Abstracts 51S active regimens tended to be better than placebo and that the 3 regimens contah~g aspirin were ~cally significantly better. A cumulative meta-analysis of 13 trials done toward the end of CSP t£207 raised the issue as to whether the recta-analysis, if done earlier, would have changed the conduct of the trial. At the start of the planning period, one trial had been published with n~30 and treatment effect size (ES) -- .88 (95% CI: -.50, .61). At the time that CSP//207 was scienfificadly approved, 2 trials had been published (cum. n~- 163, ES--.31, 95 • CI-.001, .62). At the thne patient intake started, 6 tritls showed cum. n=1026, ES--.37, 959~ CI=~(.25, .50). Although the first 6- month CSP//207 progress report showed no treatment effect, by the time of the 12-month review by the Data Monitoring Board, a trend was developing in favor of active treatment. If the DMB had been privy to the meta-analysis at that time, it is conceivable they would have stopped the placebo arm. Cumulative meta-analysis could be useful as an adjunct in the planning, conduct and final analysis of a clinical trial. It could be used as one piece of evidence in the monitoring of the ongoing phase of the trial. 28A USING A RELATIONAL DATABASE MANAGEMENT SYSTEM FOR MANAGEMENT OF REVISION-DEPENDENT DATA Frances LoPresti and Evelyn D. Mirenzi Marylmtd Medical Research Instilute Baltimore, Maryland A challenging task in clinical trial data management is the efficient storage and processing of multiple revisions of form d.~+ During data entry, the data are best accessed by revision; in reporting, all a~t+, are required regardless of revision. MMRI staff have developed a method using a relational d*t~hase management system that stores all revisions of a form in a single table. The system allows the form d,tn to be accessed by revision or not depending on the application. Form a_~t, are stored in a base table. Whenever a form is revised, new items or items that have been changed are added to the base table. Items deleted from the new revision of the form continue to be stored in the base table. Items deleted from the new revision of the form continue to be stored in the base table. A relational a~t,tqme view is cre*t+ea to obtain access to ,hat+a from a specific revision of the study form. The base table is used to obtain access to a.t. for all revisions of the study form. The method used to achieve revision-indopendent storage and its effect on Coordinating Center operations will be presented. The advantages and disadvantages of adopting this method of storage will also be discussed.

28A Using a relational database management system for management of revision-dependent data

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Page 1: 28A Using a relational database management system for management of revision-dependent data

Abstracts 5 1 S

active regimens tended to be better than placebo and that the 3 regimens contah~g aspirin were ~ c a l l y significantly better.

A cumulative meta-analysis of 13 trials done toward the end of CSP t£207 raised the issue as to whether the recta-analysis, if done earlier, would have changed the conduct of the trial.

At the start of the planning period, one trial had been published with n~30 and treatment effect size (ES) -- .88 (95% CI: -.50, .61). At the time that CSP//207 was scienfificadly approved, 2 trials had been published (cum. n~- 163, ES--.31, 95 • CI-.001, .62). At the thne patient intake started, 6 tritls showed cum. n=1026, ES--.37, 959~ CI=~(.25, .50). Although the first 6- month CSP//207 progress report showed no treatment effect, by the time of the 12-month review by the Data Monitoring Board, a trend was developing in favor of active treatment. If the DMB had been privy to the meta-analysis at that time, it is conceivable they would have stopped the placebo arm.

Cumulative meta-analysis could be useful as an adjunct in the planning, conduct and final analysis of a clinical trial. It could be used as one piece of evidence in the monitoring of the ongoing phase of the trial.

28A USING A RELATIONAL DATABASE MANAGEMENT SYSTEM

FOR MANAGEMENT OF REVISION-DEPENDENT DATA

Frances LoPresti and Evelyn D. Mirenzi Marylmtd Medical Research Instilute

Baltimore, Maryland

A challenging task in clinical trial data management is the efficient storage and processing of multiple revisions of form d.~+ During data entry, the data are best accessed by revision; in reporting, all a~t+, are required regardless of revision.

MMRI staff have developed a method using a relational d*t~hase management system that stores all revisions of a form in a single table. The system allows the form d,tn to be accessed by revision or not depending on the application.

Form a_~t, are stored in a base table. Whenever a form is revised, new items or items that have been changed are added to the base table. Items deleted from the new revision of the form continue to be stored in the base table. Items deleted from the new revision of the form continue to be stored in the base table. A relational a~t,tqme view is cre*t+ea to obtain access to ,hat+a from a specific revision of the study form. The base table is used to obtain access to a . t . for all revisions of the study form.

The method used to achieve revision-indopendent storage and its effect on Coordinating Center operations will be presented. The advantages and disadvantages of adopting this method of storage will also be discussed.