New Model for Clinical Trial Conduct
New and somewhat futuristic models for clinical trial conduct are on our doorstep.
Technology is at everyone’s fingertips, and the development of tools that will affect how we collect and manage clinical trial data is an ongoing reality.
A recent conference at the University of California Center for Body Computing (CBC) clearly demonstrated we are in a culture of innovation in this area. Experts said they believe technology is not the problem or the driver of our ever rising healthcare costs, but the solution, and represents the best achievements in society today. The need for digital healthcare products, when their capabilities are fully recognized, will transcend policy and politics.
One example of this progress in the clinical trials arena recently was reported by CenterWatch, regarding the collection of large volumes of objective data that can provide real-time and continuous insight into vital signs, heart rate variability, body posture, fall detection and ECG data thru wearable devices. In a recent collaborative study, Medidata and GlaxoSmithKline have been evaluating outcome data exploring mobile health technology and conducting their own application evaluations. They hope to use this data to provide insights to enable the development of new models for clinical trial conduct that will align sites and patients to provide faster study completion with reduced costs. While there is much work to do before this becomes actionable in live trials, progress is being made to lay the groundwork for such models.
The premise of compliance in clinical trials with the collection of continuous data also could be revolutionized by technology advancing the ease of data collection. Consider there now are more than five billion mobile phone users worldwide, and the vast majority of those individuals are from emerging economies. This global platform alone allows us an opportunity to potentially place a diagnostic- and healthcare-related tool in the hands of almost everyone on earth. In the near future it will be common for consumers to monitor their every heart beat and vital sign, making the evolution of data collection for clinical trials a natural extension of such activities of daily living.
This technology is putting patients at the center of clinical research, which many might say is where they belong. Consider the fact that mobile device-driven data collection allows patients to report data-rich information without even thinking about it. The days of a hand-held device or a hard-copy diary will soon be in the past. The technology already exists for much of a mobile-driven clinical trial. Fast developing ePRO systems already allow patients to self-report data. This data management also allows for better integration of eclinical systems to distribute data more quickly to clinical teams. This process might, in some cases, allow for faster reporting of adverse events.
According to an online white paper from Datatrak, for the clinical trial industry the rapid growth of low-cost wearable health monitors for the consumer market also will present a fantastic opportunity for identifying potential patients and gathering huge volumes of data spanning years of an individual’s life. The challenge will be regulating the safe boundaries and data blinding implications of potentially millions of data points for harvesting.
As investigators, we must ask ourselves if we are prepared for this revolutionary change and if we have considered how we will evolve to train staff, inform patients and potentially move into an environment of change that allows both more speed and new systems to regulate this form of data collection. Will each device require a regulatory approval process? How will confidentiality of data be monitored and protected?
The trend is upon us, and it would be prudent, at a minimum, to become more knowledgeable about this field. Every company must analyze how mobile applications, social media, cloud storage and Big Data will change its business. The explosive growth in these areas will, most definitely, have a dramatic impact on clinical research sites.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to firstname.lastname@example.org.
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