Data-sharing and re-analysis for main studies assessed by the European Medicines Agency-a cross-sectional study on European Public Assessment Reports.

Background: Transparency and reproducibility are expected to be normative practices in clinical trials used for decision-making on marketing authorisations for new medicines. This registered report introduces a cross-sectional study aiming to assess inferential reproducibility for main trials assessed by the European Medicines Agency.

Methods: Two researchers independently identified all studies on new medicines, biosimilars and orphan medicines given approval by the European Commission between January 2017 and December 2019, categorised as 'main studies' in the European Public Assessment Reports (EPARs).

Medical journal requirements for clinical trial data sharing: Ripe for improvement.

Florian Naudet and co-authors discuss strengthening requirements for sharing clinical trial data.

Intent to share Annals of Internal Medicine's trial data was not associated with data re-use.

Objective: To explore the impact of the Annals of Internal Medicine (AIM) data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data).

Funders' data-sharing policies in therapeutic research: A survey of commercial and non-commercial funders.

Background: Funders are key players in supporting randomized controlled trial (RCT) data-sharing. This research aimed to describe commercial and non-commercial funders' data-sharing policies and to assess the compliance of funded RCTs with the existing data-sharing policies.

Methods And Findings: Funders of clinical research having funded at least one RCT in the years 2016 to 2018 were surveyed.

Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations.

Objective: To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.

Design: A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).

Setting: ICMJE website; PubMed/Medline.

[Data sharing policies of clinical trials funders in France].

Aims: The aims of this survey were to evaluate the percentage of French clinical trial funders with a data sharing policy, to describe their data sharing policies and, more generally, the transparency of the research they fund.

Methods: The different funders of clinical trials in France have been identified from 3 lists of tenders for clinical research projects: the internal list of the University Hospital Center (CHU) of Rennes, the list of the Interregional Group for Clinical Research and Innovation (GIRCI EST), the list of the portal for calls for projects in health research. Funders were contacted, first by email and then by phone (at least two email and/or phone reminders) to respond to an online survey via Google form.