Biopharma companies are in desperate need of technologies and strategies that can reduce the cost of their clinical trial programs, which now routinely exceed $1 billion for a new drug. At the same time, these companies face pressure to expand the endpoints measured in their trials in order to demonstrate clinical relevance, economics, and patient satisfaction, all of which are now seen as prerequisites for broad adoption.
Digital health technologies have been mentioned as one solution to this challenge. As the buzz continues to build around mobile health and remote patient monitoring, the idea of using these technologies in clinical trials has gotten more and more attention based on the idea that they could enable a less expensive, more flexible trial model while also expanding the set of data points and the quantity of data that a trial can generate.
But for all the talk about the promise of remote monitoring in drug development, activity has been limited to date. Drug companies are understandably cautious when pondering major changes to an activity that is so critical to their business models and to the health of patients. But many companies are quietly exploring these ideas, and a handful of companies have recently disclosed initiatives in this space:
- Last Fall, GSK partnered with Medidata and Vital Connect to do a proof of concept study on remote monitoring in trials
- Late last year, Biogen gave out 250 FitBit wearable fitness monitors to multiple sclerosis patients to gather data on their activity levels and sleep patterns
- In January, Novartis announced a partnership with Qualcomm Life centered on the use of Qualcomm’s 2net platform for collecting and aggregating device data during clinical trials
- In February, Sanofi announced its intention to run a fully remote clinical trial in diabetes in Europe
- Earlier this month, GSK and Purdue Pharma were reported to be exploring the integration of Apple’s ResearchKit as a platform for data collection in clinical trials
More recently, several developments suggest that the technology to enable these new models is advancing rapidly.
- Earlier this year, Proteus announced integration of their ingestible sensor platform with Oracle’s clinical trial data capture data and management solution, Health Sciences InForm, in order to capture medication adherence data in trials
- Last month, Google caused a stir by announcing that it is developing a wearable monitoring device specifically intended for clinical research
- On July 21st, Medidata and Validic announced a partnership that will make it easier to capture and analyze data from remote monitoring devices in clinical trials. This move will address some of the logistical challenges of capturing and using this kind of data in trials and is a step in the right direction, but significant questions remain about the validity and credibility of this data, the economics of these trial designs, and how regulators and payers will view this kind of data.
Pharma companies are clearly interested in this strategy and will become more active here over the coming years, especially in diabetes, cardiovascular disease, respiratory disease, and multiple sclerosis. The drug companies that figure out how to unlock the enormous untapped potential of these new technologies will have a valuable advantage over their less forward-thinking competitors.
Andrew Matzkin is a Vice President at Health Advances. Follow him on Twitter @MatzkinHealth
Opinions expressed here are solely those of the authors and do not reflect the views of Health Advances LLC, its management, or affiliates