GPC Releases Recommendations to Overcome Challenges in Core Outcome Set Adoption and Implementation in Clinical Trials

BALTIMORE, May 2, 2018 /PRNewswire-USNewswire/ -- The Center for Medical Technology Policy's (CMTP) Green Park Collaborative (GPC) has issued "A Multi-Pronged Strategy to Improve the Relevance, Usefulness, and Comparability of Outcomes in Clinical Research."  Developed through multi-stakeholder discussions, the paper outlines major challenges and considerations for development and utilization of core outcome sets (COS) in clinical research, and identifies potential solutions to these challenges.

The document is available to download online.

Often in clinical research, one or more treatments are studied for the same disease, yet the same outcomes are not measured and reported across studies.  When this happens, decision-makers lack a consistent basis to assess the comparative effectiveness and value of available treatment options. They may also lack the most relevant outcomes needed for these decisions, as determined by patients, clinicians, regulators, payers and other decision makers. Core outcome sets (COS), as defined by the COMET Initiative, are "an agreed-upon minimum set of outcomes that should be measured and reported in all clinical studies for related evaluations of a specific condition".  Adoption of COS will lead to better clarity and alignment around relevant outcomes used across multiple decision-making authorities.  While an increasing number of COS are being developed, their adoption by researchers has been inconsistent.  This project was designed to explore why uptake has been so inconsistent, to identify possible solutions to improve COS uptake in future research, and to better articulate the benefits of broad uptake.

The multi-stakeholder group did converge around several benefits of greater COS adoption in clinical research. These included:

1. better clarity and alignment around relevant outcomes used across multiple decision-making authorities, including regulators, payers, and health technology assessors,
2. greater certainty for manufacturers in deciding which outcomes to report,
3. greater ability for payers to make meaningful comparative assessments of evidence, and
4. greater assurance for patients and providers that the outcomes that are most important to them are informing critical policy decisions.

They identified several current hurdles to greater COS adoption, which included a lack of awareness of COS outside academic circles, and a lack of incentives or demand for use of COS from influential decision makers in the current health care environment.

The document describes several potential strategies to promote greater COS adoption, including a COS awareness campaign targeting multiple stakeholder communities, building consensus around methods for COS development, and specific steps that could be taken by influential decision makers, including payers, providers, research funders, journal editors and evidence assessors, to clearly signal to researchers their preferences for clinical research outcomes that will best inform decision-making.  In addition, it will be important to create platforms that allow greater collaboration across initiatives and programs that aim to harmonize outcomes used in clinical research, clinical care and quality measurement.

Greater adoption of COS can significantly improve decision making in various aspects of healthcare – there are hurdles to overcome, but this paper identifies pathways for stakeholders to drive broader adoption of core outcome sets.

GPC will continue working to promote awareness of core outcome sets, building consensus regarding COS development methods, and uniting stakeholders to collaborate in ways that will improve research outcomes for decision-making across healthcare.  GPC will soon release a set of core outcomes related to gene therapy for hemophilia, and launch an initiative to identify a core outcome set for nonalcoholic steatohepatitis (NASH). 

About the Green Park Collaborative
The Green Park Collaborative (GPC) is a major initiative of the Center for Medical Technology Policy, an independent 501(c)(3) non-profit organization dedicated to improving the quality, relevance, and efficiency of clinical research. GPC is a multi-stakeholder forum for developing condition- and technology-specific study design recommendations to guide the creation of evidence needed to inform both clinical and payment decisions.

SOURCE Center for Medical Technology Policy

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