Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies

• Activity Number: 60 - Real World Evidence in Regulatory Decision Making: Past, Current and Future?
• Type: Topic Contributed
• Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
• Sponsor: Health Policy Statistics Section
• Author(s): Shirley Wang*
• Keywords: Transparency; Reproducibility; Healthcare database ; Real world evidence; Real world data

Abstract

The International Society for Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), two leading professional societies that work intensely with healthcare databases to assess the use and value of drugs, found the issue of transparency and reproducibility of database research to be so critically important that they convened a joint task force to develop a set of papers that provide recommendations on good procedural practices as well as specific reporting to facilitate reproducibility and assessment of validity.

This session will focus on the paper "Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0". Defining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. This paper summarizes a catalogue of specific scientific decisions that underpin study execution. These should be reported to facilitate replication and enable validity assessment for studies conducted in large healthcare databases.