Imagine being able to conduct a trial without opening any sites, or using virtual reality to educate patients using 3D visuals. And what if you could confidently share all of that detailed patient data via digital networks, knowing it would be protected from hackers?
These are all real life technology solutions that are already being used and will define the next generation of clinical research.
Advances in analytics are already enabling improved decision-making across all aspects of the drug development process. These tools are helping us to improve recruiting through better site selection, and give us the added ability to proactively identify patient populations who match inclusion/exclusion criteria. Better data is also helping developers avoid costly protocol amendments—which can add more than $500,000 and three months to a trial.
Investigators are also adopting specialized apps and software systems to streamline patient monitoring and automate completion of consent forms. These tools are also adding benefits for research staff, who can use digital tools to support workforce mobility, and real time risk-based monitoring to reduce the workload of busy CRAs. These advances are delivering measurable time and cost savings while improving our ability to identify and address safety issues more proactively. And, we’ve only just scratched the surface of what these tools can do.
Going forward, we expect continued adoption of advanced technologies including connected monitoring devices to track patients, and the use of telemedicine to oversee patients remotely. That means investigators can reach more patients over a larger geography with less disruption to their lives.
We’ve already seen the benefits of monitoring devices in many settings, including diabetes trials, where continuous glucose monitors provide a real-time stream of data about patients’ glucose levels via wireless radio frequency devices. These devices give investigators more data in less time with fewer doctor visits, which shortens trial duration and improves retention—all of which cuts costs and improves results.
Our research will be further supported by the evolution of big data tools to capture and analyze precise genetic information, and immersive technologies. These will include virtual and augmented reality to educate patients, and create engagement opportunities beyond the face-to-face physician experience.
Technology applied: virtual trials
We are seeing an evolution where these new tools are now coming together to enable “site-less” trials – where studies are conducted virtually using telemedicine technology, patient monitoring devices, and a handful of centrally located investigators who keep track of thousands of patients via their local physicians.
We tested this telemedicine concept in 2016 in a trial of Alzheimer’s disease patients in Arizona, where we recruited roughly 15,000 patients through 13 primary care sites, who were monitored by their own physicians under the guidance of two neurology experts. The model allowed us to complete recruiting three times faster than in a conventional study, and a review of results showed excellent correlation between in-person tested and assessments conducted via tele-monitoring, proving the quality of data was the same in both scenarios. The details of that study were presented by IQVIA’s Penny Randall, MD, MBA in a session at DIA 2017 entitled Are We Ready for Telemedicine-Powered Clinical Trials?
Most importantly, all of this digital data will be uniformly protected via block chain technology, which was originally created to protect digital currency transactions, but has huge potential to address the interoperability issues in health IT systems. Blockchain will soon allow patients, physicians, and investigators to securely share electronic health data, with the confidence that the data will not be hacked.
As we perfect these technologies and their application in clinical research we can overcome many of the obstacles we face today, particularly in rare disease research, where patients are scattered across regions, and sites may only host a handful of participants at any given time.
All of these technology advances -- including the ability to conduct trials virtually – have the potential to transform the research landscape, allowing us to conduct better, faster and more efficient trials, while providing greater access to patients and data about their care.