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insights LIFESCIENCELEADER.COM MARCH 2014 56 CLINICAL TRIALS The ingestible sensor sends a signal containing a unique identifier recording the time the patient took a pill. A wear- able 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, tech- nological, 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 devel- opment 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 medi- cine. Regulatory policies are being cre- ated 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 orga- nizations can position themselves to rapidly reap the benefits of M2M by building a foundation for adoption in the short term. Many of the core tech- nologies — 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 tech- nologies. L 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 stream- ing 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 pat- terns, after prescribing a medication or therapy, and they can take action to inter- cede. 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 TODAY 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 emer- gence of surgical instruments equipped with imaging telemetry sensors that sup- port four-dimensional (4D) visualization and predictive simulation modeling. For therapies that have a surgical compo- nent, 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 poten- tial adverse events. Another example is Proteus Digital Health's FDA-approved ingestible sensor, designed to work together with a wear- able sensor to capture precise informa- tion about medication ingestion, dose timing, physiologic responses, and other behaviors, sending the digital health information to a patient's smartphone. Protocol compliance, medical adherence, and patient engagement remain signifi- cant 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 adher- ence with near absolute certainty, which we could not do before. As a result, study sponsors and managers can more accu- rately 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 adher- ence. 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 deci- sions concerning the validity of protocol amendments and the progression to lat- ter 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 abil- ity 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. By M. Ahmed EMBRACING M2M TECHNOLOGIES TO TRANSFORM CLINICAL TRIALS Mukhtar Ahmed has been the vice president of product strategy for Oracle Health Sciences for more than two years. 0 3 1 4 _ C l i n i c a l _ T r i a l _ O r a c l e . i n d d 2 0314_Clinical_Trial_Oracle.indd 2 2 / 1 9 / 2 0 1 4 2 : 4 3 : 4 1 P M 2/19/2014 2:43:41 PM