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:
FDA issues draft guidance on civil monetary penalties for ClinicalTrials.gov – FDA
The FDA issued a draft guidance this week to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer.
Read the draft guidance here.
EMA to look at companies who post trial results too late – The Pink Sheet
The European Medicines Agency (EMA) is going to be much more focused on sponsors who fail to post clinical trial results on time, according to a spokesperson. The article was drafted following a report in The BMJ by Ben Goldacre, et al, detailing lagging compliance results.
Read the full article here.
DIA hosted Global Transparency Event in London last week – Twitter
Last week, the Drug Information Association (DIA) hosted its annual Global Clinical Trials Transparency Conference in London. The conference built on prior conference discussions and leveraged learnings from International experts to provide the opportunity to gain insights on how to meet the new challenges and opportunities. TrialAssure was a sponsor of the event and shared insights from both days via Twitter.
Read the live tweets here.