Biometric data monitoring

The Latest on the FDA’s Push to Use Mobile Tech to Transform Clinical Trials

The Clinical Trials Transformation Initiative (CTTI) was created by the U.S. FDA in 2007 with Duke University to solve “a crisis for U.S. clinical research”: Studies took too long to start, not enough patients or investigators were participating, and costs were going up. Today, more than 80 organizations are part of the CTTI, representing government, industry, patient, physician and academia.

Recently, the CTTI unveiled recommendations for the use of mobile technology to improve the quality and efficiency of trials. In mid-July we met at the FDA’s offices in Maryland to discuss them, sharing best practices for how to choose the best technologies, design a protocol, and then capture, manage, and prepare data for the FDA’s review.

I found the meeting incredibly refreshing, because it reinforced the FDA’s position of encouraging innovation from all stakeholders: patients, the pharma industry and its technology partners, as well as academia.

The FDA is proactively engaging industry to find new and better ways to capture functional measurements that matter more to patients. I hear this commitment regularly in the discussions that our partners have with the agency, and I heard it again here.  

The project did a great job of balancing both the strategic and mundane, yet important aspects of how mobile technologies can appropriately improve drug development. It’s exciting to consider the ways in which technology can support more patient centric measures and faster efficacy read-outs. At the same time, the data management, infrastructure and validation challenges presented by these tools must be dealt with in way that continues to improve the integrity of the clinical trial process.

The most important message – one I want to help spread – came from Jennifer Goldsack, who helped open the meeting. You can see one of her slides below. 

She reminded us that our job is to  show as much courage as the patients in these studies do. They’re bravely taking chances in search of medical breakthroughs. We have no excuse not to do the same.

By Chris Benko, CEO, Koneksa Health

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Prioritizing the Front Line of Clinic Research

Prioritizing the Front Line of Clinic Research

I am fortunate to have the opportunity to travel to multiple site initiation visits and trainings for clinical research studies each year.  Meeting with the incredibly dedicated study teams is an invaluable experience as I am able to hear from the people who support the front line of clinical research.  During a recent training, I sat down with a research coordinator who seemed to be stretched very thin.  Noticing this, we took a step back to talk through her hesitations.

ActiGraph Launches CentrePoint Toolkit to Provide Technology Framework for Home-­ based Healthcare Solutions

ActiGraph Launches CentrePoint Toolkit to Provide Technology Framework for Home-­ based Healthcare Solutions

Pensacola, FL – Nov 15, 2016 -­ ActiGraph, a leading provider of clinical-­grade wearable activity and sleep monitoring solutions, has announced the launch of the CentrePoint technology toolkit, which enables clients to leverage the company’s ecosystem of hardware and software tools in the development of proprietary remote patient monitoring (RPM) systems and other home healthcare delivery solutions.

What’s the sweet spot for digital health collaborations with pharma clinical studies?

What’s the sweet spot for digital health collaborations with pharma clinical studies?

This week’s news that Takeda Pharmaceuticals inked a deal with Koneksa Health, a digital health startup that uses wearables and connected devices to gather patient data, reinforces the point that pharma companies have found a place for digital health tools in drug development. Koneksa Health CEO Chris Benko said he views the natural place for the use of these technologies in clinical studies either in early phases or as an exploratory addition in later phases in a phone interview with MedCity News.

Patient-Centered Approach to Clinical Trials

Patient-Centered Approach to Clinical Trials

There is an exciting paradigm shift happening in industry sponsored clinical trials, particularly for the patients contributing to research. Prior to joining Koneksa I worked for one of the highest enrolling clinical ophthalmology sites in the country, where over 25 studies were conducted at a time. I’ve experienced first-hand the significant burden placed on participants in clinical trials, with study visits lasting well over six hours.

Innovations Announced at CES

Innovations Announced at CES

 We weren’t able to make it to CES this year, but we were keeping a close eye on the new digital health announcements to see if anything really impressed us.  Amongst many new wearables and sensors that seemed to bring marginal improvement, there were a few hardware / software announcements that we are looking forward to testing and bringing to our customers. 

Breaking Down a Gold Standard

Breaking Down a Gold Standard

One of the common challenges we see at Koneksa is the tendency of the research community to gravitate toward evaluating novel measures or endpoints for concurrence with older and very limited ‘gold standards.’ Previously I discussed the lack of an underlying conceptual framework for activity measures that rely on patient reported outcomes (PROs).  However similar challenges also emerge with more objective performance measures.