Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories surrounding disclosures in clinical trials. Relevant stories for this period are as follows:
The Court confirms the right of access to documents contained in the file of a marketing authorization application for a medicinal product – Court of Justice of the European Union
The Court of Justice of the European Union was recently asked to examine the access of European Union documents submitted for marketing authorization applications. An objection to accessing these documents—the Court explained—must detail the nature of the data “whose disclosure would undermine commercial interests.”
Read the full press release
New advanced search fields – ClinicalTrials.gov
ClinicalTrials.gov had included new features to the database. Two new fields have been added to the Advanced Search page: Results First Posted and Results Submitted.
Visit ClinicalTrials.gov for all the updates
Patient and health groups urge UK parliament to stay engaged on clinical trial reporting – TranspariMED
Despite increased clinical trial transparency measures in 2018 and 2019, the UK has yet to introduce a national reporting system, sparking reactions from patient and health groups. These groups are urging the newly-elected Chair of the House of Commons Science and Technology Committee to “continue engaging on the issue of clinical trial transparency in the new Parliament.”
Till Bruckner has the full story
