Access to clinical trial data (part 2): The IMPACT Observatory and managing privacy risks

In these videos, originally part of the Cochrane Learning Live and GESI webinar series, Karmela Krleza-Jeric summarizes the ongoing evaluation of the evolution of culture and practice of various players and of research data repositories regarding the opening and access to clinical trial data conducted by the IMPACT Observatory (IMProving Access to Clinical Trial). The goal of this Observatory is to assess and inform the data sharing process and thus contribute to the opening of data.

Khaled El Emam then describes current standards and practices for the anonymization of clinical trial data, taking into account public data releases (such as the EMA Policy 0070) and data sharing through secure portals. He also summarizes significant experience that has been gained by academic medical centers and the pharmaceutical industry on how to effectively manage privacy risks.

This webinar was aimed at anyone interested to learn about what has been occurring regarding the changes of access to clinical trial data, and their potential roles in the process, including clinician trialists and reviewers and their teachers, study participants, funders, editors, consumers, regulators and other evidence users.

The webinar was delivered in March 2019 and it was organized by Cochrane’s Membership, Learning and Support Services, in partnership with the Global Evidence Synthesis Initiative (GESI). The first part of this webinar is available here

Below you will find videos from the webinar, together with accompanying slides to download [PDF]. 

Part 1: IMPACT Observatory: methodology, scoping review, interviews, and surveys

Part 2: Principles of De-identification

Part 3: IMPACT Observatory cont.: Initiatives, Repositories, Conclusion

Presenter bio:

Dr Karmela Krleza-Jeric (MD., MSc., PhD), is leading the IMPACT Observatory, hosted by MedILS. Her research interests are related to opening of research data and its impact on research, research integrity, reliability of evidence, creation of knowledge. Her present research focuses on the analysis of the dynamics of opening of clinical trial data including barriers and facilitators, and the role of various players and knowledge users and its impact on research. More info can be found here

Khaled El Emam is the founder and CEO of Privacy Analytics. El Emam is also a senior scientist at the Children’s Hospital of Eastern Ontario (CHEO) Research Institute and Director of the multi-disciplinary Electronic Health Information Laboratory (EHIL), conducting academic research on de-identification and re-identification risk, and a Professor in the Faculty of Medicine at the University of Ottawa.

Part 1: IMPACT Observatory: methodology, scoping review, interviews, and surveys

Part 2: Principles of De-identification

Part 3: IMPACT Observatory cont.: Initiatives, Repositories, Conclusion


Author information: 
Krleza-Jeric, Karmela; El Emam, Khaled