Abstracts 629

A29 THE CHANGING ROLE OF A PROJECT MANAGER DURING A MULTICENTER CLINICAL TRIAL

Susan E. Margltlc Bowman Gray School of Medicine

Winston-Salem, North Carolina

The project manager of a multicenter clinical trial is charged with organizing and coordinating all trial- related operations and acting as liaison between the trial headquarters and the clinic/laboratory sites. Although these responsibilities remain throughout the duration of a study, the nature and emphasis of the project manager's specific activities vary greatly as a function of the study's stages: planning, initiation of clinic operations, recruitment, follow-up, close-out and analysis. The NHLBI-sponsored Asymptomatic Carotid Artery Plaque Study (ACAPS) serves as a good example of how the role of the project manager changes as a trial progresses. Initial efforts during the planning phase (for example, protocol development, securing IND approval from the FDA, training clinic personnel) eventually evolve into very different activities during the next phase, the beginning of clinic operations (devising clinic procedures/documents dealing with investigational drug accountability and adverse reaction reporting, performing site visits to facilitate recruitment efforts, etc.). This presentation will describe the changing role of the project manager during a multicenter clinical trial. Principal Investigators and project managers embarking on new trials could find this information useful in anticipating the qualitative and quantitative changes in job responsibility that occur over the conduct of a trial.

A30 INTER-DATA CENTER AND INTER-GROUP COLLABORATION: THE EORTC EXPERIENCE

Denis Thomas EORTC Data Center Brussels, Belgium

Since many years, trials of different types and importance, mostly phase III studies, have been conducted by the EORTC in collaboration with non-EORTC groups and data centers (WHO, SWOG, MRC, UKCCSG, CSG, SAKK, SLOP, etc.).

In each trial, except for the most recent, a large number of different variables have been collected for each patient (22 to 151 variables recorded only once, and 30 to 126 repeatedly). In most of these trials a very detailed agreement had to be reached before activating the study. Design of forms, reporting clinical data, and modalities for data exchange (on paper or tape) required long discussions and thereafter a heavy administrative workload. Some of these forms were entered in two different computer systems at the same time, sometimes in duplicate. Patient selection criteria, and quality control of protocol adherence, response etc. were strict. These trials (both closed and still open to patient entry) accrued from 6 + to 607 + patients, and do not necessarily reflect the real accrual capabilities of the different cooperative groups.

This experience is confronted with new challenges, i.e., the need for very large trials, achievable only with the largest collaboration of different groups of physicians, and sometimes conducted where clinical trials are not yet common.

A more simple agreement on a limited number of end-points (including their definition and how to record them), data collection and exchange, is mandatory in order to attract more participants and to benefit from a true collaborative effort. This new policy is now followed at the EORTC and illustrated with some examples.

A31 DATA MANAGEMENT, DESIGN AND IMPLEMENTATION FOR THE GLOBAL UTILIZATION OF

STREPTOKINASE AND t-PA FOR OCCLUDED CORONARY ARTERIES STUDY

Lawrence H. Muhlbaler, Lynn H. Woodllef, William E. Moss, Kerry L. Lee, David H.Chrlstlaneen, and Robert M. Callff

Duke University Medical Center Durham, North Carolina

The Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries study (GUSTO) is a world-wide randomized controlled clinical tdal of three thrombolytic therapies; t-PA, streptokinase, and the combination of the two drugs. GUSTO is planned to enroll 33,000 acute myocardial infarction patients in 18 months beginning in January 1991.

GUSTO's data management (DM) system is designed in four relational modules: site description, phar- macy, randomization, and case reporting, each of which interacts with the others through shared tables and relations.