Core Working Groups

Core Working Groups

Biostatistics and Study Design

Creates guidance and technical documents regarding study design and biostatistical issues; develops case studies; and allies with collaborators, NIH Collaboratory Trials investigators, and academic institutions to gather input into key methodological issues.

Electronic Health Records

Created the NIH Collaboratory Distributed Research Network to enable distributed remote analysis of research datasets across health systems and act as the key repository for the tools and infrastructure we create to leverage EHRs to support clinical research across multiple health systems.

Ethics and Regulatory

Develops policies and practices to provide a framework for the conduct of health systems research in an ethical manner and in compliance with federal and state regulations. Also, identifies areas of uncertainty and aids the NIH Pragmatic Trials Collaboratory and its network in resolving uncertainty through dialogue or empirical research when needed.

Health Care Systems Interactions

Engages those involved in healthcare delivery systems to participate in research, facilitate the design and conduct of research protocols attractive to practitioners, lower administrative barriers, and communicate results to all parties.

Health Equity

Develops guidance for pragmatic trials on how to integrate a health equity lens in PCTs, including considerations for enrollment, strategies for selecting outcomes, and tailored research methods that better suit the study population. Documents barriers to the integration of a health equity lens in pragmatic research. Develops strategies and tools to facilitate a health equity lens in pragmatic trials.

Implementation Science

Supports NIH Collaboratory Trials in achieving their implementation-related research aims. Promotes the uptake and sustainability of NIH Collaboratory Trial interventions that have proven effective in routine practice. Provides guidance on de-implementation of interventions when necessary. Produces guidance and best practices for conducting implementation research as part of ePCTs.

Patient-Centered Outcomes

Creates guidelines and defines best practices with respect to (1) selecting, compiling, and curating the most appropriate PRO measures (and stimulating the development of new instruments when new solutions are needed); (2) the creation efficient, high-quality PRO data collection systems compatible with EHRs and registries; and (3) conducting statistical analyses of PRO endpoints.