This week in transparency news: December 8-14, 2018

by Staff writer,
Posted on 12/14/2018

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:

Lawsuit Filed Against FDA for Not Following Law on Reporting of Clinical Trial DataBioSpace

A lawsuit filed by Peter Lurie, an ex-associate commissioner for public health strategy and analysis with the U.S. Food and Drug Administration (FDA), alleges in a lawsuit that the regulatory agency relaxed reporting requirements for clinical trials completed prior to the final rule transition date on products that were not yet approved, and that this was contradictory to the law.

Read the details on the clinical trial data lawsuit.

What the California Wildfires Can Teach Us about Data Sharing WIRED

This article discusses air quality issues from the California wildfires in last 2018 and how open data sharing is an answer to keeping more people safe – as it has in other natural disasters. They go on to say that “Pharmaceutical firms, for instance, use the data to develop drugs that save lives, but they could save more lives if their data were shared… Open data will be key to modernizing the clinical trial process and integrating AI and other advanced techniques used for analyses, which would greatly improve health care in general.”

Read more about data sharing.

Next month: CBI’s 6th Annual Disclosures and Transparency Conference CBI

CBI’s 6th Annual Clinical Data Disclosure and Transparency conference is set to gain industry perspectives that help: Navigate EU Clinical Trial Regulation and Its Impact, Assess the Impact that GDPR has on the Collection and Sharing of Clinical Trial Data, Examine the New September 2018 Draft Guidance from the FDA under Section 402(j) of the Public Health Services Act, Gain Insight from Different Perspectives on How Each Utilize Clinical Data and View Data Sharing, Explore Platforms Available for Data Sharing. Speakers from Teva Pharmaceuticals, Otsuka, Eli Lilly, The Michael J. Fox Foundation for Parkinsons Research, and more will be sharing their insights.

Register for the transparency event.

Zach Weingarden contributed to this round-up.

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