This week in transparency news: March 16 – March 22, 2019

by Staff writer,
Posted on 3/22/2019

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:

Health Canada starts releasing protected drug and medical device data –CBC

Until recently, clinical trial and medical device submission data was not fully available to the public and restricted to particular researchers in Canada. Now, data about medical devices and drugs are starting to be posted online via Health Canada’s new Clinical Information Portal.

Vik Adhopia has the full story via CBC

WHO panel calls for registry of all human gene editing research Reuters

In reaction to the controversy surrounding a Chinese scientist’s claims of editing the genes of twin babies, a WHO panel of gene editing experts formed and met in Geneva this week to discuss transparency issues on the matter. The panel said a central registry of all human genome-editing research was needed “in order to create an open transparent database of ongoing work.”

Read the full article by Kate Kelland

UK offers more no-deal Brexit Guidance on clinical trials, PIPs Regulatory Focus

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on registering clinical trials, publishing trial results, and applying for Pediatric Investigation Plans (PIPs). Trials must be registered on a publicly-accessible database within six weeks from the recruitment of the first participant, the guidance says.

Read Zachary Brennan’s full story on Regulatory Focus

Don’t get too comfortable with your technology vendors and applications Forbes

TrialAssure’s CIO Mohamad Zahreddine outlines why organizations should have a clear vendor and application life cycle management (ALM) strategy. Zahreddine explains that change may be difficult, especially when updating current systems or switching vendors, but necessary to grow a business or stay competitive.

Read Mohamad Zahreddine’s article via Forbes Technology Council

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