IDDI WEBINAR: Patient-Level 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).

In this webinar,
- we will first review the principles, opportunities, complexities, and risks of data sharing.
- we will refer to documents from the Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations (PhRMA and EFPIA 2011), as well as a detailed report from the Institute of Medicine (2015) which discusses the principles underlying data sharing and methods aimed at maximizing benefits and minimizing the risks of data sharing. Essentially, data sharing should protect patient privacy for research participants, preserve the integrity of regulatory systems, and protect intellectual property to maintain incentives for investments in biomedical research.
- In this context, we will discuss methods of data de-identification, data standardization (e.g. CDISC), and data coding (i.e., medication procedures, adverse events).
- We will also discuss the various types of analysis that can be conducted with patient-level data.
- We will conclude the webinar 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.