430 Abstracts

P09 DATABASE MANAGEMENT OF NATIONAL CANCER

INSTITUTE-SPONSORED CANCER TREATMENT TRIALS

Pamela H. Phillips, Donald A. Vena, Christine L. Carter, Bruce D. Cheson

The EMMES Corporation Potomac, Maryland

Clinical trials typically generate an enormous amount of information on eligibility, patient characteristics, treatment response, clinical course, and survival from disease. The data that emanate from these studies are unique research resources and various large databases (e.g., the Physician Data Query) are available to track trial activity and results. We report here on a new database management system that contains information on all Phase II and Phase III cancer treatment trials, funded and sponsored by the National Cancer Institute (NCI), Cancer Therapy Evaluation Program (CTEP), and conducted by Cooperative Groups. In 1991, more than 22,000 patients were entered onto 429 Cooperative Group Phase II and Phase III therapeutic studies. The Clinical Investigations Branch (CIB) of CTEP has major responsibility to administer the cooperative agreement awards that support the Groups, to coordinate their activities, to convene strategy meetings, and to assist in idenlLCying the most important research questions regarding cancer therapy. The HYPOTHESES Database was designed and developed specifically to permit management of ongoing and planning of future trials. This database, in conjunction with the ACCRUAL database, reflects data regarding the research bases for and status of all currently active and closed CTEP-sponsored Cooperative Group and Intergroup trials. Each CTEP-sponsored Cooperative Group and Intergroup trials. Each CTEP-approved protocol is coded by CIB investigators for over 30 parameters including protocol identifiers, disease and hypotheses being studied, drugs, routes, modality, lab correlates, statistical design, phase, staging, quality of life component, etc. The ACCRUAL database, updated quarterly from information provided directly from the Groups, contains cumulative patient accrual, projected accrual, rates, etc. Both the HYPOTHESES and ACCRUAL databases are valuable tools for monitoring the status of clinical trials funded by the NCI across the country.

Pl0 A COMPUTERIZED NETWORK SYSTEM FOR THE MANAGEMENT

OF A LARGE SCALE MULTICENTRE CLINICAL TRIAL: THE GISSI-3 TRIAL

Eugenio Santoro, Maria Grazia Franzosi, and Enrico Nicolis

Marie Negri Institute Milano, Italy

The Coordinating Center (CC) of the Gruppo Italiano per 1o Studio della Soprawivenza nell'lnfarto Miocardico Acute (GISSI) used new telecommunication technologies to develop a computerized network system for the data management of the GISSI-3 study, a large-scale clinical trial which compares the efficacy of nitrate, ACE inhibitors, and their combination in reducing mortality and let~ ventricular damage in patients with Acute Myocardial Infarction (AMI).

Through a Personal Computer (PC), a communication program, a modem and a telephone line, the investigator in each participating centre can be connected with a micro-computer at the CC, and choose: a) to recruit and randomize a new patient in the study; b) to require a specific report about the advancement of the trial. In the first case, after he answered satisfactorily a set of predefmed questions, the system automatically checks eligibility criteria and assigns a random treatment and an identification code to the patient. In the second case, he can choose from a list of standard reports: the execution of the relative query on CC central da_~base, the generation, the formatting and the transfer of the selected report to the PC are executed automatically on line.

Main advantages of this system are: a) reduction of mistakes on data; b) better quality d at~; c) flexibility of the architecture; d) useful savings of human and economic resources; e) use of a dynamic and well balanced algorithm; f) real time updating of participating centres about trial advancement; g) possible use of electronic mail.

The system is in use since the start of the GISSI-3 study; in this period about 15,000 patients (out the final 20,000) were enrolled by 200 Coronary Care Units (CCU) distributed throughout Italy; CCU's directly connected with CC are 100.