Can You Comply Your Way to Greatness?

Can You Comply Your Way to Greatness?

An article by Sarah Lyons – Senior Director, Operations

I recently heard something that stuck with me:

“Nobody complies their way to greatness.”

An interesting comment, and a relevant one for all of us in the clinical trial transparency domain. But is there truth to it? Let’s take a closer look at what’s behind that statement.

The changing face of transparency compliance

Compliance is important, and the first step for many transparency programs needing to satisfy EMA Policy 0070 and new Health Canada guidance.

Transparency compliance, however, is not easy—as regulations continue to change, and tight deadlines create new demands for speed and scale. As Health Canada drives short turn-around deadlines and the EMA is poised to re-open, ensuring the capacity and capability to comply will remain front of mind.

But beyond meeting compliance obligations reliably, what can lead a transparency program to greatness?

Greater transparency builds trust and adds value

Beyond compliance, discretionary data sharing for research communities builds a transparent and trusting reputation, which contributes to brand-related outcomes like patient recruitment.

Even beyond transparency, there is great potential for anonymized trial data internally—as pharmaceutical companies look to innovate drug development. This means the same capabilities needed to meet regulatory requirements can be applied to other data sharing and uses, delivering high value to the enterprise.

Compliance is the starting point, but the realized value can be multi-fold.

Increasing value through anonymization

As an example, advancements in artificial intelligence and data science create new opportunities to innovate and differentiate drug development. Anonymization can unlock the value of clinical study data for internal analysis, research and innovation, with potentially high rewards for the enterprise.

A risk-based anonymization methodology preserves the utility of your data based on the context of use, delivering rich data for internal innovation. Because the same methodology and capability can be leveraged across a range of internal uses and external disclosures—regulatory, discretionary and strategic—Clinical Trial Transparency teams have an opportunity to deliver greater value to the enterprise.

Maximize ROI from your anonymization capability

Even if your focus is on compliance, the return on investment for a transparency program can be much greater if the same anonymization capabilities are leveraged to drive internal and external data sharing.

The risk-based, quantitative anonymization methodology promoted by EMA and Health Canada is consistent with emerging standards for anonymization around the world.  For example, a statistically defensible approach to de-identifying information is needed to achieve a level of anonymity under the General Data Protection Regulation (GDPR) and other regulations, such as the recent California Consumer Privacy Act (CCPA).

By getting ahead of the transparency curve, moving from redaction to anonymization, there is potential for economies of scale.

Share and innovate your way to greatness

Your takeaway? Consider external data sharing and internal innovation, such as those led by real-world evidence teams, when establishing your transparency delivery model and modelling your ROI.  Position your transparency team and function as a strategic corporate asset, bringing additional value to the enterprise.

Compliance can lead to greatness—with the right vision and follow-through.

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