Healthcare System Research Collaboratory-Coordinating Center – Rethinking Clinical Trials


by Asba Tasneem

The Collaboratory Coordinating Center (CC), intended to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research, is working towards its ultimate goal of ensuring physicians and patients are able to make decisions based on the best available clinical evidence. Collaboratory CC has been working with demonstration projects to create a durable infrastructure that facilitates multicenter studies and reuse of data, creating best practices, tools, and knowledge that will ultimately impact policy and practice.

The Collaboratory website features a Knowledge Repository (KR), an expertly curated body of resources and publications selected and/or produced by Collaboratory stakeholders. The KR will be complemented by Re-thinking Clinical Trials, a “living” textbook of pragmatic clinical trials that combines the authoritative qualities of a trusted publication with the flexibility of a controlled “Wiki” environment that allows content to be constantly refined by authorized individuals. To accelerate the conduct of EHR-based PCTs, the KR will promote harmonization and standardization of data elements that are used to describe a particular study population.

This effort is led by Robert Califf, MD. Collaborating members of this project team include principal investigators from several therapeutic areas and staff members from DCRI-CRI, DCTI-IT, DCRI-Communications, and CTTI.



by Swati Chakraborty

Duke is participating in a study planning phase funded by an NIH Phased Innovation Award for the NIH Common Fund Effort for the Health Care System Research Collaboratory. The study, Night-time Dosing of Anti-hypertensive Medications: A Pragmatic Clinical Trial, will compare the likelihood of major cardiovascular (CV) events between the intervention group taking night-time doses of one or more anti-hypertensive medications and control group taking morning doses of all ant-ihypertensive medications The study’s planning phase to design the randomized open-label pragmatic trial is a UH2 demonstration project.

The primary holder of the UH2 is the University of Iowa, under the direction of the Principal Investigator, Dr. Gary Rosenthal. The Duke team includes Eric Eisenstein, DBD, Bimal Shah, PhD, Swati Chakraborty, and Linda Shaw. The team is assisting in study design, workflow planning, protocol development, and cohort identification. The Duke Databank for Cardiovascular Disease (DDCD) is being used to estimate outcome event rates; the Decision Support Repository (DSR) is the primary source of

Grand Rounds on the study were presented on August 2, 2013. To view the Grand Rounds, go to: