July 14, 2000

Partners HealthCare System, Harvard Medical School (HMS) and CareGroup have forged a comprehensive clinical research partnership to enhance the Harvard medical community's role as a world leader in clinical research. The Harvard Clinical Research Institute (HCRI) is in the final stages of the incorporation process. Among the key participating institutions are the MGH, HMS, BWH and Beth Israel Deaconess Medical Center (BIDMC).

"This new partnership will enhance our ability to contribute to what promises to be a very exciting era in biomedical research," says Samuel O. Thier, MD, Partners president and CEO. "The institute also is a model of how Harvard Medical School and its teaching hospitals can work together to support our key missions in a turbulent health care environment."

William F. Crowley Jr., MD, director of the MGH Clinical Research Program, says that the new institute will expand the research potential of the institutions involved. "Bringing the Harvard institutions together in this way can be a potent force in enabling researchers to conduct combined clinical trials across the participating hospitals."

The institute is designed to facilitate clinical research by faculty members and to provide better access to the faculty for research sponsors from the pharmaceutical and biotechnology industries. Harvard medical community researchers currently conduct more than $600 million in research each year, of which about $40 million represents industry-sponsored clinical trials.

HCRI aims to expand clinical trials across the Harvard system, maintaining the highest standard of scientific rigor and protection of patients' interests. By offering central management for all aspects of research – from efficient and ethical study design to expert data analysis – HCRI is designed to increase Harvard's share of industry-sponsored clinical research to at least $140 million over the next five years.

HCRI's capabilities will include investigational new drug applications, study design and statistical expertise, electronic data collection, data monitoring and validation, quality assurance, data analysis and report writing. The information technology system will create and maintain databases on current trials, investigator and sponsor interests and patient populations, along with a website for patients and the public. The test interpretation service will offer high-quality, centralized interpretations of tests. Sample management will include collection, processing, storage, distribution and archiving of DNA, blood and tissue samples.

The institute initially will include the MGH, BWH and BIDMC – the three Harvard-affiliated hospitals with the largest research infrastructure and the broadest patient base. Ultimately the institute is expected to offer its services to all HMS-affiliated clinical institutions.