from consideration. Also produce accompanying guidance and/or tools for researchers.