Increase efficiency and reproducibility in clinical trial reporting with Stata tools

Giselle Kolenic
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Giselle Kolenic: University of Michigan

Biostatistics and Epidemiology Virtual Symposium 2025 from Stata Users Group

Abstract: The Statistical Analysis of Biomedical and Education Research Group (SABER) unit of the Department of Biostatistics is an academic data coordinating center (DCC) that provides expertise in the design, conduct, and analysis of multicenter clinical trials. These trials often require reporting to Data and Safety Monitoring Boards (DSMBs), usually every six months over the course of multiple years. DSMB members are provided reports that contain tables, listings, and figures (TLFs) that summarize cumulative data for evidence of study-related adverse events, adherence to the protocol, site performance, compliance with recruitment and retention goals, and data quality, timeliness, and completeness. Stata tools can be used for consistent generation of TLFs and DSMB reports over the life of trials, increasing efficiency and reproducibility. This presentation provides an overview and illustration of some of these tools, including the putdocx Stata command.

Date: 2025-03-05
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http://repec.org/biep2025/Bio25_Kolenic.zip presentation materials (application/zip)

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Persistent link: https://EconPapers.repec.org/RePEc:boc:biep25:05

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