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P23 Shift tables for presentation of clinical data
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Abstracts
individual forms and between forms. Automatic documentation, built in referencing, the ability to check for internal redundancy across forms, and the flexibility to add fields at any time without disturbing the database structure all add to the convenience and efficiency of using a relational database for the process of forms development for an RCT. Some relational database packages also allow for actual creation of forms. Such databases can readily accommodate draft and version changes. In their final stages of development, data keys can be compiled based on variable names and field types, information already contained in the database. 1"23 SHIFT TABLES FOR PRESENTATION OF CLINICAL DATA
David R. Bristol and Bruce E. Reidenberg Schering-Plough Research Institute Kenilworth, New Jersey Clinical results of therapeutic uials are often reported using a global variable "clinical response", which is based on the assessments of the changes from baseline in the severity of signs and symptoms. The clinical response is collected separately and the changes in the severity of the signs and symptoms are rarely reported. In diseases with signs and symptoms of varying specificity, reporting the changes facilitates generalization from the data. Shift tables can be used to describe these changes regardless of the categories used to make the assessments. Shift tables also provide detailed information regarding the changes in severity observed for patients within each baseline severity category. Shift tables for presentation of signs and symptoms associated with disease severity and certain elicited side effects from a recent study of two antibiotics in the treatment of otitis media are presented. P24 ROLE OF SITE AND CENTRAL LABORATORIES IN MULTIICENTER CLINICAL TRIALS: AN ILLUSTRATION FROM A VA COOPERATIVE INFECTIOUS DISEASE TRIAL
Irene M. Voynick VA Medical Center West Haven, Connecticut In an infectious disease trial by the VA Cooperative Studies Program and DOD, primary endpoint is reduction of incidence/severity of targeted infections. Critical to evaluation of efficacy is timely processing of infection cultures. The polyvalent vaccine, produced at the Swiss Serum and Vaccine Institute in Bern (SSVI), targets 33 serotypes of Klebsiella Pneum~niae and Pseudomonas Aeruginosa (K/P). The trial requires two central labs: at Walter Reed Army Institute of Research (WRAIR) for K/P isolate processing and at SSVI for vaccine serotyping. Patients from 17 sites are randomized to vaccine vs. non-vaccine treatment. During six weeks followup, suspected infections are cultured at the sites for isolates due to K/P. Since trial design allows for multiple infections/patient/day, and because of outcome dependency, a tracking procedure is used to monitor K/P occurrence and analysis. K/P infection/isolate data is collected at identification, on submission to WRAIR, and at patient outcome. By cross-referencing data fields for infection/isolate identification codes, missing data and/or isolates can be determined. In addition to the tracking procedure analytical and administrative responsibilities of the labs will be presented.
Abstracts
individual forms and between forms. Automatic documentation, built in referencing, the ability to check for internal redundancy across forms, and the flexibility to add fields at any time without disturbing the database structure all add to the convenience and efficiency of using a relational database for the process of forms development for an RCT. Some relational database packages also allow for actual creation of forms. Such databases can readily accommodate draft and version changes. In their final stages of development, data keys can be compiled based on variable names and field types, information already contained in the database. 1"23 SHIFT TABLES FOR PRESENTATION OF CLINICAL DATA
David R. Bristol and Bruce E. Reidenberg Schering-Plough Research Institute Kenilworth, New Jersey Clinical results of therapeutic uials are often reported using a global variable "clinical response", which is based on the assessments of the changes from baseline in the severity of signs and symptoms. The clinical response is collected separately and the changes in the severity of the signs and symptoms are rarely reported. In diseases with signs and symptoms of varying specificity, reporting the changes facilitates generalization from the data. Shift tables can be used to describe these changes regardless of the categories used to make the assessments. Shift tables also provide detailed information regarding the changes in severity observed for patients within each baseline severity category. Shift tables for presentation of signs and symptoms associated with disease severity and certain elicited side effects from a recent study of two antibiotics in the treatment of otitis media are presented. P24 ROLE OF SITE AND CENTRAL LABORATORIES IN MULTIICENTER CLINICAL TRIALS: AN ILLUSTRATION FROM A VA COOPERATIVE INFECTIOUS DISEASE TRIAL
Irene M. Voynick VA Medical Center West Haven, Connecticut In an infectious disease trial by the VA Cooperative Studies Program and DOD, primary endpoint is reduction of incidence/severity of targeted infections. Critical to evaluation of efficacy is timely processing of infection cultures. The polyvalent vaccine, produced at the Swiss Serum and Vaccine Institute in Bern (SSVI), targets 33 serotypes of Klebsiella Pneum~niae and Pseudomonas Aeruginosa (K/P). The trial requires two central labs: at Walter Reed Army Institute of Research (WRAIR) for K/P isolate processing and at SSVI for vaccine serotyping. Patients from 17 sites are randomized to vaccine vs. non-vaccine treatment. During six weeks followup, suspected infections are cultured at the sites for isolates due to K/P. Since trial design allows for multiple infections/patient/day, and because of outcome dependency, a tracking procedure is used to monitor K/P occurrence and analysis. K/P infection/isolate data is collected at identification, on submission to WRAIR, and at patient outcome. By cross-referencing data fields for infection/isolate identification codes, missing data and/or isolates can be determined. In addition to the tracking procedure analytical and administrative responsibilities of the labs will be presented.