CMTP Issues Recommendations for Late Phase Drug Studies in Type 2 Diabetes

July 2, 2014

CMTP has issued an Effectiveness Guidance Document (EGD) for Recommendations for Late Phase Drug Studies in Type 2 Diabetes. The EGD provides guidance for improving the design, conduct, and reporting of late phase (approval and post-approval) drug studies for patients with type 2 diabetes.

The EGD includes specific recommendations for the design of prospective clinical studies that reflect the evidence expectations of payers, informed by the perspectives of patients, clinicians, and other decision makers. The recommendations are made in four major areas:  population, outcomes, methods, and reporting for patient stakeholders.  The EGD is available online here.

CMTP’s Green Park Collaborative (GPC), a multi-stakeholder forum that develops condition and technology-specific study design recommendations to guide the generation of evidence needed to inform both clinical and payment decisions in the United States, developed this EGD.  This marks the first EGD published by GPC’s Endocrine-Metabolic Diseases Consortium, which is led by C. Daniel, Mullins, PhD, a Professor at the University of Maryland School of Pharmacy.

The recommendations were developed through an extensive consultative process involving several in-person stakeholder meetings, key informant interviews, and input from a technical working group (TWG).  Chaired by Nisa Maruthur, MD, MHS of The Johns Hopkins University, the TWG was comprised of patient representatives, researchers, payers, and clinicians who were recruited based on their background and expertise in diabetes research and care.

Support was provided by Aetna Foundation, Blue Cross Blue Shield Association, Covidien, Eli Lilly and Company, Genentech, Inc., GlaxoSmithKline, Kaiser Permanente National Community Benefit Fund at the East Bay Community Foundation, Merck & Co., Inc., Medtronic, Inc., Novartis Corporation, Sanofi US, and United Health Foundation.

About CMTP
CMTP is an independent, non-profit 501(c)(3) organization that aims to make health care more effective and affordable by improving the quality, relevance, and efficiency of health care research. We focus on the design and implementation of comparative effectiveness research to produce information that helps patients, clinicians, and payers make informed treatment and policy decisions. CMTP provides a trusted forum in which a broad range of stakeholders can collaborate to identify important research questions, design appropriate studies, and develop innovative partnerships to implement these studies.

Julie Simmons
401-547-2687 ext. 116