280 Abstracts

P-07 INDUSTRY INVOLVEMENT IN COOPERATIVE GROUP TRIALS:

EFFECTS ON DATA MANAGEMENT

Nancy Paul Chmcal Trials Group

Nattonal Cancer Institute of Canada Kingston, Canada

The CTG coordinates large mult~center chn~cal tnals (CTs) ~n cancer therapy nationally and ~nternat~onally In recent years both the proportion of CTG CTs sponsored by pharmaceutical compames (PCs) and the ~ntens~ty of PC ~nvolvement has ~ncreased markedly For each CT, the CTG and the PC negotiate case report design and data flow, on-s~te monitoring by the PC may or may not be done The CTG d~stnbuted a survey to all 130 data managers (DMs) ~n participating centers w~thm Canada to (1) assess the ~mpact of PC ~nvolvement in CTs on data management (DMT) generally and CTG DMT specifically, and (2) sohc~t recommendations for the eventual formulation of administrative and procedural guidelines for CTG-PC collaboration Surveys completed numbered 89 (68%) Of responding DMs, 55% are nurses, 40% work full t~me on CTs DMT, 59% reported an ~ncrease ~n their ~nst~tut~ons of PC ~nvolvement ~n CTs Only 6% of DMs sa~d PC ~nvolvement affects data quahty negatively, many felt that on-s~te monitoring results ~n h~gher standards. However, 83% sa~d PC involvement affects data quantity, several commented that much of the data collected by PCs ~s ~rrelevant Regular ws~ts of PC monitors were sa~d to be useful by 82% of respondents, and yet 54% admitted the ws~ts are annoying For CTG-PC collaborative studies, data/query flow was reported by 64% of DMs as confusing at least some of the t~me When a PC sponsors/monitors a CTG CT, 93% sa~d 25%-50% more DMT t~me ~s required

P-08 AN ANALYSIS OF DATA COLLECTION MECHANISMS

Doris Tyrrell, Dorothy R. Cline, and Ronald G. Thomas VA Medlcal Center

Palo Alto, Cahforma

Mult~center chn~cal trials require the collection of data through various mechanisms The most common method ~s the use of data collection forms Typically, each trial requires the design, development, and creation of original forms during the early stages of study planning The method of choice for the creation of these forms is a topic of some debate. Selection of a procedure raises ~ssues of cost effectiveness, ease of use, ease of training, etc To our knowledge, no rewew has been conducted of the hardware and software options and their relaWe merits available to study planners. The Cooperative Studies Program Coordinating Center at the VA Medical Center ~n Palo Alto, Cahforn~a, conducted a survey among thirty national and ~nternat~onal chn~cal thai coordinating centers The primary goals of the survey were to determine the forms development strategy used at each of the centers and what ~ssues were ~nvolved ~n choosing that strategy We present the results and g~ve recommendations concerning the selection of a data collection forms design procedure

• P-09 USE OF AN EXTERNAL LOOKUP TABLE FOR

CODING TEXTUAL DATA

Harvey Nelson, Elizabeth Yetisir, and Michael Gent McMaster University and

Hamtlton Ctvtc Hospitals Research Centre Hamtlton, Ontario, Canada

Traditionally, the use of textual data ~n chn~cal studies has been restricted because of ~ts unsuitability for statistical analys~s Instead, text on data forms was coded ~nto analyzable categoncal variables Regulatory