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 transportation 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. 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 very significant role in clinical trials.
The pharmaceutical industry, which traditionally 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?
Covance has recognized that one of the main factors driving the inefficiencies in the current clinical development model is lack of convenient and integrated access to data. Clinical data is usually 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, requires separate and duplicative processes, which introduce unnecessary risk, cost and complexity. Furthermore, the data is rarely integrated while the trial is ongoing, making it difficult to look at systematic errors or trends. And to make matters worse, 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 standardize and aggregate data collected from any conceivable source system in near-real-time along with the “killer 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 platform, 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 Forecasting & Site Selection harnesses proprietary historical performance data from more than 40% of global clinical trial investigators as well as de-identified longitudinal diagnostic data for over 75 million patients, to help us optimize the design of clinical trials. This information allows us and our sponsors to address questions such as: whether it is feasible to recruit patients to the current study design; how to optimize site networks based on historical performance data and available patient populations; how to be more precise and confident about country allocation; how to optimize the inclusion and exclusion criteria; and how to predict enrollment based on epidemiology and prevalence at a specific location.
Our Xcellerate Trial Management suite integrates core operational systems and provides platform connectivity to ensure frictionless execution of clinical studies. Our Xcellerate Insights suite provides integrated, up-to-date views of all relevant operational metrics through a single portal to facilitate information exchange and secure collaboration between Covance and sponsor project teams. Finally, our Xcellerate Monitoring suite provides a uniquely powerful and comprehensive toolset to monitor data quality, patient safety and protocol compliance, identify poorly performing investigational sites, predict potential issues and mitigate areas of risk while the trial is ongoing.
Q: What role does informatics play in increasing patient safety?
One of the unique capabilities of our Xcellerate Monitoring solution is the ability to look at all patient data in a timely, intuitive and comprehensive manner. Our platform offers a wealth of interactive visualization and data analysis options specifically tailored to clinical and safety teams, enables easy detection of emerging safety trends and outliers, supports review, query and resolution workflows, generates automatic alerts and notifications, and offers a wealth of other capabilities for collaborative clinical data review. By enabling rapid identification, escalation, and remediation of findings, our system increases the robustness and quality of clinical trial execution, improves the reliability of investigational data, safeguards subject safety, and ensures adherence to GCP and ethical standards.
Xcellerate Monitoring is being utilized by several companies to improve clinical oversight, and it has been very gratifying to witness its impact and the interest it has generated in the industry. It truly is a remarkable platform.
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.