Jawbones and Heart Bands - How e-devices will revolutionize clinical research
By: Avi Kulkarni | November 05, 2015
When I attended the recent Bio Investor Forum in October as a panelist and Quintiles representative at a session titled “Stretching Your Dollar: Methods and Tools for Increasing the Productivity of Clinical Trials,” I was prepared to listen to numerous presentations about how to incrementally drive costs out of the clinical trial process. But what I heard was far more interesting than I ever anticipated. While cost reduction was an overall theme of the session, the really exciting discussions focused not just on simple efficiency steps, but on how we can harness innovative technologies and connected devices to change the way we interact with patients and gather data. The result: trials can be faster, more efficient, and better for patients – all while delivering cost savings that are significant enough to bring once-discarded drugs to market.
The comfort of home
A perfect example discussed at the event was research into treatment for sleep disorders such as sleep apnea. Due to the complicated and costly processes necessary to study sleeping patients, this category of research has faced extreme cost barriers that have lead more than one promising drug to be discarded. The challenge is that bringing patients into a high-tech center for hours-long sleep trials is not only cost-prohibitive, but because the setting is so foreign to patients, their sleep patterns in the studies are disrupted making the data unreliable. That means more patient studies are needed to tease the signal from the noise, which drives costs up further, and ultimately leads to failure. But now, consumers and physicians have access to a variety of consumer and medical wearable devices, like Fitbit, Jawbone, and SleepRate, that gather detailed information about a user’s sleep habits in their natural environment (i.e., their own beds). That data can then be downloaded to a database, giving physicians access to a wealth of reliable sleep data with no costly sleep center studies.
By harnessing these readily accessible but incredibly innovative wearable devices, sleep apnea research can now be conducted at a fraction of the previous cost, which means promising potential drugs have a real chance of getting approved.
I Heart Apps
Dr. Michael McConnell, a Stanford cardiologist and director of the MyHeart Counts study, discussed how cardiac patients in this study are wearing lightweight heart bands and using the MyHeart Counts mHealth app to transmit data tracking their current cardiac health status, including clinical variables such as blood pressure and behavioral variables such as exercise. By gathering this data remotely, physicians can eliminate the need for frequent, time-consuming follow-up visits, which reduces the time and cost of care, improves the patient’s care experience, and gives doctors more comprehensive real world data about the patient’s health.
In response to moderator Lawrence Klein’s comment about the utility of these approaches in clinical trials, speakers Noah Craft of Science 37 and Matthew Noble of MediData discussed how clinicians can use mobile devices to more easily reallocate patients in adaptive trials, which cut the number of patients needed in the trial, and makes changes easier for the clinical team and the patients. This session once again demonstrated how these devices can reduce the time, cost and complexity of trials.
Delve deeper at EVF
Many companies shy away from introducing new technologies to their clinical trial processes because they fear the consequences of bringing unknown tools into the research environment. They often argue that regulators will not approve, yet regulators are the ones pushing the use of these devices in trial design. For example, in 2014 the US Food and Drug Administration proposed a strategy and recommendations for a risk-based framework to regulatory oversight, focusing only on devices or apps that would pose a risk to patient safety if they did not function as intended. In an unprecedented turn of events, regulators are being more innovative than the biopharma companies. That should tell you something about how ready our market is for these innovations.
I am excited to continue these conversations about the benefits of wearables and other innovative technologies at the 2015 Quintiles Executive Vision Forum, where industry leaders, will come together to discuss the current and future trends in the biopharma space. Keynote speaker, Dr. Eric Topol, will specifically delve deeper into the use of devices and other technologies to improve the clinical trial process.
Clearly the time has come for the biopharma industry to embrace this new technological path, not just because it will cut our costs, but because it will fundamentally change the way we conduct research and engage with patients in the future.