Patient-Level Data Sharing in Clinical Research

February 16, 2016

IDDI organized a webinar on Patient-Level Data Sharing in Clinical Research. Our experts from IDDI and GSK spoke about principles, opportunities, complexities, and risks of clinical data sharing.

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Patient-Level Data Sharing in Clinical Research

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IDDI organized a webinar on Patient-Level Data Sharing in Clinical Research. Our experts from IDDI and GSK spoke about principles, opportunities, complexities, and risks of clinical data sharing.

The last five years mark the beginning of a revolution in clinical research: data collected on patients treated in clinical trials to support approval of new drugs and devices, which for a long time were considered confidential, will from now on be shared with a view to enhancing public health and informing future research. In 2013, the European Medicines Agency set a new standard for clinical trial data transparency by enabling interested parties to request data from clinical trials submitted for marketing authorization of medicinal products, including patient-level data (European Medicines Agency 2013). This followed a previous policy of this agency on access to clinical trial documents (Bonini et al, 2014).

Contents:
  • The principles, opportunities, complexities, and risks of data sharing were reviewed.
  • The webinar was concluded by discussing future perspectives, including full access to all data, including biomarker and –omic data, access to analysis code for reproducible research, involvement of principal investigators in the research process, and access to data from academic trials.

Speakers:

  • Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
    Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe.
  • Frank Rockhold, PhD, Senior Vice President, Safety and Pharmacovigilance, GlaxoSmithKline and Professor of Biostatistics and Bioinformatics, Duke University.
    He holds a PhD in Biostatistics from the Medical College of Virginia. He has chaired the GSK operations and governance board for data disclosure, which covers disclosure of protocols, clinical trials summaries, study reports as well as individual patient level data.
Presentation of the Webinar: Patient-Level Data Sharing in Clinical Research

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