As of February 2017, ClinicalTrials.gov, an online database of clinical studies maintained by the U.S. National Institutes of Health (NIH), lists 239,290 studies with locations in all 50 states and in 197 countries.
In a study evaluating the effectiveness of a drug designed to control heart rate, monitoring a subject’s pulse over a period of time will undoubtedly answer the primary question: Is the drug effective at controlling the patient’s heart rate?
While the answer to that primary question may be yes, researchers must consider what else happened while the patient was being treated with the drug. Perhaps the subject’s heart rate was well controlled, but the subject became more sedentary and less active. Or perhaps the subject experienced increased restlessness during sleep. The heart rate might be controlled, but that doesn’t mean the treatment is successful. Without the surrounding contextual data, comprehension of a subject’s response to treatment is incomplete.
As the U.S. healthcare system becomes increasingly outcomes-based and accountable, evaluating therapeutic efficacy requires researchers to consider the bigger picture of a subject’s health.
Thanks to the advent and implementation of new and constantly developing technologies, healthcare data collection has improved dramatically in the past few decades.
From more than 20 years as an Intensive Care Unit (ICU) Director to serving as a consultant and medical director of several medical product companies, Art Combs, MC10’s Chief Medical Officer, has witnessed firsthand the evolution of the healthcare industry. He has identified five major shifts underlying the change.
Real world evidence, or RWE for short, is the term made famous by the 21st Century Cures Act, a law enacted by the United States Congress in December 2016.
Section 3022 of the bill calls for the FDA to establish a program and framework for evaluating the use of RWE, defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.”
In other words, RWE is health care information gathered outside of a typical clinical trial environment. Instead, the data is collected from “atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.” . To clarify the term, and to provide guidance on the relevance and proper collection of RWE, the FDA has also provided a Use of Real-World Evidence Document.
The push for RWE encourages pharmaceutical companies to collect data about drug usage following FDA approval as well as during actual patient interaction. The benefits of RWE for patients, pharmaceutical companies and the healthcare industry as a whole are significant.
Digital health tools have reached a notable prevalence in research studies and clinical trials. Universities, pharmaceutical companies and medical device manufacturers are transitioning from evaluating these novel data capture tools to seriously incorporating mobile technology in their studies.
The challenge is now to determine the best way to leverage apps and wearables and take advantage of the novel solutions they provide.
On Tuesday, February 7, expert insight into stretchable electronics will kickstart the morning at the 6th annual Wearable Tech + Digital Health + NeuroTech Conference.
The conference, sponsored by ApplySci, will take place at Stanford University. Topics will center on factors driving the health sensor revolution and include predictive health, adaptive medicine, novel sensors, robotics, VR, and machine learning.
Technology (and specifically wearable technology) has become a critical component of the sports industry. And in the past year, the two have continued to strengthen their bond.
We’re excited to announce that MC10 co-founder John Rogers’ latest invention recently landed on the cover of the November 2016 issue of Science Translational Medicine.
Rogers, a pioneer in the field of soft bioelectronics, has created a novel epidermal microfluidic device which harvests and routes tiny droplets of sweat from skin pores for biochemical analysis. Researchers can now tap into rich information stored in sweat, including hormone levels, sodium, chloride, pH and stress indicators. Rogers et al. published their first demonstration of skin-worn epidermal microfluidics in Science Translational Medicine.
It’s no secret that wearables and mobile technology are positioned for growth, but the numerous possible applications make it difficult to foresee what this growth will look like.
In 2016, we saw collaborations, partnerships, novel use cases and explorations. And MC10 is excited to see these new applications and partnerships continue to develop and strengthen in 2017 as wearable technology breaks out from initial concepts and feasibility studies to impact a wider audience and begin to approach its potential.
Not only do over 40 million adults in the U.S. get less than the recommended seven to nine hours of sleep per night, but the quality of sleep they are getting isn’t all that great. According to the National Sleep Foundation’s 2014 Sleep Health Index™, 35 percent of Americans report their sleep quality as either ‘poor’ or ‘only fair’.
Emerging classes of wearable technologies and telehealth systems have recently been deployed in clinical studies (The American Journal of Psychiatry, Health Affairs (1), Health Affairs (2), Telemed J E Health, Pediatric Annals), and have demonstrated the potential to redefine our understanding of disease management in the hospital, and ultimately, home environment.
Here are four reasons that applying emerging wearable technologies and biosensing systems to your research will lead to funding, advancing the goal of building a strong foundation for digital medicine in the 21st century.
One of the biggest challenges researchers face when conducting a study is ensuring subject compliance. Therefore, it is in a researcher's best interest to design clinical trials and research studies that closely mirror and fit into the lives of study subjects, since this will increase the likelihood of subjects complying and adhering to the study protocol.