CORE--CLINICAL RESEARCH

Northwestern University, Evanston IL

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The Clinical Research Office (CRO) of the Robert H. Lurie Comprehensive Cancer Center participates at all levels in the activation and conduct of clinical cancer research conducted through all of the affiliate network institutions. This includes protocol development, scientific and procedural review of new protocols, initial and periodic reviews submitted to the institutional review board, data coordination and collection, assuring quality with outside sponsors or internal reviewers as applicable, handling of biologic specimen acquisition for clinical/laboratory correlates, and coordinating supervision of appropriate trials by statisticians and the data monitoring subcommittee. Thirty investigators have utilized this facility during the most recent year (7/1/99-6/30/00), including fourteen with external funding. These investigators came from 11 departments within Northwestern University. Since 1995, the number of studies open to accrual during each 1 year period ranged from 364 to 390. During this time the number of studies which were still active requiring follow-up information during each period ranged from 539 to 816 (most recent). A total of 2284 patients were accrued to clinical trials from 7/1/99-6/30/00, including 1505 patients (66%) enrolled at the main institution (Northwestern Memorial Hospital), and 779 (34%) at network institutions. There were 737 patients enrolled to therapeutic protocols, 726 to cancer control/quality of life protocols, 608 to correlative studies, 206 to prevention trials, and 7 to ancillary studies. Importantly, 1640 of the 2284 (72%) total patients, and 275 of the 737 patients on therapeutic trials (37%), were enrolled on investigator initiated clinical trials with internal or external funding. During this grant cycle, five initiatives were undertaken with regards to the CRO with institutional support. These include: 1) centralization of the staff into a single location, 2) incorporation of hematology-oncology, radiation-oncology, gynecologic-oncology, neuro-oncology, and surgical-oncology administrative and select data collection staff into the CRO, 3)establishment of a scientific review process and implementation of the authority of the data monitoring subcommittee to regulate phase I through phase III trials, 4)establishment of routine internal quality assurance audits for institutional trials, and 5)creation of an Internet based paperless protocol management system which tracks all administrative functions of the office real-time and provides flexible clinical procedure scheduling to adhere to protocol directed procedures, but also includes personnel time management to comply with federal guidelines. Future developments for the CRO will include expansion of the Internet-based protocol management system to capture adverse events and track subsequent event resolution and track agency reporting as well as data acquisition and review, and further integration of data collection by all investigators performing cancer related research into the CRO.