Today the clinical trial, tomorrow the world
Photo credit: Sanofi Pasteur/Creative Commons
The pharma industry is quickly learning that the clinical trial may no longer be the end of drug development, and how their medicines perform outside of those controlled environments is becoming an important piece of R&D.
Real-world data is expected to help drugmakers design better clinical trials, discover adverse events before regulators do and potentially identify unmet patient needs. As a result, an increasing number of pharma services and technology businesses are making deals and forming partnerships to capitalize on what they see as a clear value proposition to the life sciences industry.
IBM announced Thursday that it partnered with clinical research organization Icon to analyze 50 million de-identified patient records—using IBM's recently acquired big data firm Explorys—to help drugmakers quickly match patients to relevant clinical trials.
“Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30% of total study costs,” Steve Cutler, Icon's COO, said in a release.
IBM Healthcare general manager Sean Hogan also noted in the release, “Through cognitive computing and cloud-based data, our goal is to help our client accelerate the time it takes to complete clinical trials and reach conclusive trial results.”
Kantar Health, too, is investing in real-world analytics, announcing a deal with Data2Life in August. The Tel Aviv–based start-up scrapes data from regulatory bodies like the FDA, the European Medicines Agency and Health Canada along with anonymized information from electronic health records and social media.
“Each data source has its pros and cons, and its own biases,” explained Jeremy Brody, Kantar Health's EVP of corporate partnership. “The idea is to take multiple data sources and to triangulate them to pick up true safety signals.
“It's recognized that clinical trials are not representative of what's going on in the real world,” he added “Drugmakers need to continue to prove the safety of their product.”
Studies conducted by Kantar suggest that data-scraping can alert drugmakers to safety issues three years before the companies would receive a warning from the FDA. Kantar has also said that better use of drug data can help strengthen safety practices and help companies respond to regulatory inquiries.
“It's critical to understand adverse events as soon as possible for patient safety, and from a business perspective to get ahead of the issue and to identify the signal as early as possible,” Brody said.
While the safety benefit may be clearly understood, real-world data also has the potential to inform the parameters, or endpoints, of future clinical trials, says Dr. Henrik Sørensen, who leads the pharmacoepidemiology department at Aarhus University in Denmark.
"Many companies now realize that they can identify a large population [using real-word data] that benefits from their drug and who have not been treated in the past,” he said, adding that the availability of large and compete data sets through Denmark's free health system also helps lower the costs of clinical trials. “We are able to conduct clinical trials for low costs, because we can detect end points from registries and databases.”
The use of patient registries and clinical databases to track how a drug performs is common in Denmark. The US, however, lacks those broader data sets due to its decentralized health system. “We can follow [patients] forever, because we have a tax-supported free healthcare system,” Sørensen said. “In the US, you often use insurance data and people are deidentified and they can go in and out of their health plan.”