New “Collaboratory” aims to produce high-quality data for improved healthcare decision-making

The DCRI has been awarded a $9 million grant from the National Institutes of Health (NIH) to serve as the Coordinating Center for the NIH’s Health Care Systems Research Collaboratory.

The Collaboratory Coordinating Center, a joint venture of the DCRI, the Harvard Pilgrim Health Care Institute, the Group Health Research Institute (GHRI), Johns Hopkins University, and the Center for Medical Technology Policy (CMTP), 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 physicians and patients are able to make decisions based on the best available clinical evidence.

The Collaboratory’s principal investigator is Robert Califf, MD (pictured), director of the Duke Translational Medicine Institute. Eric Larson, MD, MPH, of GHRI; Richard Platt, MD, MS, of Harvard Pilgrim Health Care Institute and Harvard Medical School; Jeremy Sugarman, MD, MPH, MA, of Johns Hopkins; and Sean Tunis, MD, MSc, of CMTP, will serve as principal investigators for their respective organizations. Drs. Larson and Platt are leaders in the HMO Research Network. The Network is a consortium of 19 health care delivery organizations, many of which will take part in the Collaboratory’s projects.

Recent research suggests that the scientific evidence doctors and patients need to make sound medical decisions is often unavailable, Dr. Califf said. Many of the clinical trials currently being conducted also lack sufficient power and are not designed to reliably inform medical decisions. “The goal of the Collaboratory is to involve clinicians and patients in the design and interpretation of trials, provide the education needed to enhance the value of their participation, and use the data collected during healthcare delivery as the core data source for the full spectrum of clinical research, from registries to observational studies and pragmatic randomized controlled trials,” he said.

The Collaboratory was conceived to take advantage of recent developments in the fields of healthcare delivery systems and information technology. These include the evolution of health information technology, including widespread uptake and use of electronic health records, disease registries, and patient-reported outcomes; a major consolidation of medical practice into integrated health systems that allow better organizational and administrative support of clinical care and research; and the accumulation of experience that allows clinicians to successfully embed research in clinical systems.

“The Collaboratory is the embodiment of the vision first expressed by Eugene Stead, Duke’s first chairman of Medicine,” said Eric Peterson, MD, MPH, director of the DCRI. “Dr. Stead believed that computer technology would someday be used to collect and analyze data from routine clinical care so that we might gain insights into how to improve patient care.”

“This partnership among investigators at other institutions to work toward a common goal perfectly illustrates the idea behind the Collaboratory,” Dr. Califf said. “That is, bringing together the valuable insights and experience of others to conduct research in a collaborative environment, increasing efficiency, and providing benefit to our patients.”

The goals of the Collaboratory complement those of a new report released today by the President’s Council of Advisors on Science and Technology (PCAST), an independent panel of experts that advises the White House. Among the findings of that report—Propelling Innovation in Drug Discovery, Development, and Evaluation—are that innovations in the conduct of clinical trials could help accelerate the safe development  of new therapeutic compounds and reduce the high costs of conducting clinical research. Dr. Califf and Dr. Tunis were among the outside experts who helped inform PCAST’s work on the report, which makes a number of specific recommendations aimed at industry, academia, and federal agencies.