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: November 21 – December 4, 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.

COVID-19 vaccine registry launched by Mayo to ID those interested in clinical trials WIZM News Talk

Mayo Clinic has launched a COVID-19 Vaccine Registry for those interested in participating in upcoming COVID-19 vaccine clinical trials. Currently, with more than 150 vaccine candidates in preclinical evaluation and more than 40 in clinical trials worldwide, Mayo Clinic is still accepting names to the registry who may be contacted in the future to determine if they are eligible to participate in a COVID-19 vaccine trial at Mayo Clinic.


How pharma can build trust in COVID-19 vaccines: Transparency on trials and side-effects The Conversation

Promising results from large clinical trials testing three vaccines to prevent COVID-19 bring us a step closer to a widely available vaccine. Polling in the United States and Canada reveals increasing distrust of COVID-19 vaccines, but as vaccine developers and sponsors of ongoing trials, pharmaceutical companies are uniquely situated to help promote public trust in COVID-19 vaccines.


Research Community Alert – NIH Finalizes Updated Data Sharing Policy The National Law Review

The National Institutes of Health (NIH) issued its final NIH Policy for Data Management and Sharing (the DMS Policy), which updates and replaces the 2003 NIH Data Sharing Policy. The DMS Policy sets forth a number of standards for good data management practices and data sharing expectations applicable to research funded by NIH.

Read more on The National Law Review

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