Clinical Trial Transparency Archives - TrialAssure

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Why Sponsors Should Use Quantitative Risk Analysis in Clinical Trial Transparency and Data Sharing

by John Gottshalk | May 2023

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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: December 7 – 20, 2019

by Staff Writer | December 2019

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This week in transparency news: June 29 – July 12, 2019

by Staff Writer | July 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

How TrialAssure Gathers Client Feedback to Build Stronger Clinical Trial Transparency Software

by Zach Weingarden | June 2019

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This week in transparency news: April 27 – May 3, 2019

by Staff Writer | May 2019

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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: April 6 – April 12, 2019

by Staff Writer | April 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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Iranian Registry of Clinical Trials (IRCT) iran trialassure

REGISTRY SNAPSHOT: Iranian Registry of Clinical Trials (IRCT)

by Staff Writer | April 2019

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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: March 23 – March 29, 2019

by Staff Writer | March 2019

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International Standard Registered Clinical/Social Study Number Registry (ISRCTN)

REGISTRY SNAPSHOT: International Standard Registered Clinical/Social Study Number Registry (ISRCTN)

by Staff Writer | March 2019

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