Transparency, disclosure, data sharing, and communication 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. Relevant stories for this period are as follows:
How will national regulators in Europe impose fines for missing clinical trial results? – Transparimed
The EU Clinical Trial Regulation obliges clinical trial sponsors to submit the result of their drug trials to the Clinical Trials Information System (CTIS), a new European trial registry due to be launched in late 2021. As is already the case with the existing registry, sponsors will be obliged to make the results of drug trials public on the new registry within 12 months of trial completion (Article 37(4)). In the case of trials involving children, the timeline is 6 months. The Regulation has already been in force since May 2014. However, the Regulation will only be fully applied once CTIS goes live in late 2021.
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators – European Medicines Agency
EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics. The pilot started in December 2020. Information on the OPEN pilot is available in a Question & Answer document.
Reset default to “share” – Deloitte
Seven ways government leaders can create a culture that fuels data-sharing and open science. COVID-19 has shown that accelerated data-sharing is possible. Now the challenge for government leaders is to institutionalize these gains in data-sharing to support the next wave of innovation and public good.