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Clinical Trials and the Growing Importance of Informatics

Demonstrating the efficacy, safety and differential benefit of a new drug relies on collecting and analyzing enormous amounts of data generated in a clinical trial. Yet this process of extracting knowledge from data is often the source of many inefficiencies.

We recently spoke with Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance to hear his thoughts on how informatics has affected drug development and will continue to transform the pharmaceutical industry.

Q: Why is informatics important in a global context?

More and more major businesses and industries are being run on software and delivered as online services―from movies to agriculture to national defense. Many of the winners of this new economy are Silicon Valley-style technology companies that are invading and overturning established industry structures.

Even in aspects of our daily lives, the dramatic impact of data and software is evident. As Marc Andreessen, the famed software engineer and Silicon Valley entrepreneur, argued in a 2011 WSJ article “Why Software Is Eating the World,” software and online services are disrupting every aspect of our global economy.

I believe drug development will follow a similarly predictable path. “Peopleware” will be increasingly replaced by software and much of the cost and inefficiency of the current model will be eliminated through more widespread adoption of digital technologies.

Q: How does informatics support the conduct of efficient clinical trials?

I think of informatics as the art and science of extracting insights from data. Similarly, this is the ultimate goal of every rigorous and highly controlled clinical trial. From improved data collection through mobile devices and biosensors to enhanced patient recruitment, engagement and outreach through social media, along with more widespread use of genomic data for personalized therapies and improved assessment and mitigation of risk, informatics can and will play a large role in clinical trials.

The pharmaceutical industry, which has been stubbornly recalcitrant to digital transformation, is about to be disrupted in a profound and irreversible way.

Q: What role can informatics play in data management, analysis and integration in a clinical trial?

Often, clinical data is collected in a variety of ways via a multitude of systems that are not designed to work with each other. The same type of activity, such as data cleansing and reconciliation, requires separate and duplicative processes, which introduce unnecessary risk, cost and complexity. Worse still, the data is not standardized from one trial to another, making it impossible to aggregate and compare it across multiple trials, phases and/or compounds.

Informatics-based technologies can integrate all the disparate data collected during the course of a clinical trial, detect and correct critical errors in that data, standardize it to conform to established data standards and deliver it to clinical teams in a way that allows them to make informed decisions.

Our industry needs an effective clinical data integration platform that can integrate, standardize and aggregate data collected from any conceivable source system in real time along with the “apps” that bring this data to life and make it usable by people who don’t have advanced computer skills.

Q: How is informatics currently being employed to improve clinical trial performance?

At Covance, we recognized that the model for clinical development must change. We developed the Xcellerate® Informatics Suite, a technology solution to transform clinical trial conduct by optimizing enrollment, integrating and delivering near real-time data and facilitating collaboration between teams for more efficient trial management.

For example, Xcellerate Trial Design gathers data from more than 40% of global clinical trial investigator performance data and taps into de-identified health information with over 70 million patients. This information allows us and our sponsors to assess the impact of laboratory inclusion and exclusion criteria, identify pockets of potential eligible de-identified patients, their primary care physicians and centers, enabling the efficient design and effective execution of our clinical trials.

Xcellerate Trial Management integrates all critical trial data to keep sponsors up to speed on enrollment results and trial execution in near real time for informed decision making. Another solution within our Informatics Suite, Xcellerate Insights, enables an integrated view of all relevant operational metrics through a single-entry portal to facilitate secure collaboration between Covance and sponsor project teams.

Q: What role does informatics play in greater clinical trial safety?  

While informatics can help optimize the planning and execution of clinical trials, we can also leverage clinical trial data to ensure data quality, patient safety and protocol compliance. Part of our Xcellerate Informatics Suite includes Xcellerate® Monitoring, a tool designed to centralize and integrate all clinical trial data.

Supported by efficient and intuitive workflows, users can view advanced analytics, browse holistic performance data and proactively mitigate trial risks—before they become crises. With several companies already running Xcellerate Monitoring, it’s been very exciting to witness how informatics is optimizing performance in clinical trials.

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