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Mukhtaer Ahmed outlines how advances in machine-to-machine (M2M) technologies have the potential to transform clinical development programs, including clinical trials.
Almost daily, we learn of stunning new advances in machine-to-machine (M2M) technologies in healthcare and life sciences, where sensors collect vast amounts of data that yield immediate and long-term insight, and that carry the promise of improved outcomes and quality of life.
Just this summer, Vanderbilt University amazed us with the introduction of the first bionic leg, which uses M2M technologies to integrate human and machine like never before. We are also seeing the advent of powerful M2M technologies in the surgical realm. For example, inertial microelectromechanical systems (MEMS) sensor technology can determine motion and location and significantly improve accuracy in aligning hip and knee implants with a patient’s anatomy.
M2M technologies also have the potential to transform clinical development programs, including clinical trials. For the last 15 years, health sciences organizations and their contract research organization (CRO) partners have been focused on improving the productivity of clinical trials by boosting data collection and management efficiency. Electronic data capture solutions, after many years, have become the industry standard.
Much less progress, however, has been made in improving the fundamental quality of clinical trial data. This is where M2M technologies have the opportunity to really shine.
More Data + Greater Accuracy = More Productive and Informed Studies
M2M technologies, which enable continuous patient monitoring, capture dynamic data that deliver three important advantages to research teams.
· Variety and Volume – Researchers can collect more types and higher volumes of data than ever before. For example, M2M sensors can collect continuous data on physiologic vitals as well as activity levels and types, which can yield important insight into efficacy not possible with traditional patient journals and periodic exams.
· Immediacy – M2M enables immediate capture of data without human intervention, accelerating delivery of important data and indicators to researchers. This immediacy can help researchers to identify potential adverse events sooner to improve safety as well as accelerate the overall pace of data collection, helping to speed time to data lock and regulatory submission.
· Accuracy – Using M2M solutions, trial sponsors and CROs can improve data quality and accuracy in two important ways. First, the ability to collect higher volumes of information and an expanded array of data types from trial participants supports more thorough analysis and more informed insight. As important, automated data capture removes the risks of errors associated with manual data entry.
Improving Visibility into Protocol Adherence
M2M technologies show important promise in validating and improving protocol adherence – an area that continues to challenge clinical trial sponsors and managers. A New England Journal of Medicine report cites that clinical trials report average adherence rates of only 43 percent to 78 percentamong patients receiving treatment for chronic conditions. These numbers can have a powerful impact on the economics and accuracy of clinical trials. For example, just a 20% decrease in medication adherence may result in the need for a greater than 50 percent increase in sample size in order to maintain equivalent power.
Continuous monitoring, made possible through M2M technologies, can enable researchers to confirm treatment adherence with near absolute certainty, which we cannot do today. As a result, study sponsors and managers could more accurately determine efficacy as they can filter out non-adhering patients. In addition, continuous monitoring with M2M technology can facilitate subject recruitment and, ultimately, shorten the length of a trial. If a participant is not adhering, trial managers could drop them quickly or focus resources on boosting adherence, yielding earlier insight into how many subjects will be required to complete the trial.
Further, M2M solutions can help to improve participant retention as recording critical data and adherence will be more convenient. In addition, the ability to automatically upload data to the clinical data management system would eliminate manual input into an electronic case report form – driving new levels of study efficiency.
Real-Time Decision Making
There is an important link between M2M-enabled continuous monitoring and improved safety. With vast and accurate information streaming in real time, researchers can more quickly identify potential adverse events or side effects, such as changes to heart rate, heart rhythm, blood pressure or sleeping patterns, after taking a medication or therapy, and take action to intercede. This capability also has promising application in post-market surveillance.
As important, access to real-time information can support adaptive trials, providing early indications of changes that might need to be made to protocol, sample size or trial scope. Similarly, trial sponsors can have earlier insight into a therapy that is performing better than expected, which would accelerate the delivery of life-saving treatments to market.
M2M at Work
M2M technologies are beginning to show their powerful potential for improving adherence in clinical trials and for post-marketing surveillance. For example, Proteus Digital Health provides an FDA-approved ingestible sensor that works together with a wearable sensor to capture precise information about medication ingestion, dose timing, physiologic responses and other behaviors, sending the digital health information to a patient’s smart phone.
The ingestible sensor sends a signal containing a unique identifier allowing recording of the time the patient took a pill. A wearable sensor worn on the skin captures continuous readings of the patient’s heart rate, temperature, activity and rest patterns. The solution can collect more than 5,000 data points per minute.
Another use of M2M technology applicable to improving data quality in clinical trials is the emergence of surgical instruments equipped with sensors that support 4D visualization and simulation modeling. For therapies that have a surgical component, the ability of surgical instruments to capture rich data, which can be used to build a visual model of the surgery site as well as transmit critical physiologic data to researchers, can yield greater insight into outcomes and potential adverse events.
Accelerating the Adoption Curve
The industry is just beginning its M2M journey, and as with any new technology, challenges arise. Security is an ongoing concern, as it must be when dealing with protected health information.
Additionally, regulatory policies around the use of telemetry and M2M technologies in medicine are still taking shape and must strike a balance between promoting innovation and protecting patient safety.
The influx of massive volumes of data emanating from M2M applications also presents a big data challenge for study sponsors and their CRO partners. To realize the true potential of M2M technology to transform clinical trials, organizations must be able to rapidly analyze and act on the vital information gathered in real time.
These concerns, while valid, will not halt innovation. We are already seeing some progress on the regulatory front. In September 2013, the FDA published its medical app guidance, “promising limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps.”
Forward-looking health sciences organizations can position themselves to rapidly reap the benefits of M2M by building a foundation for adoption in the short term. Many of the core technologies — including data repositories, analytics and integration technologies — are already in place at health sciences organizations today, and we can learn a lot from other industries that are progressing rapidly using M2M technologies.
M2M technologies are poised to transform the way that the industry captures clinical trial data. More important, they have the potential to accelerate the momentum of discovery by enabling new levels of insight, productivity and efficiency across the clinical development continuum.
About the author
Mukhtar Ahmed is Vice President, Product Strategy, Oracle Health Sciences.
 Osterberg L., Blaschke T., “Adherence to Medication,” New England Journal of Medicine, 2005; 353:487-97.
 Pledger, G.W. “Compliance in Clinical Trials: Impact on Design, Analysis, and Interpretation,” Compliance in Epilepsy, Elsevier, 1988.