Abstracts 279

Th~s article addresses =ssues w=th regard to costs for ~mt~al development, data entry, storage, and updating of table

• P-05 CHANGING COORDINATING CENTERS IN MIDTRIAL:

LESSONS LEARNED FROM THE IHDP

Patricia Wilkinson, Michele Donithan, and James Tonascia The Johns Hopkins Umvers~ty

Baltimore, Maryland

The Infant Health and Development Program (IHDP) ~s a mult~center, randomized trial of the efficacy of early chddhood and family =ntervent~ons =n reducing the occurrence of health, cogmt=ve, and behav=oral problems In Iow-b~rtf,-weCght ~nfants Following the enrollment of 985 =nfants and the completion of 3 years of treatment and follow-up, respons=b=l~ty for data management of the continuing follow-up of the trial cohort was transferred to Johns Hopkins University Approximately 2 months were available for planmng and preparat=on prior to assumpt=on of the thai coordmat=on Among the set of problems that such transfers present, the ones related to data management are part=cularly d=ff=cult

The design and rat=onale for the key elements of the data collection and management system that were developed during the course of the transfer are d=scussed estabhsh~ng a computerized =nventory for the trial, redes~gn=ng forms (us=ng Ventura Pubhsher), developing training and certification procedures, managing ws~t scheduhng, and ~mplement~ng database management and ~nformat~on systems (using SAS/FSP and macro language)

P-06 NEED FOR SELECTIVITY OF DATA COLLECTED

IN CLINICAL TRIALS

Denise Julian and Michael Gent McMaster Umvers~ty and

Hamilton C~wc Hospitals Research Centre Hamilton, Ontario, Canada

A cursory rewew of some of our recently completed studies ~nd~cated that substantial amounts of data collected were never used at all Such excessive data collection ~s clearly wasteful of valuable resources and ~ncreases costs of trials unnecessardy Each ~tem ~n a Case Report Form (CRF) requires careful scrutiny w~th respect to ~ts true value ~n the assessment of safety or efficacy, population description, or study management, etc It ~s recogmzed that chmcal trials of ~nvest~gat~onal new drugs have ~nherent data requirements from regulatory agencies We chose to focus on nonp~votal studies of treatments such as aspmn and coumadm, ~n our chnlcal thrombos~s research program, where data selection ~s under the total control of experienced ~nvest~gators One would expect ~n these c~rcumstances that only essential data would be collected We reviewed the CRFs for a trial evaluating prophylax~s of thromboembohsm ~n patients undergoing surgery for fractured h~p, to determine what proportion of variables collected were actually used Of the 154 variables collected, 13, such as ~dent~fiers and dates, were used only ~n study management. Of the other variables, relating to medical h~story, treatment, outcomes, laboratory data and follow-up, 52 (33 8% of total) were utilized ~n the actual publication of the results Of the remaining variables, a further 25 were considered potentially useful ~n the ~nterpretat~on of the results, leawng 64 (41 6%) that were never used for any purpose Examples of these were details of patients' medical condition and h~story, and several hematological laboratory parameters, some of which required the transportation and centrahzed processing of blood samples Even w~th the s~gnff~cant developments that have taken place ~n data management techniques and procedures, we should not lose s~ght of the need to be efficient ~n the selection of data.