This week in transparency news: December 5 – December 18, 2020 

by Staff Writer

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. 

Patient Advocacy Group Leaders Tell How Data Sharing Can Help with Understanding Rare Diseases in New Video – rarediseases.org 

Natural history studies provide health care professionals and researchers with first-hand information about people living with rare diseases and give insight into how rare diseases present, progress over time and impact patients. Data sharing supports patients by helping the community understand their disease better, which helps improve clinical care and can accelerate the development of new treatments. 

Watch the video on Raredisease.org 

The Lost Decade: Clinical Trials Data Access After Seife v HHS – AJMC.com 

A 2020 federal court ruling requires clinical trial sponsors to report a decade’s worth of previously exempted data to the National Institutes of Health (NIH) for publication on ClinicalTrials.gov. In Seife v HHS, the US District Court for the Southern District of New York invalidated NIH regulations that exempted certain clinical trials conducted between 2007 and 2017 from results reporting requirements mandated by the Food and Drug Administration Amendments Act.

Read more on ajmc.com  

2020 Progress Report: Clinical Trial Data Sharing in The Time of COVID-19 Vivli.org 

This progress report discusses how coronavirus treatments are being accelerated through data sharing, leading-edge research that re-uses clinical trial data, novel research projects, and creating impact through data sharing. 

View the full report on vivli.org

From publication bias to lost in information: why we need a central public portal for clinical trial data  BMJ Journals 

The availability of clinical trial records has increased markedly. This article outlines the challenges faced in information retrieval for evidence syntheses and provides a proposal for ensuring efficient and complete access to clinical trial records, namely, the establishment of a central, worldwide public portal. 

Read more on ebm.bmj.com 

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