Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
EMA published guidance on the publication of clinical data – European Medicines Agency
The External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use covers guidance on the procedural aspects of the submission of clinical reports, the anonymisation of clinical reports and the identification and redaction of commercially confidential information in clinical reports. It also includes a checklist for the ‘Redaction Proposal Document’ package.
Read the full guidance document here.
Sharing data from failed drugs to speed up research – Nature.com
Authors Enrica Alteri and Lorenzo Guizzaro explain how sharing data and evidence from unsuccessful clinical trials can help bring drugs to market quicker. The article points to Alzheimer’s research, where 99.6 percent of clinical trials from 2002 to 2012 failed to produce a new drug.
Read the full piece here.
CBI hosting its 6th Annual Disclosure and Transparency event – CBInet.com
CBI’s Clinical Data Disclosure and Transparency event will be held in Philadelphia on January 29-30, 2019. The agenda will laser focus on the implications of and approaches being taken for data sharing, ensuring compliance with regulations, navigating disclosure requirements, and releasing patient-level data. Speakers from Otsuka, Teva Pharmaceuticals, Portola Pharmaceuticals, Johnson & Johnson, and more are planned to speak.
View the full speaker list here.
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