Expert Working Group on Confidentiality of Interim Results

  • Dates: 11 May, 2017

The confidentiality of interim results of on-going trials is a topic on the agenda of the EMA Biostatistics Working Party (BSWP).  ICH E9 states that all staff at the investigational sites and at sponsor (except those directly involved with the execution of an interim analysis) should remain blinded to any interim analysis results. The BSWP recognised that this advice may need to be re-evaluated, especially for some complex situations (eg the use of interim analyses in Cardiovascular Outcomes Trials to rule out harm or for gene therapy where the full results may not be available for 15 years).

The BSWP therefore asked the PSI/EFSPI Regulatory Committee to set up a PSI/EFSPI expert working group on this topic and to provide thoughts and recommendations.  The expert working group has been formed under the leadership of Jürgen Hummel (PPD), Erika Daly (ICON) and Robin Mukherjee (Astra Zeneca), and are planning to meet face to face on 11 May with the aim to get back to the BSWP by September 2017.

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