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
Author : Daria Kim
The article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyses the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes innovation incentives, and that access facilitates new drug development.
These claims are characterised in terms of public-good and common-resource dilemmas. The analysis finds that confidentiality protection of primary research data plays an ambiguous role.
While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of verified and new knowledge.
It is argued that the claim of the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against the pro-access policies. The analysis proposes that regulation should adhere to the principle that protection should be confined to competition by imitation.
This implies that the rules of access should be designed in such a way that third-party use of data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximised when the ‘cooperative choice’ – i.e. when everyone shares data – becomes the ‘dominant strategy’.
This can be achieved only when access is not subject to the authorisation of the initial trial sponsors, and when primary data is aggregated, refined and managed on the collective basis.
URL : https://ssrn.com/abstract=2834493