Resource Labs

Phase I Clinical Trials Program

Basic research is necessary to achieve an understanding of the normal and pathological state, but cannot, 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.

Overview

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 translating information learned in basic research laboratories, Massachusetts General Hospital (MGH) and its partners in the HMS-affiliated institutions of 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, we will continuously improve clinical treatment and generate new research ideas. Reaching our vision requires a strong and workable partnership between basic and clinical science.

To facilitate this, a translational research laboratory has been established for the processing and molecular evaluation of tissues as well as exploring potential biomarkers for patient selection and response. In addition, close collaborations have been developed with basic science laboratories to discuss how to bring new ideas into the clinic, radiology (including both imaging studies to evaluate the biological effects of agents as well as interventional radiology for biopsies as appropriate) and pathology (for molecular characterization of tumors). There is also close interaction with other disease programs to facilitate the transition of promising agents into trials in specific diseases. In order to take advantage of new molecules being developed by industry, a Pipelines in Oncology program (coordinated by Petra Loesch) has been developed within DF/HCC to encourage collaborations of both basic scientists and clinical investigators with industrial partners in designing and performing both preclinical and clinical studies utilizing these compounds.

MGH functions as a critical component of the Translational Pharmacology and Early Therapeutic Trials unit of the DF/HCC. Close collaboration between the HMS hospitals and oversight of individual trials is provided by ongoing weekly meetings about all patients on study and a monthly meeting reviewing both ongoing trials as well as concepts in development. Support for this unit includes a U-01 grant from the National Cancer Institute (PI: Dr. Kufe). At any one point in time, there are approximately 25 to 30 open therapeutic clinical trials within the Phase I program with a yearly patient accrual of between 40 and 50 patients to these studies. 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. Areas of particular interest currently being evaluated in clinical trials within this program based on research ongoing in basic laboratories at MGH include evaluation of inhibitors of growth factor receptors important in proliferation or survival of tumors (e.g. cMET and EGFR) and antiangiogenic agents, either alone or in combination with chemotherapeutic agents. In addition, the strong translational pharmacology unit headed by Dr. Jeff Supko provides ongoing research and support for careful pharmacological evaluation of agents alone and in combination.

Clinical Trials Support Structure

  • Single Point Contracting
  • Common Protocol Management System
  • Common Patient Registration System
  • Common Auditing System
  • Integrated Biostatistics
  • Integrated Research Pharmacy Support

As of 2008, there are approximately 300 open clinical trials at Masachusetts General Hospital, with a yearly patient accrual of close to 900 patients.