Derek So – InfoDoc MicroVeille

Authors : Palmira Granados Moreno, Sarah E. Ali-Khan, Benjamin Capps, Timothy Caulfield, Damien Chalaud, Aled Edwards, E. Richard Gold, Vasiliki Rahimzadeh, Adrian Thorogood, Daniel Auld, Gabrielle Bertier, Felix Breden, Roxanne Caron, Priscilla M.D.G. César, Robert Cook-Deegan, Megan Doerr, Ross Duncan, Amalia M. Issa, Jerome Reichman, Jacques Simard, Derek So, Sandeep Vanamala, Yann Joly

Open science can significantly influence the development and translational process of precision medicine in Canada. Precision medicine presents a unique opportunity to improve disease prevention and healthcare, as well as to reduce health-related expenditures.

However, the development of precision medicine also brings about economic challenges, such as costly development, high failure rates, and reduced market size in comparison with the traditional blockbuster drug development model.

Open science, characterized by principles of open data sharing, fast dissemination of knowledge, cumulative research, and cooperation, presents a unique opportunity to address these economic challenges while also promoting the public good.

The Centre of Genomics and Policy at McGill University organized a stakeholders’ workshop in Montreal in March 2018. The workshop entitled “Could Open be the Yellow Brick Road to Precision Medicine?” provided a forum for stakeholders to share experiences and identify common objectives, challenges, and needs to be addressed to promote open science initiatives in precision medicine.

The rich presentations and exchanges that took place during the meeting resulted in this consensus paper containing key considerations for open science precision medicine in Canada.

Stakeholders would benefit from addressing these considerations as to promote a more coherent and dynamic open science ecosystem for precision medicine.

URL : Open science precision medicine in Canada: Points to consider

DOI : https://doi.org/10.1139/facets-2018-0034

Authors : Derek So, Bartha M. Knoppers

Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process.

The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval.

However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017.

Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study.

We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

URL : Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com

DOI : https://doi.org/10.1371/journal.pone.0184491