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CLINICAL RESEARCH Harvard Launches Clinical Research InstituteHMS, Partners HealthCare, and CareGroup have forged a comprehensive clinical research partnership to expand clinical trials in academic health centers and enhance the Harvard medical community's role as a world leader in clinical research. In a ceremony on June 28, an agreement creating the Harvard Clinical Research Institute (HCRI) was signed.
Coalition builders: The architects of the new Harvard Clinical Research Initiative (HCRI) give a final review to the documents they signed to make the partnership a reality. From left, Samuel Thier; Joseph Martin; James Reinertsen; James Breitmeyer; and Raphael Dolin (standing). Photo by Steve Gilbert James B. Breitmeyer has been named chief executive officer of the new institute. He will manage the overall operations of the not-for-profit corporation and oversee the relationships among participating institutions. Breitmeyer comes to HCRI from Serono Laboratories, where he was senior vice president and chief medical officer. He will report to a board of directors composed of 12 members appointed equally by HMS, Partners, and CareGroup. Among the key participating institutions are HMS, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, and Massachusetts General Hospital. Serving Patients, Industry"The appointment of James Breitmeyer and creation of the Clinical Research Institute culminate two years of study, planning, and negotiation by many dedicated people in the Harvard medical community," said HMS dean Joseph B. Martin. "This unique partnership will take us into the 21st century positioned to provide efficient contracting to industry, trials with academic rigor, and a patient population large enough to find out quickly how effective a new therapy may be."The institute is designed to facilitate clinical research by faculty members in affiliated institutions and to provide better access to the faculty for research sponsors from the pharmaceutical and biotechnology industries. The Harvard medical community currently conducts more than $600 million in research each year, of which about $40 million represents industry-sponsored clinical trials. Dollar ValueHCRI aims to expand clinical trials in academic health centers, with 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 fast and simple patient accrual procedures to expert data analysis—HCRI is envisioned to raise Harvard's share of industry-sponsored clinical research to at least $140 million over the next five years."This new partnership will enhance our ability to contribute to what promises to be a very exciting era in biomedical research," said Samuel Thier, Partners president and CEO and professor of medicine and health care policy at HMS. "The institute is also 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." James L. Reinertsen, CEO at CareGroup and HMS professor of medicine at Beth Israel Deaconess Medical Center, adds that "we are very excited that Harvard's teaching hospitals are taking this important step to expand our clinical trials program. Clinical research is a key method for determining what works and what doesn't as we advance the science of medicine. We look forward to moving ahead in this vital endeavor." HCRI's mission is to provide users with a comprehensive range of clinical research services. One major component of the institute will be what Breitmeyer calls an academic research organization, designed to expedite all facets of performing clinical research studies at the Harvard hospitals and affiliates. HCRI will also facilitate the scholarly projects of HMS faculty. The institute will work to match research sponsors with investigators in both industry-initiated and investigator-initiated studies and to recruit and refer patients. It will be responsible for drafting research contracts, budgets, and submissions for study approval to institutional review boards and the U.S. Food and Drug Administration. "Our overall goals are to maximize scientific rigor, quality, efficiency, and simplicity in clinical research," Breitmeyer says. In the past, the fragmentation of the Harvard medical community has often made it difficult for industry research sponsors to tap its vast but uncoordinated resources. HCRI will change this by bringing the affiliated institutions together as a "virtual single site." Breitmeyer also notes, "Many Boston-area biotechnology companies currently feel they must leave this area to find academic collaborators and access to patients, when this should be the first place they look for support and collaboration." VitaThe institute's goals are clearly ambitious. But Breitmeyer's background should serve him well in steering HCRI into uncharted waters. He earned both MD and PhD (immunology and pathology) degrees at Washington University in St. Louis. He knows the Harvard medical community, having trained as a cancer researcher at Dana–Farber. At Serono, he built from scratch a clinical research program of 40 to 50 trials a year of recombinant protein products, ranging from Phase I safety trials to Phase IV post-marketing studies. And he has developed an interest and expertise in clinical trial methodology out of the necessity to create innovative research designs to study new classes of agents. Drugs developed under Breitmeyer's leadership at Serono include agents now on the market for growth hormone deficiency, infertility, multiple sclerosis, and AIDS wasting syndrome.HCRI's capabilities will include investigational new drug (IND) applications, study design and statistical expertise, electronic data collection, data monitoring and validation, quality assurance, data analysis, and report writing. The clinical materials management component will have three facets in addition to drug supply. 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, including radiology and imaging tests, electrocardiograms, and laboratory assays. Sample management will include collection, processing, storage, distribution, and archiving of DNA, blood, and tissue samples, with excess specimen material preserved to create a repository for use in future research. Educational programs will be another of HCRI's primary activities. These will encompass training for students, physicians, study coordinators, and others who work on clinical trials; continuing medical education; and scholarly research and publications, possibly including a textbook of clinical research. "In accord with the longstanding traditions of scientific excellence and public service upheld by Harvard Medical School and our renowned teaching hospitals, the Harvard Clinical Research Institute will not only perform the most rigorous and careful clinical trials, but will also provide the highest possible level of protection for the patients involved in our studies and operate under the highest ethical standards," says Raphael Dolin, HMS dean for clinical programs. The institute will initially include the three Harvard-affiliated hospitals (and their affiliates) with the largest research infrastructure and the widest patient base. But ultimately, it is expected to be offered to all HMS-affiliated clinical institutions. —Tom Reynolds |
