Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
REPORT: Clinical trials in the European Union – TranspariMED; Health Action International
Important information on clinical trials remains hidden from public and scientific scrutiny, even where research is publicly funded. This report discusses transparency concerns related to the current European Union trial registry and the forthcoming clinical trials portal and database, and lays out several policy recommendations for trial registration, summary results, and access to clinical study reports.
Download the full report at Health Action International
Clinical trials regulation and the General Data Protection regulation: some questions answered – European Data Protection Board
The European Data Protection Board issued guidance on clinical trials regulation and the General Data Protection Regulation (GDPR) in the European Union. This guidance comes after the implementation of GDPR and seeks to clarify some common questions.
Read the full guidance here
How pharma is tightening up data privacy and security – MM&M
This article discusses privacy of data in depth, and the awareness of the pharma and healthcare sectors of the potential privacy threats as new regulations form to fix this issue. Touching on concerns related to data ownership, the author cites the importance of data anonymization as well as data sharing platforms like Vivli as ways that “pharma and healthcare organizations will look like good actors several years down the road.”
Read the full article by Larry Dobrow