As value-based health care, personalized medicine and patient-centricity continue to drive transformation around how health care is paid for and delivered, connectivity between people, devices and environments is crucial. The Internet of Medical Things (IoMT) is a major enabling force driving this connectivity in health care and life sciences.
In clinical research, devices, sensors and other IoMT technologies are playing a critical role in transforming clinical trials and the drugs and therapies themselves. And, the best outcomes of this shift are better patient experiences and more effective therapies.
Technology fueling the adoption of decentralized trials
In January 2019, FDA Commissioner Dr. Scott Gottlieb said the following about the evolution of clinical trials:
“Pragmatic and hybrid clinical trials, including decentralized trials that are conducted at the point of care – and that incorporate real world evidence – can help clinical trials become more agile and efficient by reducing administrative burdens on sponsors and those conducting trials, and can allow patients to receive treatments from community providers without compromising the quality of the trial or the integrity of the data that’s being collected.”
Gottlieb gave this speech a full year before the coronavirus pandemic, yet his assessment of the importance of new research approaches foreshadows what actually took place when the industry was forced to quickly adapt to keep ongoing clinical trials on track and spin up new trials around diagnostics, treatments and vaccines in the face of the COVID-19 pandemic.
Decentralized trials is a catch-all term for any clinical research approach that uses technology to make traditional site-based trials more efficient, safer, and more convenient for patients. In his provocative article for Medium, “Are virtual and remote clinical trials dead?,” Novartis Biome co-founder and Global Head Jacob LaPorte identified the following four future archetypes of clinical research:
- AUGMENTED SITE – where appropriate technologies like telemedicine or mobile nurses and sensors are integrated in the process to reduce the burden of participation.
- LOCAL PROVIDER – where existing community health care infrastructures are converted to research sites to bring the trial closer to patients.
- CENTRAL SITE – where mobile clinicians bring study procedures closer to patients, either in their homes or in another local setting, and technology is used to share data and manage the trial from one central site.
- DIRECT TO PATIENT – where sponsors work directly with patients to conduct the trial.
Moving forward, these four clinical research types will be deployed in various hybrid models to create the best experience for study participants while meeting study objectives. And, the technologies used to support these new methods will become the norm as they’re proven effective and approved by regulatory authorities. Source: What’s Next for Life Sciences e-book, chapter 2 Designing a Better Clinical Trial by Matt Becker
Improving the patient experience
Decentralized clinical trials are ultimately a big win for patient centricity in our industry. Decentralized methods make it easier and safer for patients to participate in clinical research, improve communication to help patients maintain compliance with study protocol, and improve our understanding of how effective and safe new therapies will be in the real world.
Data makes decentralizes trials possible. This includes data from remote monitoring and realworld data. The data makes it possible to deploy decentralized trial models to enroll patients faster, improve patient adherence, make better clinical hypotheses, and develop more targeted medicines.
A closer look at the role of IoMT technology in clinical research.
The evaluation of treatment outcomes has moved beyond the collection of short -term outcomes in clinical trials to include sensors and devices for continuous patient monitoring and data collection. This means that drugs can be approved with more confidence because patients can be monitored both before and after drug approval.
The connectivity between patient monitoring devices and patients’ electronic health care records allows clinical trials to be nested within the regular clinical practice, thereby allowing more comfort for the patient, long-term monitoring, lower costs, and real-world results.
Craig Lipset, advisor, advocate and educator in the area of decentralized clinical trials and the former head of clinical innovation at Pfizer, recently spoke about the concept of clinical research as a care option on an episode of the Health Pulse podcast, The Next Evolution of Clinical Trials. Lipset explains that technology enables new ways for pharma companies to connect with non-investigator physicians to improve engagement with community health care and democratize access to clinical research.
Supporting the next generation of therapies
The next generation of personalized, targeted therapeutics can no longer be developed and marketed using traditional models of clinical development, approval, and reimbursement. The administration of such therapies requires an infrastructure that can support adequate outcome recording and evaluations. The value of these treatments will need to be demonstrated over time and by using outcome-based reimbursement models. New and unique models need to be developed where IoMT plays a central role by enabling the continuous collection and evaluation of outcome measures.
The integration of IoMT in drug development, especially clinical development, requires the standardization of outcomes that are measured so that adequate conclusions can be drawn, and the data collected can be used for multiple purposes. Source: What’s Next for Life Sciences e-book, chapter 5 IoT and Telemedicine in Clinical Research by Mark Wolff and Stijn Rogiers
A promising future for technology enabled clinical research
IoMT technology has the potential to make the drug development process more efficient and more accessible to diverse and representative patient populations worldwide. Data interoperability and robust technological support for investigators and patients will be essential in order to realize this potential.
About SAS in IoT
SAS empowers organizations to create and sustain business value from diverse IoT data and initiatives, whether that data is at the edge, in the cloud, or anywhere in between. Our robust, scalable, and open edge-to-cloud analytics platform delivers deep expertise in advanced analytics – including AI, machine learning, deep learning, and streaming analytics – to help customers reduce risk and boost business performance. Learn more about our industry and technology solutions at www.sas.com/iotsolutions
Cameron McLauchlin, Life Sciences Industry, SAS