of the Application) This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the Interstitial Cystitis Clinical Trials Group (ICCTG). The proposed DCC will provide administrative, biostatistical, urological, pathological, clinical data management and researc computing leadership for the ICCTG in the conduct of a series of randomized, controlled clinical trials (RCTs) at five Clinical Research Centers (CRCs) to investigate current and novel medical therapies for Interstitial Cystitis (IC) During Phase 1, the DCC will guide the design of ICCTG master protocols, including decisions related to baseline screening and data collection on symptoms, quality of life, and laboratory specimens, and during Phase 11, the DCC will guide the conduct of multiple RCTs. The DCC will provide expertise in the design and conduct of clinical trials, pain measurement, selection of outcome measures, and identification of prognostically different subgroups of patients. Based on completed analyses of data from the Interstitial Cystitis Data Base (ICDB) Study, as well as extensive new analyses underway at the CCEB a) identification of clusters of biopsy feature subgroups, b) correlating symptoms, clinical findings & family/medical history with biopsy specimen features), this DCC is uniquely positioned to provide valuable experience-base biostatistical leadership for the ICCTG during the planning phase of these clinical trials. The DCC will provide the clinical trials and biostatistics expertise for conducting specific clinical trial protocols, as illustrated by the two Protocols included in this proposal. To support these multi-center, multiple protocol RCTs, the DCC will provide the data management and research computing expertise necessary to design and implement data quality assurance, reporting and data collection via a secure World Wide Web (WWW)-based data management system, deployed on existing hardware at the CRCs, to facilitate data entry, verification and validation at the CRCs, and data transmission ove the Internet to the server at the DCC. This system will support subject enrollment, randomization and data collection at the CRCs, and tracking of subjects, data, and specimens at the DCC. The DCC will execute procedures for data security and access, data quality control, storage and back-up, and will provide periodic reports of accrual, follow-up, and data. The DCC will also provide the logistical and administrative support for the conduct of all multi center RCTs. The DCC will organize meetings of the Steering Committee, coordinate the development and distribution of the Protocol and Manual of Operations for each of the clinical trials, and provide the NIDDK Program Office, Steering Committee, External Advisory Committee, and Data and Safety Monitoring Board with interim data summaries, final statistical analyses and collaboration on all scientific publications.
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