CORE--CLINICAL RESEARCH SUPPORT COMPONENT

Dana-Farber Cancer Institute, Boston MA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The ultimate objective of the research projects in this program project application is to improve the therapeutic results for patients with myeloid malignancies including acute myeloid leukemia, myelodysplastic syndrome, and chronic myeloid leukemia. To achieve this objective, tumor cells and other relevant clinical samples from patients will be collected, catalogued, and distributed to the relevant projects for analysis of the expected therapeutic targets and other molecules that might be important in prognosis or pathophysiology. Secondly, a clinical infrastructure is required to carry out the clinical trials described in Project 5 and additional clinical studies that will emanate from the developmental approaches outlined in Projects 1, 8, 9 & 10. Clinical Research Core resources are required to carry out these functions which extend beyond direct patient care and the clinical laboratory. Without the clinical research support provided in the Core it would be impossible to coordinate the proper collection of multiple research specimens, the adherence to novel complex therapeutic schedules and timely follow-up of patients enrolled on research studies. Also critical to this success of the project is the collaboration of individuals in the Core with the staff from the Biostatistics Core who will provide a quality control system for specimen tracking, computerized data entry, quality of control data and will assist in the design and analysis of the clinical research protocols. The purpose of the Clinical Research Support Core is to provide the following services that will be utilized by all the clinical research studies: 1. To collect research specimens and coordinate patient follow-up at Dana- Farber Partners Cancer Center and collaborating institutions. 2. To act as liaison with outside physicians, hospitals, and biotechnology companies to coordinate the collection of research specimens and follow-up data. 3. To insure that study parameters are followed, ancillary specimens are collected on time and processed properly, confirm eligibility, and patient registration. 4. To insure the accuracy of submitted data from outside sources. 5. To provide data management for the collection of individual patient information.