The Clinical Trials Transformation Initiative (CTTI) is comprised of more than 80 organizations united by the mission to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. 

The multi-stakeholder member organizations includes representatives from the FDA, big pharma, smaller biotechs, clinical research organizations (CROs), institutional review boards (IRBs), academic institutions participating in clinical research, patient groups, independent patient representatives, and technology companies.

In June, CTTI released “Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials,” which contains recommendations for integrating mobile technology into clinical trials.

We recently spoke with Jennifer Goldsack, CTTI’s Project Manager, about the status of mobile technology adoption in clinical trials, the process behind CTTI’s recommendations, and future projects aimed at overcoming obstacles in endpoint development.

While traditional endpoints and biomarkers are still necessary for FDA submission and regulation, the advent of digital tools has presented the opportunity to revolutionize the data capture method — specifically, the ability to collect more specific, relevant data points or digital biomarkers.

According to Rock Health’s report The Emerging Influence of Digital Biomarkers on Healthcare, digital biomarkers are “consumer-generated physiological and behavioral measures collected through connected digital tools” which “represent an opportunity to capture clinically meaningful, objective data in a cost-effective manner.”

The industries in which sensors and mobile technology have been making the biggest waves are ones where capturing movement, physiological response, and user activity are directly related to monetary outcome — for example, pharmaceuticals, sports and fitness, and healthcare. If a pharmaceutical company can objectively prove that a drug is improving quality of life, or if a doctor can receive an alert when a patient’s heart rate is too fast, that’s a game changing solution.

Jesús Pindado, MC10’s VP of Engineering, shared his thoughts on the role of wearables and digital tools as healthcare evolves, as well as the story and vision behind MC10 for episode 28 of the web series Flow my Friend.

A recent New York Times article explored the cutting-edge beauty and self-care products being developed at L’Oréal’s Technology Incubator.

Partnering with academics and entrepreneurs around the world, the incubator’s Global Vice President Guive Balooch and his 26-person team work together to stay on the forefront of the beauty industry — specifically, “where beauty and technology meet.”

Ecological validity, the quest to create a study atmosphere that best represents a subject’s habitat in order to capture data that reflects natural behavior, is getting a lot easier to achieve thanks to wearable biosensors.

BIOMEDevice, one of New England’s largest medtech events, is coming to Boston this week. We’re excited to hear from speakers innovating the medical device industry, and to share our own vision on stage. Wednesday’s Emerging Sensor Technology Track is packed with sessions forecasting the trajectory of novel sensors in healthcare.

Here are a few that we’re most excited for:

“The Quest for Miniaturized Soft Bioelectronic Devices,” an article published in Nature Biomedical Engineering, opens with the observation that miniaturized, soft bioelectronics are paving the way for advances in health monitoring and care delivery. According to the authors, this opportunity for “intimate coupling of the electronics with tissue” has lead to breakthroughs in both implantable and wearable medical devices, but there is still room for improvement.

We may only be a few months into 2017, but the impact of wearables on healthcare research and clinical trials are already making headlines. Multiple industry publications and clinical journals have been featuring articles highlighting the potential of wearable technology to improve lives and expand our knowledge of human health.

Here are just a few of the studies and partnerships enabled by the impact of wearables on healthcare in 2017.

In an earlier blog, I discussed the value of not limiting data collection sources to the wrist. Though several devices offer wrist-captured physiological signals, this data is limited in scope and not representative of the body’s full spectrum of movement. To highlight this point, we placed BioStampRC Sensors in three locations on a volunteer’s body — the wrist, chest and thigh. Each Sensor captured a distinct accelerometer signal. Once the Sensors were applied, the subject completed a series of activities.

Read on to learn what our experiment demonstrated about the value of multi-location sensing.

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.