Basic research is necessary to achieve an understanding of the normal and pathological state, but can not, by itself, put new knowledge to useful applications. The bridge to application is created by the development of diagnostic tests, new drugs or treatment approaches that allow an intervention in patients. The bridge between basic research and new treatment approaches is difficult but necessary to build and the clinical trial is a core research methodology step in that journey. The clinical trial then becomes the medium through which the value of the new intervention is measured.

In order to take advantage of the research potential of the HMS-affiliated institutions, Massachusetts General Hospital and its partners in the DF/HCC have established a clinical trials support structure for coordinating clinical research activities, for supporting the design, review and approval, and performance of clinical trials and for evaluating patient outcomes as affected by application of research discoveries. The vision captures the belief that through patient-oriented research that relies significantly on ongoing discoveries in basic science, DF/HCC will continuously improve clinical treatment and generate new research ideas. Reaching our vision requires a strong and workable partnership between basic and clinical science. The essential components of the clinical organization of both Massachusetts General Hospital and DF/HCC are individual Disease Programs, which have cross-institutional members sharing a common research interest. Each Disease Program is responsible for fostering research collaboration among its participants, defining the research agenda for those malignancies under its review and generating a set of research protocols to carry out this agenda. This operating model for rests on implementation of the clinical care and research agenda of the Disease Programs at the Massachusetts General Hospital and other HMS-affiliated institutions. For this purpose, MGH utilizes a multimodality Disease Center approach for each of the most common malignancies, including breast, thoracic, gastrointestinal, and genitourinary cancers, as well as less common types of neoplasm. The multimodality clinics are served by teams of specialists, including but not limited to medical oncologists, radiation therapists, surgeons, and other allied health professionals. The Disease Programs and Disease Centers are fundamental to both the research and clinical care mission, of the MGH and DF/HCC. The guiding principles for these programs are:

1. multimodality participation in clinical care and research
2. a unified system of clinical trials in each disease category

All Disease Programs are served by the same system for clinical trials management and support. The decision to coordinate clinical research through the multimodality Disease Program committees was based on the belief that the optimal management of cancer patients requires the input and close cooperation of multi-disciplinary teams.

Clinical trial oversight at the Massachusetts General Hospital includes our close involvement with the comprehensive Protocol Review and Monitoring System (PRMS) of the DF/HCC. PMRS consists of the peer review process, involving Scientific Review Committees (SRC) and the Human Subjects Protection Committee ( IRB), the Quality Control Center (QCC), a Data Management Resource, and the Clinical Investigations Policy and Oversight Committee (CLINPOC), which has responsibility for setting policy and reviewing performance of the entire system.

Bruce Chabner, MD, the Associate Director for Clinical Science at DF/HCC, heads the Medical Coordinating Committee that oversees protocol development by the specific Disease Program committees. He also chairs the Adult SRC, which is composed of representatives from each of the Disease Program committees, and which conducts a formal review of each new adult Cancer Center protocol.

Jeffrey Clark, MD, a Cancer Center medical oncologist with extensive experience in clinical trials design and implementation, assumed the position of Director of the Clinical Trials Support Structure at DF/HCC in 1997. In this capacity, Dr. Clark is responsible for all aspects of the integrated clinical trials infrastructure operations, from protocol review through protocol performance.

Clinical Trials Support Structures

1. Single Point Contracting
2. Common Protocol Management System
3. Common Patient Registration System
4. Common Auditing System
5. Integrated Biostatistics
6. Integrated Research Pharmacy Support

As of 2004, there are approximately 300 open clinical trials at with a yearly patient accrual of close to 900 patients. Approximately one third of these trials are supported by the NCI (National Cancer Institute of NIH), one third by agreements with industry, and one third by institutional funding.

Faculty
Jeffrey Clark, MD
David P. Ryan, MD
Jeffrey G. Supko, PhD