the perinatal trials service
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Abs~a~s 679
Rewards; and (5) Peer Group. Physicians overestimated the number of patients they would enroll: mean intended annual accrual = 6.3, mean actual accrual = 1.1 (p = 0.001). Multiple regression analysis found five variables to be significantly correlated with intent to accrue (Multiple R = 0.80, p < 0.001): physician estimate of past accrual (r = 0.74); medical specialty (r = 0.30); pdncipal investigator (Pi) status (r = 0.23); Professional Activities (r = 0.23); and Peer Group (r = 0.20), while key predictors of actual accrual were (r = 0.49, p < 0.001): medical specialty (r = 0.37); physician intention in next 12 months (r = 0.35); PI status (r = 0.32); and Decision Making (r = 0.20). These findings support the predictive validity of the POP scales in addition to clinical setting and physician demographic vadables. The POP will help predict accrual of eligible patients and thus contdbute to successful completion of randomized clinical trials.
P31 THE PERINATAL TRIALS SERVICE
Adrian Grant and Diana Elbourne Radcliffe Infirmary Oxford, England
The Perinatal Trials Service was established in October 1990 to mount large simple randomized controlled trials to identify moderate effects of promising treatments for the most important problems in perinatal care.
Reliable identification frequently requires multicantar (often international) collaboration, either because the principal adverse outcome is uncommon, or because the relevant high-risk population is infrequent. Such collaboration is not best served by simple project funding: protocol development usually precedes such funding; a complement of skills is needed that cannot easily be justified for a single trial; these skills are needed episodically; delays in securing project grants can be fatally damaging; project funding is inflexible; and many aspects of coordination are common to all tdals. In contrast, consistent funding for the five-parson PTS core team--medical trialist, statistician, programmer, administrator, and secretaw---will allow the efficient coordi- nation of a program of padnatal tdals.
P32 EXPANDED COORDINATING CENTER ROLE: THE POSTMENOPAUSAL ESTROGEN/PROGESTIN
INTERVENTIONS (PEPI) TRIAL
H. Bradley Wells and Carol H. Wasllauskas Bowman Gray School of Medicine
Wake Forest University Winston-Salem, North Carolina
The complex Postmenopausal Estrogen/Progestin Interventions (PEPI) trial will examine the impact of five different treatment regimens on four primary coronary heart disease (CHD) risk factors, multiple secondary risk factors and bone density on participants at seven Clinical Centers. To enhance standardization and quality control, the Coordinating Center (CC) has arranged for a variety of central facilities, services and purchase of supplies and equipment including:
• Five Different Central Laboratories • A Central Pathology Center • A Bone Scan Quality Control Center • A Central Specimen Storage Facility • Hardware/Software for Distributed Data
Entry and Communications • Bone Densitometers & Service Contracts • Clinical Supplies • Express Shipping and Mailing • A Drug Distribution System
The organization and procedures required to make these central arrangements, including formation of expert referral committees, soliciting bids, evaluation criteria and site visits will be described.