Eric Hodgins, senior vice president, research and development technology solutions at QuintilesIMS, told us there are a number of dynamics “significantly transforming the industry and driving an increase in technology-enabled clinical research.”
Adam Butler, senior vice president, strategic development and corporate marketing at Bracket, also cited recent encouragement from regulators.
“Regulators have started to embrace and encourage this development, and this is probably the most significant shift that has facilitated adoption amongst pharma and biotech,” he told us.
A new era
According to Hodgins, scientific breakthroughs have allowed the industry to access new compounds and resources that have changed the types of molecules developed and the way in which clinical trials are executed.
For example, he cited the industry’s entrance into the new era of precision medicine in which companies are developing therapies based on a patient’s unique genetic sequence.
Concurrently, technology is rapidly evolving and bringing new levels of data storage capacity, computing power, and connectivity levels – “unlike anything we have ever seen,” said Hodgins
“We now live in a world where my telephone can talk to my refrigerator and thermostat,” he added.
Echoing Hodgins sentiment, Butler commented, “It’s an exciting time to see so much development happening so quickly – in an area that has traditionally suffered from a lack of innovation.”
So what do these technological advancements mean for clinical research?
“All of the stakeholders in clinical research are aware of the need for new and better tools to help us conduct clinical trials,” Butler told us.
Patient engagement and site adoption are two obstacles already addressed with new technologies, as seen with the rise in clinical grade wearables, smartphone applications, computer vision, and cloud computing, among others.
Hodgins explained that recent advancement translates to new opportunities to apply technology intelligently to analytics, automation, and machine learning, which improve clinical trial execution and the patient experience.
“Patient engagement in research is essential, and many of these new technologies are predicated on patient interfaces,” added Butler. “Companies that understand those interfaces, and build with a patient's and a clinician's voice, will succeed.”
Differentiation and value
According to Hodgins, the companies that thrive will be those that harness the power of their data and manage it efficiently.
“Over the last 25 years, our industry has largely operated in vertical silos; data management, clinical research, lab research and other elements have been managed separately,” he explained.
In the upcoming years, Hodgins said the first step to differentiation will be for companies to learn to think horizontally, “by holistically integrating their data across all those functions using automation and workflow processes.”
“Companies that distinguish themselves in this new era will be ones that understand the specific problem they want to solve with their data and then apply the rich therapeutic and domain expertise required to extract meaningful insights,” he said.
Butler added that developing patient-centric tools is the “clearest path” to differentiation.
The future of technology-enabled research
“All the rules are about to change,” said Hodgins – and as such, companies are going to have to rethink how they have done things over the past 30 years.
“The industry players involved in clinical research cannot afford to ignore the evolution of science and technology in terms of how clinical trials are now going to be conducted,” Hodgins added.
With increasing pressure from both patients and regulators, the industry must use these new resources to bring new medicines to patients faster while ensuring quality, safety and patient privacy. “It is incumbent on us,” Hodgins said.
However, the industry will face challenges with regulators, who, Hodgins said, struggle to keep regulations in accord with scientific and technological advances.
“Companies are going to have to disrupt the industry with new approaches and partner with regulatory agencies such as the Food and Drug Administration (FDA) to provide guidance on new regulations,” he said. “The future of technology-enabled clinical research will ultimately be about companies continuing to intelligently leverage technology within the existing regulatory framework and, in parallel, taking the next leap to disrupt the industry with innovation.”