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P62 Preditor: An organized and efficient approach for ensuring data quality in a clinical trial
Abstracts
453
P62 PREDITOR: AN ORGANIZED AND EFFICIENT APPROACH FOR ENSURING DATA QUALITY IN A CLINICAL TRIAL Jeffrey Martin, David Burry, Gerald Swanson, Kimberly Beringer, Sharon Crow, Regina Hardison, Gail Harger, Margaret Cooper, Andrea Siewers
University of Pittsburgh Pittsburgh, Pennsylvania The analysis of clinical trial data is only as good as the integrity of the data collected. For the Bypass Angioplasty Revascularization Investigation (BARI) at the Epidemiology Data Center, data integrity verification has been a laborious process as well as cosily with respect to EDC resources: personnel, time, and computer fees. BAR] processes hundreds of complex edit procedures on data collected involving 20 data forms for more than 4000 patients. Over the past several years, the EDC has targeted its data editing computer systems to develop a more organized and efficient approach. PREDITOR is this new approach. The PREDITOR system is comprised of three modules: an Edit Development Environment (EDE), an Edit Processing System (EPS), and an Edit Reporting System (ERS). EDE is a menu-drivendevelopment environmentthrough which creating, updating, and testing edit macros has been simplified. EPS is a table driven edit processing system that efficiently locates data conflicts and captures them to an edit errors table. Intelligence is built-in to isolate and process only new and modified patient data since the last scheduled edit processing. Edit macros are executed individually to ensure eontinning edit processing should an edit macro fail. A fully integrated edit bypass system eliminates redundant error reporting for data contliets that cannot be resolved. ERS is a flexible reporting mechanism which gives data management personnel the ability to generate error reports independent of the editing process. The error reports are tailored by one or more report variables (i.e., site, form, edit, and patient). By implementing this new approach, BARI has successfully reduced edit processing time from several days to a few hours as well as reduced the amount of effort required in implementation of new edit macros. PREDITOR's increased efficiency and organization has freed EDC resources for utilization in other aspects of a clinical trial. P63 DESIGN OF A RANDOMIZED TRIAL OF COMBINED NUCLEOSIDE ANALOG ANTIRETROVIRAL THERAPY IN AIDS PATIENTS
Timothy Church, Marjorie Dehlinger, Louis Saravolatz, Daniel Stein, Dean Winslow, and Gary Collins
University of Minnesota Minneapolis, Minnesota
A randomized, partially double-blind, 3-arm trial comparing therapies using a combination of either didanosine (ddl) or dideexycytidine(ddC), two different nucleoside analog anti-retroviral drugs, with zidovudine (ZDV) to a therapy using ZDV alone began accruing subjects in April 1992 with a target enrollment of 1200 patients within one year. The sample size was based on a 30% reduction in the primary outcome, 2-year rate of disease progression (including death), with 80% power for a global test of significance at the 5% level. Secondary outcome measures are toxicity and CD4+ counts. The patient and physician are masked to whether the patient is receiving single-drug-phis placebo or two-drug therapy, but are aware of whether ddl/placebo or ddC/placebo is assigned to keep the number of pills and pill bottles manageable. The 14 participating centers are geographically dispersed and serve socioeeonomicallydiverse groups as well. Enrollment as of November 30, 1992 is 528 ranging from 2 to 80 subjects per center, with 6% female, 34% non-white and 17% reporting prior intravenous drug use.
453
P62 PREDITOR: AN ORGANIZED AND EFFICIENT APPROACH FOR ENSURING DATA QUALITY IN A CLINICAL TRIAL Jeffrey Martin, David Burry, Gerald Swanson, Kimberly Beringer, Sharon Crow, Regina Hardison, Gail Harger, Margaret Cooper, Andrea Siewers
University of Pittsburgh Pittsburgh, Pennsylvania The analysis of clinical trial data is only as good as the integrity of the data collected. For the Bypass Angioplasty Revascularization Investigation (BARI) at the Epidemiology Data Center, data integrity verification has been a laborious process as well as cosily with respect to EDC resources: personnel, time, and computer fees. BAR] processes hundreds of complex edit procedures on data collected involving 20 data forms for more than 4000 patients. Over the past several years, the EDC has targeted its data editing computer systems to develop a more organized and efficient approach. PREDITOR is this new approach. The PREDITOR system is comprised of three modules: an Edit Development Environment (EDE), an Edit Processing System (EPS), and an Edit Reporting System (ERS). EDE is a menu-drivendevelopment environmentthrough which creating, updating, and testing edit macros has been simplified. EPS is a table driven edit processing system that efficiently locates data conflicts and captures them to an edit errors table. Intelligence is built-in to isolate and process only new and modified patient data since the last scheduled edit processing. Edit macros are executed individually to ensure eontinning edit processing should an edit macro fail. A fully integrated edit bypass system eliminates redundant error reporting for data contliets that cannot be resolved. ERS is a flexible reporting mechanism which gives data management personnel the ability to generate error reports independent of the editing process. The error reports are tailored by one or more report variables (i.e., site, form, edit, and patient). By implementing this new approach, BARI has successfully reduced edit processing time from several days to a few hours as well as reduced the amount of effort required in implementation of new edit macros. PREDITOR's increased efficiency and organization has freed EDC resources for utilization in other aspects of a clinical trial. P63 DESIGN OF A RANDOMIZED TRIAL OF COMBINED NUCLEOSIDE ANALOG ANTIRETROVIRAL THERAPY IN AIDS PATIENTS
Timothy Church, Marjorie Dehlinger, Louis Saravolatz, Daniel Stein, Dean Winslow, and Gary Collins
University of Minnesota Minneapolis, Minnesota
A randomized, partially double-blind, 3-arm trial comparing therapies using a combination of either didanosine (ddl) or dideexycytidine(ddC), two different nucleoside analog anti-retroviral drugs, with zidovudine (ZDV) to a therapy using ZDV alone began accruing subjects in April 1992 with a target enrollment of 1200 patients within one year. The sample size was based on a 30% reduction in the primary outcome, 2-year rate of disease progression (including death), with 80% power for a global test of significance at the 5% level. Secondary outcome measures are toxicity and CD4+ counts. The patient and physician are masked to whether the patient is receiving single-drug-phis placebo or two-drug therapy, but are aware of whether ddl/placebo or ddC/placebo is assigned to keep the number of pills and pill bottles manageable. The 14 participating centers are geographically dispersed and serve socioeeonomicallydiverse groups as well. Enrollment as of November 30, 1992 is 528 ranging from 2 to 80 subjects per center, with 6% female, 34% non-white and 17% reporting prior intravenous drug use.