By Mukhtar Ahmed, vice president of product strategy, Oracle Health Sciences
In late 2013, the FDA issued its long-awaited final guidance for mobile medical application developers. The agency announced that it will pursue limited regulation of health and wellness applications that help patients manage their conditions. Instead, the FDA will focus efforts, including the application of risk-based standards, on diagnostic and quasi-medical device applications.
The recent ruling provides important clarity for organizations that look to use innovative machine-to-machine (M2M) technologies to significantly improve the efficiency and accuracy of clinical trials — a perennial quest for many health sciences organizations.
Nearly every day we hear of exciting new uses for M2M solutions in the health and fitness realm. For example, M2M technologies are offering new insight into the prevention and treatment of traumatic brain injuries. With nearly 4 million mild traumatic brain injuries reported annually due to sports and recreational activities, the health community is excited at the prospect of using helmet sensors that collect immediate and accurate data on the severity and history of impacts a user experiences. The information enables real-time assessments that can protect the athlete from further potential harm. Another M2M solution is helping healthcare providers assess the severity of concussions, and patient progress after one occurs, with a device and iPad application that tracks a patient’s dynamic vision reflexes, motor skills, balance, and more.
Life sciences organizations are equally eager to embrace emerging M2M technologies, especially in their clinical development programs. M2M solutions have the potential to transform many clinical programs — from patient recruitment and retention, to data collection and accuracy, to safety and pharmacovigilance. The possibilities are exciting and endless.
Accurate And Immediate Data Drives Informed, Productive, And Timely Studies
Health sciences organizations and their CRO partners have long been focused on improving the productivity of clinical trials by boosting data collection and management efficiency. As a result, electronic data capture solutions have become the industry standard. We’ve made much less progress, however, improving the fundamental quality of clinical trial data. This is where M2M technologies will prove their true potential.
M2M technologies enable continuous patient monitoring, which can deliver several important and long-term advantages to research teams. First, researchers can collect more types and higher volumes of data than ever before. Traditional clinical trials typically rely on patient journals and intermittent exams. With M2M sensors and telemetry connectors — whether the patient wears them or digests them — researchers can collect continuous data on patient vitals, medicine intake, activity levels, and more. With these real-time statistics, trial managers can gain key insight into efficacy not possible with traditional trial methods.
Additionally, M2M enables an immediacy of data collection that was previously impossible to achieve, and which can have important implications for clinical trial safety. Solutions can deliver data automatically and instantly, without human intervention, to researchers, who can then identify potential adverse events sooner to improve safety as well as accelerate the overall pace of data collection, all helping to speed time to data lock and regulatory submission.
With any clinical trial or data collection situation, the accuracy and quality of the data is extremely important to the end result of the research. M2M solutions enable trial sponsors to collect higher volumes of information and an expanded array of data types to support more exhaustive analysis and insight. Another benefit of continuous data capture is that the risk of human error with manual data entry is removed.
Overcoming The Challenge Of Protocol Compliance, Medical Adherence, And Patient Engagement
Protocol compliance, medical adherence, and patient engagement remain significant challenges for clinical programs. A study published in the New England Journal of Medicine notes that clinical trials report average adherence rates of only 43 percent to 78 percent among patients receiving treatment for chronic conditions. Another example of protocol adherence challenges comes from a double-blind outpatient study examined by the NIH, in which only 39 percent of patients met 100 percent compliance on all visits.
Low patient engagement can have a detrimental effect on the economics of clinical trials and ultimately the success or failure rate of the trial as a whole, potentially wasting time and money.
Continuous monitoring, made possible through M2M technologies, can enable researchers to confirm treatment adherence with near absolute certainty, which we could not do before. As a result, study sponsors and managers can more accurately determine efficacy as they filter out nonadhering patients.
Continuous monitoring with M2M technology can also facilitate subject recruitment, and help sites optimize their performance by focusing on the science, simplifying unnecessary trial complexities, and ultimately shortening the length of a trial. Trial managers could identify nonadhering patients quickly and make faster decisions about whether to remove them from the study or focus resources on boosting adherence. This capability also provides better insight into how many subjects will be required to complete the trial, and more importantly, it can help reach key decisions concerning the validity of protocol amendments and the progression to latter stages of clinical development.
Further, M2M solutions can help improve participant retention because recording critical data and adherence would be automated and, therefore, 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.
Improving Trial Safety Through Real-Time Decision Making
M2M technologies enable continuous monitoring that can have an immediate positive impact on patient safety. With vast and accurate information streaming in real time, researchers can quickly identify potential adverse events or side effects such as changes to heart rate, heart rhythm, blood pressure, or sleeping patterns, after prescribing a medication or therapy, and they can 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.
We are just beginning to get a glimpse into the exciting real-world potential of M2M technologies in the clinical realm. For example, we are seeing the emergence of surgical instruments equipped with imaging telemetry sensors that support four-dimensional (4D) visualization and predictive simulation modeling. For therapies that have a surgical component, these smart surgical instruments capture and process rich data, which can then be used to build a real-time visual model of the specific patient’s anatomy as the surgeon conducts the procedure. The data from the surgical procedure can provide significant real-time insight and guidance for the surgeon and the operating theater team. This critical physiologic data can also be transmitted to researchers to yield greater insight into outcomes and potential adverse events.
Another example is Proteus Digital Health’s FDA-approved ingestible sensor, designed to work 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 smartphone.
The ingestible sensor sends a signal containing a unique identifier recording 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.
Becoming Early Adopters
Challenges — whether regulatory, technological, or ethical — are to be expected with the maturation and adoption of any revolutionary technology. M2M is no different. However, it is important to note that the challenges are far from insurmountable.
Safety is paramount in the health sciences, and the FDA guidance will help bring structure and process to the development and testing of M2M technologies designed for the medical sector. Security of confidential and protected health information is a constant concern, as are regulatory policies regarding the use of such information technology in medicine. Regulatory policies are being created to not only promote innovation and adoption of technologies such as M2M, but to also protect patient safety and security.
The influx of massive volumes of data emanating from M2M applications can also present a Big Data challenge for study sponsors and their CRO partners. To realize the true potential of M2M technology, and transform clinical trials, organizations must be able to rapidly analyze and act on the vital information gathered in real time.
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 progressing rapidly toward greater use of M2M technologies.