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Should people share their DNA for drug development purposes? – USA Today Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.

This week in transparency news: May 2 – May 15, 2020

by Staff Writer | May 2020

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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 ClinicalTrials.gov 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: April 18 – May 1, 2020

by Staff Writer | May 2020

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This week in transparency news: April 4 – April 17, 2020

by Staff Writer | April 2020

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FORMER GILEAD SCIENCES HEAD OF CLINICAL TRIAL DISCLOSURE AND DATA TRANSPARENCY JOINS MMS AND TRIALASSURE AS DIRECTOR OF GLOBAL TRANSPARENCY STRATEGY AND COMPLIANCE

by Staff Writer | April 2020

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TRIALASSURE TRANSPARENCY SUITE WINS DATA SOLUTION OF THE YEAR—HEALTHCARE IN THE 2020 DATA BREAKTHROUGH AWARDS

by Staff Writer | April 2020

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As Universities and Academic Institutions Face Unique Challenges in Reporting Clinical Trials, TrialAssure Responds by Offering Free Clinical Trial Transparency Tool

by Staff Writer | April 2020

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CSR pilot FDA releases first clinical study report in data transparency pilot program trialassure fdaaa section 801 requirements fdaaa trials tracker

This week in transparency news: March 20 – April 3, 2020

by Staff Writer | April 2020

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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 ClinicalTrials.gov 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: March 7 – March 19, 2020

by Staff Writer | March 2020

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Committed to the health of your projects during COVID-19

by Staff Writer | March 2020

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This week in transparency news: February 22 – March 6, 2020

by Staff Writer | March 2020

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