Voluntary Disclosure of High-Profile Clinical Trial Data: The Infuse Example

• Activity Number: 385
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Theodore Lystig*+
• Companies: Medtronic
• Keywords: anonymized data ; data sharing ; data transparency ; de-identification ; medical devices ; objective performance criteria

Abstract

In May 2013, the FDA published a note and request for comments in the Federal Register on the "Availability of Masked and De-identified Non-Summary Safety and Efficacy Data". The Agency is considering providing de-identified and masked preclinical and clinical data that support marketing applications. Meanwhile, the EU may soon require full disclosure of anonymized patient level clinical trial data. The EMA is currently drafting a policy on proactive access to clinical trial data that was originally scheduled for publication in November 2013. BMJ promoted the AllTrials petition to encourage trial results to be published in full and in good time. Medtronic agreed in August 2011 to provide to researchers all published and unpublished safety and efficacy data for its Infuse Bone Graft product via the Yale Open Data Access (YODA) project. In this talk I introduce the setting that precipitated Medtronic's decision to provide its data to YODA, provide an overview of the current data sharing model, consider methodological issues in working with such data, and discuss some opportunities for innovation facilitated by access to patient level data from multiple industry sponsors.