Collaboration with Your Data Monitoring Committee Vendor: Anticipating What Is Needed from the Sponsor Statistician

• Activity Number: 201 - Section for Statistical Programmers and Analysts P.M. Roundtable Discussion (Added Fee)
• Type: Roundtables
• Date/Time: Monday, July 29, 2019 : 12:30 PM to 1:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Emily Woolley* and David Kerr
• Companies: Axio Research and Axio Research
• Keywords: Data Monitoring Committee; Interim Data; Collaboration; Clinical Trials; Pharmaceuticals; Clinical Study Data

Abstract

As experienced statisticians from a Statistical Data Analysis Center (SDAC), we have frequent discussions with statisticians at pharmaceutical companies about expectations regarding deliverables to support a Data Monitoring Committee (DMC). In particular, statisticians at pharmaceutical companies ask “what will you expect of me?” Setting mutual expectations throughout the course of a study is imperative to ensure the correct data is available in a timely fashion for generation of reports and that the DMC has the appropriate material to make a recommendation on the continuation of the study. This roundtable will focus on how statisticians at pharmaceutical companies can anticipate requests from their SDAC vendors: Setting timelines | Understanding what data your SDAC vendor needs |Providing study documents including metadata | Establishing data transfer mechanisms | Working through challenges - Data not as expected, Delays in data transfers, Changes in structure and format, and Aligning programming in the presence of interim data | Handling mid-study updates | Confirming understanding of the data completeness and cleanliness | Agreeing on the frequency and level of QC