Researchers examined current safety data collection standards and processes, including classification and analysis across several investigational sponsored clinical trials. They developed strategies for harmonizing data collection and reporting to facilitate data sharing and evaluation across NIH-sponsored studies. The evaluation focused on issues underlying the cross-trial analysis of cerebro- and cardio-vascular risks associated with celecoxib use in six clinical studies. The working group for this collaborative effort involved National Cancer Institute, Brigham and Women´s Hospital´s Clinical Endpoint Committee, Statistics Collaborative, Inc, and CCS Associates.
Researchers developed two Manuals of Operations which defined the scope of the project and provided details pertaining to the processes for data standardization and harmonization as well as document collection, database development, event adjudication, data analysis, and data distribution. Plans were collected and reviewed for all six studies.
All of the plans met FDA and/or NIH requirements though none included provisions for real-time access to data for safety or other analyses. With advances in technology and accessibility to secure and web-based electronic data management systems containing investigational safety data, such objectives may be achieved.
Report Title: Evaluation of the Process for Collection, Classification, and Analysis of Safety Data Across NIH-sponsored Clinical Trials (CTSA). Report may be obtained from Federal Contact
Agency Sponsor: NIH, National Institutes of Health
Federal Contact: Ernest Hawk, MD, 301-496-8537
Performer: CCS Associates
PIC ID: 8748