Clinical Trial Transparency Policy

Clinical trials are conducted in almost every country in the world, each with its own health authority and regulations. Approximately 90 of these countries have requirements related to the disclosure of clinical trial data that are made publicly available on over 30 clinical trial registries. Complying with all regulations is the minimum disclosure requirement. However, there are no global standards for the scope and timing of these disclosure requirements, making it difficult for sponsors to obtain a consistent view of how their studies comply with local regulations. Adding to this complexity are the evolving expectations from transparency advocates and patient groups, as well as the general industry trend to disclose an ever-increasing scope of clinical data.

Responsible data sharing advances scientific understanding and supports better research decisions, leading to faster insights that, in turn, help patients. Additionally, greater transparency holds the promise of:

• Improved trust in the industry
• Better relationships with patients, patient groups, and researchers
• Positive investor evaluations of companies based on their commitment to transparency, which is perceived to reduce certain risks and reflects a company’s ethics

To satisfy the changing regulatory requirements, and to address the evolving expectations of patient groups, transparency advocates, and industry trends, a transparency policy must clearly define the following commitments related to disclosure, transparency, and data sharing.

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