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:
Connecting while Complying: The Regulatory Trend Towards Clear Communication in Clinical Trials – SOCRA
Christopher Trudeau, JD, Associate Professor, University of Arkansas at Little Rock, presented a session at SOCRA’s 2020 Virtual Annual Conference that explored the global regulatory trend towards improving participant understanding in clinical trials. It focused on aspects of the Revised Common Rule, GDPR, EMA Policy 0070, and the EU/US Privacy Shield that mandate clear communication with trial participants.
European Medicines Agency’s interaction with industry stakeholders – EMA
EMA released is 2018-2019 annual report, discussing Brexit preparedness, EudraCT, CTIS, and more.
Swedish Research Council pledges to curb research waste – Transparimed
The Swedish Research Council has pledged to improve clinical trial reporting by its grantees. According to the Swedish magazine Curie, the Swedish Research Council currently does not explicitly require researchers it funds to make the results of their clinical trials public.
Reset default to “share:” Seven ways government leaders can create a culture that fuels data-sharing and open science – Deloitte
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.