EMA To Explain How Trial Transparency & Data Redaction Can Live Together
The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.
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The European Medicines Agency is preparing to resume proactively publishing clinical trial data submitted by companies to support their marketing authorization applications for non-COVID-19 products.
An expert in transparency explained what drug sponsors can do to support their compliance staff in identifying commercially confidential information in accordance with the clinical trial transparency initiatives of Health Canada and the European Medicines Agency.
An analysis of publicly available information in the EU Clinical Trials Information System shows how commercial and academic sponsors differ in their approach to transparency. There are also concerns around the lack of “push back” from EU member states to address potential non-compliance.