Beyond Compliance: Operationalizing Disclosure Intelligence For Compliance At Scale

By Thomas Wicks

In the ever-evolving landscape of regulatory changes, marketing authorizations, study design, and public disclosure of clinical trials are significantly impacted. Forward-thinking organizations integrate transparency best practices into their core processes, embracing "disclosure-by-design" as a guiding principle. This approach ensures enhanced consistency across study documentation, reducing risks associated with evolving regulations, noncompliance, and the unexpected publication of sensitive content.

The significance of these practices is underscored by the fact that over 90 countries mandate the public disclosure of clinical trial information. Health authorities worldwide are actively sharing their enforcement plans and penalties. In the United States, noncompliance fines can exceed $14,000 per day per trial, while in Europe, fines of up to €500,000 and imprisonment for up to three years may be imposed by 14 European Economic Area (EEA) member states, notably Belgium.

Financial penalties are just one aspect of the regulatory landscape; risks extend to strategic business functions. Public disclosure before patent application submission can lead to patent rejection, and perceived ethical breaches can result in reputational damage. Scrutiny during acquisition due diligence can extend timelines and diminish valuations.

Navigating the global clinical trial disclosure landscape requires a nuanced understanding of cultural and regulatory diversity. Regulators, such as the US FDA and UK Health Research Authority, are increasingly enforcing requirements through routine inspections. This trend is expected to extend globally, with the China Drug Authority signaling similar actions in major Asian markets.

In response to this changing environment, sponsors are reshaping their approach to disclosure. Centralizing oversight and incorporating automation goes beyond addressing day-to-day issues, creating flexible solutions that offer a strategic advantage. Sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this dynamic and challenging landscape.