Clinical Adjudication: How experience and technology make the difference

An Interview with Perceptive’s Craig McLendon

Clinical trial sponsors are under more pressure than ever to get new treatments to market sooner, without compromising clinical trial data integrity.

This is where clinical adjudication from Perceptive comes in.

Having endpoint data reviewed by an independent adjudication service provider helps sponsors lower the risk of variation in clinical trial outcomes and prevent delays that might otherwise impact their development timelines.

But not all adjudication services are the same. Here we talk with Craig McLendon, Perceptive’s VP of Clinical Adjudication about how the field has advanced over the past few decades and what sponsors should look for in a reliable adjudication partner.

How does clinical adjudication add value to clinical development?

Clinical adjudication is a systematic, blinded, and unbiased way for sponsors to ensure trial endpoints are evaluated consistently. This is especially important in large, multi-country clinical trials with subjective endpoints where regional and/or cultural biases can impact clinical trial results.

An adjudication provider looks at endpoint data from a structured and comprehensive viewpoint, based on pre-established definitions of what constitutes an event. For example, if you present a patient case to ten cardiologists and ask if the patient presented with a heart attack, five may say yes and five may say no. Without a structured definition of constitutes a heart attack and unbiased interpretation of the data behind the event, sponsors might find their studies subject to variances that could delay or even end their development programs.

By working with a reliable clinical adjudication service provider, sponsors gain confidence that all events are reviewed with precision and worry less about biased data causing delays in their regulatory submissions and reviews.

What should trial sponsors look for in a clinical adjudication partner?

The most relevant criterion is a provider’s experience. Sponsors should make sure that experience is not just limited to academic settings, as adjudicating endpoints in the highly regulated pharmaceutical industry requires a higher level of rigor and knowledge to meet regulators’ expectations. And sponsors should look for providers who have direct experience in the therapeutic area they’re studying, as well as relationships with the KOLs who can contribute their expertise to the adjudication process.

In a world where all adjudication providers use advanced technology to streamline their processes, it’s the people and the knowledge they bring to the table that’s going to make a difference when the future of your development program is on the line.

In your 25 years of experiences, what changes / advances have you seen that have had the greatest impact in clinical adjudication?

While the overall adjudication process hasn’t changed much, the introduction of technology has certainly improved our ability to adjudicate events faster, and with more reliability. I remember in the 90’s we used to collect data manually, which resulted in huge reams of paper that had to be moved around, collated, and redacted, which was a lengthy process. With the technological advances we have today, this is all done online which not only saves significant time, but also gives us the benefit of real time collaboration with adjudicators around the world.

Perceptive’s Clinical Adjudication Process

How does Perceptive leverage technology to innovate clinical event adjudication?

We utilize a web-based electronic adjudication system (EAS) that complies with 21 CFR Part 11 standards. This system maintains a comprehensive audit trail of all activities and offers many other features that improve efficiencies in the adjudication workflow, such as direct data uploads from sites, centralized electronic tracking and storage of all event data and adjudication results, and real-time reporting for complete transparency throughout the process.

We’re also leveraging automated intelligence as the next driver of adjudication efficiencies. For example, AI tools are helping us to analyze foreign language documents to identify duplicate content so we don’t waste translation resources on them. And the use cases for AI in adjudication are expanding by the day!