EudraCT Archives - TrialAssure

trialassure data sharing EMA COVID-19 assessments Clinical Trials Information System (CTIS), a new European trial registry due CTIS EU Clinical Trial Regulation

This week in transparency news: February 8 – February 21, 2020

by Staff Writer | February 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: November 16 – December 6, 2019

by Staff Writer | December 2019

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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: July 27 – August 2, 2019

by Staff Writer | August 2019

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Federal Office for Safety in Health Care (BASG) vienna austria trialassure clinical trial registration disclosure transparency

REGISTRY SNAPSHOT: Federal Office for Safety in Health Care (BASG)

by Staff Writer | June 2019

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The Italian Medicines Agency (AIFA)

REGISTRY SNAPSHOT: The Italian Medicines Agency (AIFA)

by Staff Writer | May 2019

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TrialAssure In support of an ongoing effort to increase transparency, Health Canada intends to implement five proposals related to prescription drugs and biologics by October 1, 2018. The proposals come from a division within Health Canada—the Health Products and Food Branch (HPFB)—as part of two 2015 transparency initiatives for drugs, biologics and medical devices.

This week in transparency news: March 30 – April 5, 2019

by Staff Writer | April 2019

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european union clinical trials register trialassureclinical trial reporting clinical trial reporting

REGISTRY SNAPSHOT: European Union Clinical Trials Register (EUCTR)

by Staff Writer | March 2019

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Outsourcing-Pharma released a State of the Industry report that sheds light on the global pharmaceutical industry. One of the key findings in the report showed that more than half of survey respondents believe that industry initiatives will lead to greater transparency. The report points to a new pilot program launched earlier this year by the FDA to increase transparency. Clinical Trial Transparency Software client feedback

This week in transparency news: December 15-21, 2018

by Staff Writer | December 2018

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