italy FDA EMA HC PRCI phuse data transparency nhs us uk eu make it public ctis eudract who World Health Assembly Update NIHR policy on registration and disclosure of clinical trial results – National Institute for Health Research NIHR researchers introduced a new policy on clinical trial transparency. The policy aims to improve trial registration and results disclosure to ensure full transparency of clinical trials funded by the NIHR. Additionally, clinical trials—along with all other research studies—must comply with the NIHR’s data sharing requirements. 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. The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit. Policy 0043 – a policy which gave access to EMA’s archived documents – is now limited to use by European Union citizens only. Additionally, excessive workload is said to be the cause for cutbacks, including the suspensions of publishing new data packages as a part of Policy 0070. The article states that this is a major interruption of the important transparency initiatives that need to be continued. World Health Organization (WHO) website, 12 of the world’s largest medical research funding agencies and international organizations pledged to implement policies within 12 months that mandate the registration and public disclosure of results for all trials they fund, co-fund, sponsor, or support. Among the signatories are the two largest private medical research funders in the world, the Gates Foundation and the Wellcome Trust. The announcement comes on the heels of the NIH Final Rule governing disclosures, which went into effect in January, and underlines the commitment toward transparency of the international research community. Referencing the 2013 Declaration of Helsinki, Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure will be bringing a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows: Senator introduces legislation to amends Sunshine Act – Policy & Medicine Senator Claire McCaskill proposed the Patient Advocacy Transparency Act of 2018 this week that widens Open Payment reporting and amends the Physician Payment Sunshine Act

This week in transparency news: May 30 – June 12, 2020

Clinical trial transparency in the pharmaceutical industry is continually evolving, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Select recent and relevant stories are as follows:

EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication –

“In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA) Executive Director Guido Rasi said the agency is trying to figure out how to be transparent with regard to clinical trial data for products it reviews to treat or prevent coronavirus disease (COVID-19).”


International community joins WHO in supporting open COVID-19 research, science – Homeland Preparedness News

More than 30 countries and international partners/institutions have rallied behind the COVID-19 Technology Access Pool (C-TAP), a new initiative from the World Health Organization (WHO) and Costa Rica designed to make scientific tools to fight COVID-19 universally available. Specifically, it calls for public disclosure of gene sequences and data and transparency in the publication of clinical trial results, among other things.

Read more on open COVID-19 research

New transparency webinar offered for free – MMS Holdings and TrialAssure

This Expert Insights webinar will focus on key elements of current transparency regulations, including the background and history of the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) requirements for the publication of clinical trial data. Key requirements of both health authorities will be discussed in-depth, including similarities and differences. Additionally, attendees will learn about the future of document sharing and what will be required to disclose publicly in the years to come.

Register and learn more here

Share Other Health Data In Real-Time Like It’s A Pandemic – ReadWrite

Near real-time data-sharing on the COVID-19 cases as they come in has been at the forefront of the fight against the pandemic. Particular countries without the privacy restrictions of the U.S. or Europe are sharing detailed patient information, not only with physicians, but the public to help each individual work with the best information. The countries who have thus far proven to be the most effective in fighting COVID-19 are also the ones that have invested heavily in data-sharing capabilities.

Learn about data sharing in Singapore

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