By Yi Cai `11, thurj Staff

Collaborative efforts between the Harvard Medical School, Beth Israel Deaconess Medical Center (BIDMC), and Partners HealthCare founded the non-profit institution, the Harvard Clinical Research Institute (HCRI). In this joint venture headquartered near the Boston University campus, industry meets academia to advance clinical research in multiple areas, from medical device trials to quality of life assessments.

The Origins

HCRI was founded with much of the same collaborative zeal and academic focus that the institute continues to emphasize today. At the Harvard Medical School about a decade ago, Dr. Eugene Braunwald, Dr. Joseph Martin, Dr. Victor Dzau, and Dr. Ray Dolin shared the vision of a union between academia and industry to create a clinical research organization that would contribute to the field in a productive and responsible way. Their brainchild came to life with the launch of HCRI in 2000.

The institute also involved entities from BIDMC and Partners Healthcare. For instance, the then Cardiovascular Data Analysis Center (CDAC) at BIDMC became an important part of HCRI. Dr. Jeffrey Popma, a founder of CDAC, recalls the inspiration behind the beginning of the center. At the time, he says, “the databases to house the data were not very sophisticated.” So, CDAC was founded “to assist in the generation of reliable data and to facilitate an interface with industry.” In the mid-1990’s, CDAC carried out many clinical trials that would come to transform the field of coronary stenting. After the founding of HCRI in 2000, CDAC became a part of the institute formed to facilitate collaboration between BIDMC, Massachusetts General Hospital, and Brigham and Women’s Hospital.

The Mission of the Institute

Currently, HCRI continues to provide full-service clinical trials and is regarded as one of the premier institutions of its field. HCRI is affiliated with Harvard and consists of professionals involved with the institute at a formal or informal level. However, it also has characteristics that set it apart from other clinical research organizations. For one, Executive Director of Clinical Investigations Dr. Donald Cutlip says that what makes HCRI unique is the “availability of typical commercial services within a world-class academic environment.” That is, academic physicians and scientists are involved throughout each stage of a trial, and the institute is supervised by a Board of Directors composed of academic professionals. Furthermore, HCRI upholds a strict conflict of interest policy. As Dr. Cutlip notes, “this adds a level of independent oversight that is not seen in most commercial clinical research organizations or certainly when individual industry sponsors oversee their own trials.”

HCRI’s emphasis on academics does not go unnoticed. Dr. Cutlip accredits HCRI’s “academic reputation and ability to work with industry without the usual conflicts” as crucial in their winning a proposal for an important research project called Dual Anti-Platelet Therapy (DAPT). The project, which just started this past fall, aims to design and manage a large public health trial for the study of appropriate clot prevention therapy for patients who receive coronary stents (small tubes placed in coronary arteries that are blocked in order to treat coronary heart disease). This study was mandated by the Food and Drug Administration (FDA), is sponsored by four large stent manufacturers and four large drug companies, and is projected to involve over 20,000 patients. Indeed, “it is a high-profile study and the proposal was won during a very competitive process.”

Facing the Future

HCRI faces many challenges moving forward, especially in the current economic climate. Inevitably, innovation in the field has slowed as a result of clinical trials moving along longer timelines than in the years before. Consequently, the economic side of clinical research has become increasingly significant. Dr. Matthew Reynolds, Director of HCRI’s Economics and Quality of Life Research Center, says that it is now more important for “developers of new technologies, such as our sponsors, to demonstrate not only the clinical value, but also the economic value of their techniques.”

However, HCRI has been pleasantly surprised by their performance in the dire economic climate. “Last year, HCRI overcame economic challenges by sound business practices and careful economic planning,” says Spencer Goldsmith, President of HCRI. Dr. Reynolds also credits the federal stimulus package with creating many new opportunities for comparative effectiveness research. Currently, HCRI is undertaking two NIH-funded comparative effectiveness projects and in the process of designing more. Dr. Cutlip explains that some prospective studies plan to “compare non-surgical heart valve replacement with open heart surgery in patients who are at higher risk for open heart surgery. This is a very novel therapy that is in its infancy but could have major impact on future treatments.” Thus, despite economic challenges, HCRI still seems to be steadily making progress toward its original mission each day.

One new goal for the future of HCRI, according to Dr. Cutlip, is to “reach out as an academic leader to help improve clinical research methods, which includes development of industry models for adjudication of clinical events within clinical trials, an area in which we have become recognized as a leader.” HCRI has recently founded the Academic Research Consortium, a collaboration of other academic research organizations, industry, and the FDA that aims to standardize clinical trial designs and endpoint definitions for clinical trials of coronary

stents and heart valves. In its collaborations with the government, HCRI has had a powerful impact on the production of biomedical products and on their implementation. HCRI also hopes to play a role within Academic Research Consortium to help improve the conflict disclosure and management process. Dr. Cutlip says that clarification of these policies within Harvard institutions has been a major development, and extending such developments to the rest of the field is an important issue.

HCRI has clearly made great contributions to the field of clinical research, due in part to its academically-oriented mindset. As Dr. Popma reflects, “without the collaboration between academics and industry, I am not sure that the advances that have happened over the past decade could have been achieved.” As HCRI celebrates its decade anniversary, it has not only many accomplishments to commemorate, but also many more to expect.