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: December 19, 2020 – January 8, 2021

Transparency 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 surrounding disclosures in clinical trials. Relevant stories for this period are as follows:

The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries – 

To better understand the landscape of randomized clinical trials (RCTs) that have emerged as a response to COVID-19, a review was conducted to describe the emerging evidence base of COVID-19 RCTs by stages of disease progression, from pre-exposure to hospitalization. Several international registries were utilized to collect the data in this study. 

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EDS Patient Registries and Their Importance – 

Patient registries aim to help researchers better understand a particular disease, establish best practices, and, ultimately, find a cure. This article looks at how patient registries can help scientist learn more about a disease — EDS, in this case — and its treatment outcomes, as well as ways the disorder is managed. 

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Clinical Trial Data Sharing in The Time of COVID-19 – 

PHUSE will host their Data Transparency Winter Meeting from 3 – 5:30 pm on January 19-21 as a virtual webcast. Key topics will explore new challenges in data sharing, regulatory submissions and the exploration of technologies. Attendees will have the opportunity to participate in a joint Q&A sessionThere is no cost to join.  

Sign-up here: 

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