Clinical Trials Transparency Archives - TrialAssure

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FDA Furthers Transparency Push with CSR Release Pilot

by Zach Weingarden | June 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: September 21 – September 27, 2019

by Staff Writer | September 2019

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National Cancer Institute Clinical Trials Reporting Program (NCI CTRP) EMA published a 27-page report this week titled Clinical data publication (Policy 0070) report Oct 2016 – Oct 2017 on the first year for implementing the policy. In that time, more than 3,000 clinical documents, or 1.3 million pages, were made publicly available on the Clinical Data Publication (CDP) website. The effort was described as “productive” and users of the website are satisfied, based on their reports. As more experience is gained, EMA expects to work with submitters on the quality of anonymization reports. trialassure software pharmatech medtech

REGISTRY SNAPSHOT: National Cancer Institute Clinical Trials Reporting Program (NCI CTRP)

by Staff Writer | September 2019

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REGISTRY SNAPSHOT: The European Union Electronic Register of Post-Authorization Studies (EU PAS Register)

by Staff Writer | March 2019

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This week in transparency news: January 5-11, 2019

by Staff Writer | January 2019

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer. Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking. Zach Weingarden, Product Solutions Manager, TrialAssure

Questions answered on FDA’s draft guidance on civil money penalties for ClinicalTrials.gov

by Staff Writer | October 2018

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Research Organizations Commit to Full Transparency

by Zach Weingarden | May 2017

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The U.S. Senate had voted in favor of an opioid bill that expands Open Payments to include payments made to Nurse Practitioners, Physician Assistants, Nurse Midwifes, Nurse Anesthetists, and Clinical Nurse Specialists, in addition to current physician reporting requirements. This will go into effect beginning January 1, 2022. Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

by Staff Writer | December 2015

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VIDEO: Clinical Trial Disclosures; More Transparency in the Future

by Staff Writer | July 2013

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