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:
As Universities and Academic Institutions Face Unique Challenges in Reporting Clinical Trials, TrialAssure Responds by Offering Free Clinical Trial Transparency Tool—TrialAssure
TrialAssure announced that it will offer academic institutions free access to TrialAssure REGISTRY—the premiere clinical trial disclosure reporting application. This offer is limited to the registry configurations for ClinicalTrials.gov, the US Food & Drug Administration (FDA) clinical trial registry, and it includes one upgrade per year, keeping with technological advancements and any US regulatory updates or changes to registry requirements.
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Eudamed’s delay and its impact on clinical investigations under the EU MDR– Regulatory Focus
Focusing on the delay in launching the European Union’s new electronic database, the author explores the ramifications and potential issues caused by inaccessible clinical investigation data for medical devices. Until this database is launched, sponsors are recommended to post the data on other databases to meet transparency requirements.
Raquel Billiones, PhD has the full story
NYU and Yale collaboration leads to ruling that will reveal decade of undisclosed clinical trial data—New York University (NYU)
NYU Law’s Technology Law and Policy Clinic (TLP) and Yale Law School’s Media Freedom and Information Access Clinic (MFIA) represented plaintiffs in a recent court ruling that closed a longstanding loophole that allowed clinical trial sponsors to withhold unfavorable trial results for studies completed between 2007 and 2017. This NYU-Yale collaboration argued that federal agencies, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Department of Health and Human Services (DHHS), misinterpreted the Food and Drug Administration Amendments Act (FDAAA).
Read the article by Jade McClain
Answers to Questions from Responsible Parties on Submitting Information to ClinicalTrials.gov Related to Coronavirus (COVID-19) Available—ClinicalTrials.gov
ClinicalTrials.gov published its “Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19)” document. The organization notes that this document will be updated as needed.
Read the document here
