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insights LIFESCIENCELEADER.COM MARCH 2014 54 he recent ruling provides important clarity for organi- zations that look to use inno- vative 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 rec- reational activities, the health communi- ty is excited at the prospect of using hel- met sensors that collect immediate and accurate data on the severity and his- tory of impacts a user experiences. The information enables real-time assess- ments 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 technol- ogies, especially in their clinical develop- CLINICAL TRIALS 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 imme- diacy of data collection that was previ- ously impossible to achieve, and which can have important implications for clinical trial safety. Solutions can deliver data automatically and instantly, with- out human intervention, to researchers, who can then identify potential adverse events sooner to improve safety as well as accelerate the overall pace of data col- lection, 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 expand- ed 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 ment programs. M2M solutions have the potential to transform many clinical pro- grams — from patient recruitment and retention, to data collection and accu- racy, 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 tri- als by boosting data collection and man- agement 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 advan- tages to research teams. First, research- ers can collect more types and high- er 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, Embracing M2M Technologies To Transform Clinical Trials M U K H T A R A H M E D 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. T By M. Ahmed EMBRACING M2M TECHNOLOGIES TO TRANSFORM CLINICAL TRIALS 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 1 0314_Clinical_Trial_Oracle.indd 1 2 / 1 9 / 2 0 1 4 2 : 4 3 : 3 0 P M 2/19/2014 2:43:30 PM