By Neil de Crescenzo
June 5, 2013 | Guest Commentary | The life sciences industry has been focused on improving clinical trial productivity in recent years, realizing significant data management efficiency gains over the last decade largely due to the widespread adoption of remote data capture technologies. However, we still have substantial opportunities to further reduce the cost and improve the speed and quality of data collected during clinical trials. The rapid emergence of machine-to-machine (M2M) technologies can transform how we collect clinical trial data and dramatically improve its accuracy and immediacy.
The M2M model uses wired or wireless connectivity to exchange information between web-connected devices without the need for human intervention. In a clinical trial setting, these new technologies open the exciting possibility of continuous, remote patient monitoring, which will not only further accelerate data collection but will vastly improve the quality of patient information collected.
Improve Visibility into Protocol Adherence and Safety
M2M technologies offer new potential for validating and improving protocol adherence—an area that continues to challenge clinical trial sponsors and managers. 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. There is also a link to improved safety as trial sponsors could quickly identify potential adverse events or side effects, such as changes to heart rate or rhythm, blood pressure, or sleeping patterns, after taking a medication or therapy.
In addition, continuous monitoring can facilitate subject recruitment and, ultimately, shorten the length of a trial. If a participant is not adhering, trial managers could drop them quickly, yielding earlier insight into how many subjects will be required to complete the trial. Continuous monitoring can also help to improve participant retention as recording critical data and adherence will be more convenient. Further, 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.
New Technologies Can Impact Medication Adherence
Medication adherence remains a significant opportunity for the industry. According to Prescriptions for a Healthy America, nearly two-thirds of patients (64%) who take medication do not properly adhere to prescription regimens. One-third of chronically ill patients failed to do so at least once in the last month. And poor adherence has real impacts on patient health. Nearly nine out of 10 patients who adhere to their prescription medications describe their health as "good" or "excellent," while only 65% of patients with poor adherence report the same. According to the Wall Street Journal, the New England Healthcare Institute estimates that some $290 billion in costs is wasted each year on unnecessary hospital and doctor visits by people who failed to comply with their medication schedule.
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 smartphone.
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.
Oracle recently announced an exclusive agreement to work with Proteus to provide clinical investigators worldwide with the ability to measure medication ingestion and responses for patients enrolled in clinical trials. The two companies are expected to integrate Proteus’ sensor technology with Oracle’s cloud-based clinical trial management solutions. Combined, this technology will enable pharmas to measure adherence and response in trial settings and to identify a dosing regimen for recommended use. This is one of the most difficult tasks in pharmaceutical development and has significant therapeutic, safety and economic consequences.
Prepare Today for Tomorrow
The industry is just beginning its M2M journey. While some hurdles remain, such as regulatory frameworks and standards adoption, the future is promising for applying these technologies to enable continuous remote monitoring that improves clinical trial data quality and immediacy.
Life sciences organizations can begin to build 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.
One of the greatest challenges that organizations face is the ability to access, receive, store, and manage the exponential increase in data that M2M devices will capture and transmit to their data centers or an infrastructure like the Oracle Health Sciences Cloud. Even more important is the ability to quickly and effectively analyze and act on this information.
This is an exciting time to be part of the health sciences industry, as we see discovery progressing at an unprecedented pace. M2M technologies are poised to sustain and even strengthen this momentum as they begin to drive new levels of insight, productivity and efficiency into the clinical development process and into the more effective utilization of these treatments to improve patients’ health.
Neil de Crescenzo is Senior Vice President and General Manager, Oracle Health Sciences.