The HCS Collaboratory
Supported by the Common Fund at the National Institutes of Health (NIH), the Health Care Systems (HCS) Research Collaboratory is intended to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.
The NIH HCS Research Collaboratory also supports the design and rapid execution of several high-impact Pragmatic Clinical Trial Demonstration Projects that will address questions of major public health importance that engage health care delivery systems in research partnership.
NIH leadership for the Collaboratory is provided by Josephine Briggs, MD, director of the National Center for Complementary and Integrative Health (NCCIH); and Thomas Insel, MD, Director of the National Institute of Mental Health (NIMH).
The Collaboratory includes a Coordinating Center (CC) that provides national leadership and technical expertise in all aspects of research with healthcare systems. The Coordinating Center will make data, tools, and resources from these projects available to the greater research community to facilitate a broadened base of research partnerships with health care systems.
The Coordinating Center, based at the Duke Clinical Research Institute, is responsible for creating and maintaining the Collaboratory's public websites and collaboration tools. The CC also provides facilitative leadership, resources, and tools, and supports the fundamental requirement of coordination and productivity among expert Cores, working groups, committees, demonstration projects, and associated initiatives.
Core Working Groups
There are seven cores working groups in Collaboratory CC. These broad-spanning workspaces partner with all demonstration projects, and each core is focused on a specific topic, including electronic health records; phenotypes, data standards, and data quality; patient-reported outcomes; health care systems interactions; regulatory/ethics; biostatistics/study design; and stakeholder engagement. They work closely with demonstration projects to support their needs in specific domains.
The Steering Committee (SC) is the main governing body and decision-making committee for the Collaboratory and assumes overall responsibility for the consortium’s scientific direction, coordination, and oversight. The SC establishes priorities for the research and Skills Development Core activities to be funded.
NIH Common Fund
The Collaboratory is supported by a grant from the NIH Common Fund. Established in 2006, the Common Fund is designed to provide a strategic and nimble approach to address key roadblocks in biomedical research that impede basic scientific discovery and its translation into improved human health.
Common Fund programs are expected to transform the way a broad spectrum of health research is conducted. Initiatives that comprise Common Fund programs are intended to be catalytic in nature by providing limited-term investments in strategic areas to stimulate further research. Learn more about the Common Fund
The Research Collaboratory is designed in part to support the design and rapid execution of several Pragmatic Clinical Trial Demonstration Projects. These projects address questions of major public health importance and engage health care delivery systems in research partnerships. The data, tools, and resources produced by the Demonstration Projects will be made available to the greater research community to facilitate a broadened base of partnerships with health care systems.
NIH FDA IOM AHRQ CDC
AAMC ONC CTTI CDISC HL7
Coordinating Center Members
(listed below) work with the NIH to produce, document, and disseminate standards, and to create durable infrastructure that facilitates multicenter studies and reuse of data.
DUKE CLINICAL RESEARCH INSTITUTE
As the world’s largest academic clinical research organization, the Duke Clinical Research Institute (DCRI) combines the clinical expertise and academic leadership of a premier teaching hospital with the full-service operational capabilities of a major contract research organization. With more than 990 faculty and staff members, the DCRI is capable of conducting any clinical research project, from the smallest pilot study to truly global megatrials, as well as medical device trials to outcomes and quality of life analyses. Our experience stretches from phase I to phase IV and beyond, encompassing post approval analyses and health economics.
CENTER FOR MEDICAL TECHNOLOGY POLICY
The Center for Medical Technology Policy (CMTP) was established as an independent non-profit 501(c)(3) organization in January 2008 in order to improve 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 was established to provide a forum in which these decision-makers could play a meaningful and sustained role in all aspects of health care research, in hopes of generating better information about the comparative benefits, risks, and costs of health interventions.
Principal Investigator: Sean Tunis, MD, MSc
HARVARD PILGRIM HEALTH CARE INSTITUTE
The Harvard Pilgrim Health Care Institute’s Department of Population Medicine is a unique collaboration between Harvard Pilgrim and Harvard Medical School. Created in 1993, it’s the only appointing medical school department in the United States based in a health plan. Its staff includes leading physicians, researchers, clinicians and public health professionals. Institute staff work every day on critical research to help answer these questions. For example, the Institute is one of the lead organizations participating in the Centers for Disease Control (CDC) Prevention Epicenter Program, a nationwide effort to develop and test innovative approaches to reducing infections in health care settings.
Principal Investigator: Richard Platt, MD, MSc
GROUP HEALTH RESEARCH INSTITUTE
Based in Seattle, Group Health Research Institute is the non-proprietary, public-domain research arm of Group Health Cooperative, a nonprofit health system serving more than 600,000 members in Washington and northern Idaho. Our mission is to improve health and health care for everyone through leading-edge research, innovation, and dissemination. We envision a future where, through public-domain research and evaluation, we influence health care and policy to benefit all, and we advance Group Health's capabilities as a learning health care system. We are committed to developing the health science leaders of today and tomorrow, and to becoming the preferred health research partners for local, national, and international collaborations.
Principal Investigator: Eric Larson, MD, MPH, MACP
JOHNS HOPKINS BERMAN INSTITUTE OF BIOETHICS
The mission of the Johns Hopkins Berman Institute of Bioethics is to conduct advanced scholarship on the ethics of clinical practice, biomedical science, and public health, both locally and globally, and to engage students, trainees, the public, and policy-makers in serious discourse about these issues. We are committed to the following: (1) conducting cutting-edge, multidisciplinary research; (2) training the next generation of leaders in bioethics; (3) helping to prepare students and trainees for the ethical challenges of professional and civic life; (4) informing the public about bioethical issues; and (5) contributing to more ethical public policies and practices.
Principal Investigator: Jeremy Sugarman, MD, MPH, MA