Abstracts 4 3 1

PI1 SYSTEM FOR MONITORING TIMING OF

DATA REVIEW AND ENTRY

Benny Zee, Lam Pho and Bey Koski Queen's University

Kingston, Ontario, Canada

Over the last few years, NCIC-CTG has been developing a variety of ways to monitor centre performance with respect to timeliness and completeness of data obtained from participating centres. Implementation of these monitoring procedures has improved results of compliance of forms submission. Another important aspect of quality assurance, which may sometimes be overlooked, is internal data quality control. Accuracy and completeness of data are usually the main focus for internal quality control without consideration of the timeliness of the process within a cooperative group setting. Although standard procedures for data processing at each level exist, it is not easy to perform formal analyses to ensure that procedures had been followed.

In order to qualify and assess the amount of time spent for various data management tasks, an oracle database management system was developed to capture the dates of a number of critical events during the data entry/verification processes. The design of the database and the actual implementation of this system will be discussed. The system consists of d~t_e of randomization, visit dates, date of form arrival, logged date, dates when form was reviewed by a study coordinator at various stages, data entry and modification dates, date when form was reviewed by a physician coordinator, and date of last update. The information obtained by this system will not only be useful for monitoring, it will also provide other information regarding trial planning and allocation of workload from an administrative point of view. Most of the dates will be generated automatically by the system and require relatively little extra effort. The amount of computing and personnel resources needed to implement this system will be discussed.

P12 PATIENT ACCRUAL: PAST EXPERIENCE, FUTURE OPTIONS

Linda Ward and Paul Wainwright Birmingham University

Birmingham, United Kingdom

Much attention is currently being given in the UK to improving recruitment to prospective, randomized cancer trials. The extra administrative burden placed on clinicians is quoted as being one of the major problems. It is suggested that trials centres and funding bodies could combine resources to provide general (community) hospitals with local data managers (DM) to support trials of national importance. However, both the logistics and potential extra costs appear daunting.

The CRC trials unit (CRCTU) in Birmingham has begun to evaluate the feasibility of establishing and coordinating a network of remote DM's based in participating hospitals. The CRCTU was established in 1983 to support and develop PlII trials in W. Midlands - the largest Health Region in the UK serving a population of 5.2 million. Since the early 1970s clinicians in the Region have been active participants in large randomized trials. Initially serving three collaborative groups in Breast, Stomach and Gynae cancer, our portfolio rapidly expanded to manage trials in other sites, notably Lung, Lymphoma, Prostate and Bladder. The majority of active studies attract participation throughout the UK.

An initial overview of accrual has been performed in 7828 patients randomized into 33 Pill protocols between 1976-92. In that lime 540 individual clinicians from 122 hospitals have entered patients. Participation by disease site shows that 68 hospitals entered took part in protocols for a single disease site, while 30 hospitals participated in two-three different types and 24 in four or more.

Looking at the geographical distribution showed that a quarter (23 %) of patients were entered by 84 hospitals outside the Region, with wider collaboration being essential to many studies. Interestingly, despite the high number of referring centres, nearly half (49%) of all patients were entered by ten hospitals within the City of Birmingham itself, with another 20% coming from 16 hospitals in easy commuting distance of the CRCTU office. The remaining 8 % came from 11 more distant Regional hospitals. If this overall picture is confirmed in current protocols, the CRCTU could consider providing travelling DMs in order to give increased support to the most active hospitals in the Region.