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The Hidden Implications of Clinical Trial Disclosure Noncompliance

 
• By Thomas Wicks

Potential fallout from noncompliance goes well beyond regulatory penalties; adherence has improved but less so for smaller companies.

magnifying glass pie chart data examination transparency
Compliance with clinical trial disclosure requirements varies widely in biopharma. • Source: Shutterstock

Over the past decade, industry sponsors of clinical trials have expanded their commitments to data transparency, and overall compliance with trial disclosure regulations is markedly better. However, most of these improvements have been made by the larger companies. Many smaller biopharmaceutical organizations are reluctant to share data more broadly and remain significantly noncompliant with clinical trial disclosure regulations.

With increasing attention to clinical data transparency practices and the growing likelihood of negative consequences for nondisclosure, industry sponsors of...

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