Drug Evaluation
Dana-Farber/Partners CancerCare, the collaboration of Dana-Farber/Brigham and Women’s Cancer Center and Massachusetts General Hospital Cancer Center, has created a fully integrated system for performing clinical trials and evaluating new drugs and diagnostic reagents. Currently, more than 2,200 patients a year are placed on therapeutic trials within Dana-Farber/Partners CancerCare. Protocols approved by Dana-Farber/Partners are activated in the three major institutions (Massachusetts General Hospital, Dana-Farber Cancer Institute, and Brigham and Women's Hospital). However, selected trials may also include Dana-Farber/Partners-affiliated institutions.

Integrated, Efficient Structure
Dana-Farber/Partners has created an integrated structure for contracting with industry, writing protocols and approving new trials, and auditing ongoing research. This consolidated infrastructure now activates 10 new cancer trials each month, half of which are supported by industry agreements. These include industry-initiated studies as well as trials initiated by Dana-Farber/Partners investigators with funding by the private sector.

An efficient system has been put in place to initiate new trials of a completed protocol and to provide integrated trials management for all Dana-Farber/Partners institutions.

Jeffery Clark, M.D., a leading medical oncologist who specializes in gastrointestinal cancer, supervises all aspects of the integrated clinical trials structure of Dana-Farber/Partners CancerCare, including the review and approval of new trials, data management, quality control, and auditing.

A Broad Range of Research Opportunities
This clinical trials system has strong ties to the basic science and translational research laboratories within the Dana-Farber/Partners institutions. These ties provide a broad range of opportunities for enhancing the understanding of new drugs, from mechanistic studies of drug action in human tissues and tumors and pharmacokinetic studies to novel imaging approaches and the assessment of drug action. Areas of particular strength and interest include angiogenesis, clinical genetics, vaccine development, and gene therapy.

A Large Clinical Population
Because of the large clinical population served by Dana-Farber/Partners, investigators are able to conduct all phases of new drug evaluation, including initial Phase I trials, Phase II single-agent studies, combination therapy trials, and even larger Phase III comparisons of a new drug with a standard regimen.

Dana-Farber/Partners currently has 350 active clinical trials. Of these, 25 percent are initiated by industry and 20 percent are initiated by Dana-Farber/Partners but sponsored by industry. The remaining 55 percent are grant or institution supported.

Core Resources
Dana-Farber/Partners provides biostatistical support for the development and analysis of collaborative research. In addition to providing assistance in the planning of new drug studies, the highly experienced biostatisticians from the three Dana-Farber/Partners institutions direct two cancer cooperative groups, the national clinical genetics network, and the Phase I cooperative agreement held by Dana-Farber/Partners members.

The Clinical Pharmacology Laboratory, under the direction of Jeffrey Supko, Ph.D., offers a full range of support services, including assay development, metabolite identification, pharmacokinetic analysis and modeling, and sample collection and processing for correlative studies. A staff of clinical research assistants trained in protocol research methods and sample collection serves both Dana-Farber/Partners patient-care sites. Technical capabilities include GC-MS, HPLC-MS, standard HPLC, and capillary electrophoresis. The laboratory follows strict GLP practices and is currently conducting pharmacokinetic studies for industry collaborators.

Dana-Farber/Partners also offers the opportunity to utilize the latest in imaging technology, including PET and MRI, to correlate metabolic and angiogenic parameters with pharmacokinetics and drug response. In addition, the laboratories of Dana-Farber/Partners collaborate with industry in studying drug action and effects in accessible tissues.

Integrated, Prompt Trials Review and Approval
Dana-Farber/Partners has a single, fully integrated process for the review, approval, activation, and performance of clinical trials, with common systems for patient registration, data-management, quality assurance, and auditing. Its core supports, such as biostatistics and the Clinical Pharmacology Laboratory, are also fully integrated. Review of new clinical research protocols begins in the Disease Programs or the Experimental Therapeutics Committee, where they are assessed for scientific validity and clinical importance. They are then promptly processed through a single, integrated Scientific Review Committee (SRC) and a single, integrated Institutional Review Board (IRB), each of which has representation from all three Dana-Farber/Partners institutions.

Strict Quality Control and Assurance
The institutions comprising Dana-Farber/Partners have well-earned reputations for conducting clinical trials of the highest quality. Dana-Farber/Partners continues that commitment to research excellence through continuous quality improvement and multiple, integrated systems and safeguards designed to ensure accuracy and maintain the highest standards.

A single Clinical Investigations Policy and Oversight Committee is responsible for Dana-Farber/Partners' quality assurance and improvement efforts, regulatory compliance, and data verification. This committee oversees a stringent internal, peer-reviewed auditing process as well as the Quality Assurance Office for Clinical Trials, which monitors patients' eligibility for specific trials and ensures accurate data management.

The goal of the auditing process, which is common across all Dana-Farber/Partners institutions, is to ensure high quality clinical research at all levels. Approximately 60 audits a year are performed, with priority given to new investigators and Phase I-II trials. Members of the Clinical Investigations Policy and Oversight Committee review all audit reports promptly after completion and take immediate action, if necessary, to correct any protocol deficiencies. The auditing process incorporates definitions of major and minor violations used by the National Cancer Institute and national cooperative groups, an audit grading system prompt final review by the Clinical Investigations Policy and Oversight Committee, responsive action, and timely follow-up.

To Initiate a Clinical Trial
For more information about clinical trials agreements with Dana-Farber/Partners Cancer Care, contact Mary Melloni at 617-632-4192 or mary_melloni@dfci.harvard.edu.