By Benjamin Ross

May 3, 2017 | Wearable devices are quickly gaining ground for consumers. Kanter, which launched a wearables report last year, estimates that 16% of US consumers own a smartwatch or fitness band. However, there are no standards for wearable devices in life sciences research. This is an issue that greatly concerns the Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D.

“Wearable and connected devices will be valuable in capturing patient information during clinical trials, and we are already seeing collaborations between pharma and technology (e.g. IBM and Pfizer) using devices,” Steve Arlington, President of the Pistoia Alliance, told Clinical Informatics News via email.

The IBM and Pfizer partnership Arlington references has been ongoing as early as last April. Focusing on Parkinson’s disease, IBM and Pfizer launched a research project that would use off-the-shelf sensors and mobile devices to provide around-the-clock disease symptom information to researchers and doctors. The idea behind the partnership was to take the idea of personalized care to a new level.

“But as the life sciences industry is asked to do more to incorporate these kinds of technologies into their remit, the complexity of R&D continues to deepen,” Arlington said.

A lack of collaboration between pharma companies regarding a set of data standards has worked itself into a loop. Pharma companies don’t want to share data if it means collaborating with another company’s standards, which means that no standards are made.

At a Pistoia Alliance event, Sohini Chowdhury, senior vice president of research partnerships at The Michael J Fox Foundation (MJFF), outlined the Foundation’s early wearable device projects. One project includes a wearable sensor in a smartwatch, which transmits data via a smartphone to the cloud. This enables researchers to monitor patients’ movements around the clock, collecting 150 data points per second (over 4 million data points per person per day).

That much data presents analysis challenges, and Chowdhury advocated for collaboration between data scientists and clinical experts. That kind of collaborative effort will become fundamental to unearthing insights from wearable device data and is a core aim of The Pistoia Alliance, the Alliance said in coverage of Chowdhury’s presentation.

Cross-Company Agreement

But data challenges are even greater if data are to be shared between companies. “The biggest issue is that data formats in use vary widely between companies; some may be using off the shelf tools, while others may have invested millions in building their own in-house systems,” Arlington told Clinical Informatics News. And wearables are just one of many new data sources that could be aggregated to improve care. “[There are] the growing number of data sources and types – from a wearable device in a clinical trial, to a patient’s social media post. As a result, we will see future issues around data standards, uniformity in data quality, device quality, and the issue of privacy – rendering the data gathered far less usable,” Arlington said.

He argues that an umbrella corporation will have to step in and say, “This is what we’re going to do and how we’re going to do it.” That’s not to say that the Pistoia Alliance is gearing up to take that role. The call to arms, so to speak, is merely a general urging from Arlington for collaboration from within the industry.

There is already a political will behind this notion. Recent events, such as President Trump’s push to lower drug prices, show that people are antsy to see the pharmaceutical industry make changes in some form, whether willingly or by force.

Wearable devices seem the best place to start. According to Nick Lynch, one of the Pistoia Alliance’s founding members and a current External Liaison and Advisor at the Pistoia Alliance, using wearable devices for gathering data in clinical trials provides a higher density from which researchers can access the desirable information. When devices are incorporated into patients’ everyday routine, then more accurate data will come from that, provided there are standards in place.

Even with questions abounding on how to use the data, Arlington maintains that wearable devices are valuable now. “When [the wearable device technology]’s available, use it.”