CORE--CENTRALIZED PROTOCOL AND DATA MANAGEMENT UNIT

Yeshiva University, New York NY

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): The Clinical Protocol and Data Management Unit (CPDMU) is a shared AECCC resource that serves the clinical research community to assist in the conduct of translational and clinical trials with patients at AECCC. Specific functions include: overseeing all regulatory functions for protocol submission and management; providing high quality data management; interactions with NCI; maintaining the clinical database; serving as an educational resource for patients. The CPDMU has been reorganized and expanded: (I) new space was assigned on both campuses of the Motefiore Medical Center; (ii) Senior Data Manager, Alicia Destro, was recruited to oversee the functions of the CPDMU (iii) data management staff was reorganized and expanded; (iv) a Microsoft Access clinical database was created to track all clinical protocols, documents, patient demographics and patient outcomes, and now contains information about >300 patients and >600 protocols; (v) multidisciplinary meetings of nurses and data managers were instituted on a monthly basis. In addition to Ms. Destro, key members of the CPDMU include two Ph.D. level biostatisticians, who support the clinical efforts, and two research pharmacists, who are an important resource in the drug development, biologics and gene therapy programs. The current staff of 22 supports 180 active clinical trials with 1388 protocol patients in active treatment or follow-up. There has been growth of patient accruals onto clinical trials; 386 patient accruals are projected for year 2000 to therapeutic trials from both campuses. There have been 67 investigator-initiated clinical trials since January 1995. Accrual to investigator-initiated protocols has grown consistently since 1997, reaching 172 projected patients in 2000. Efforts to accrue minority populations have been highly successful, and now account for nearly two-thirds of accruals to clinical trial. Likewise, recruitment of women accounts of nearly 60% of all accruals, reflecting the institution?s commitment in part to the New York Gynecologic Oncology Group and the large program in breast oncology Further expansion of the CPDMU is planned as new faculty are recruited and new programs are implemented. Other planned improvements include the conversion of the clinical database to SQL/Sybase so that patients can be directly registered into the database and so that more users can have direct access to information about their trials. Furthermore, there are continued efforts to convert all retrieval and management into an electronic format; efforts are being made to implement this conversion to a paperless system with electronic transfer of data to CTEP and EGOG. The reorganization of the CPDMU will continue under the guidance of Ms. Destro, with recruitment of additional data managers and upgrading the skill levels of current staff. The Web site for the AECCC will be improved to provide more information about current protocols to physicians and the public.