WearablesGetting Started With Wearables in Clinical Trials

By Martina Donohue & Geoffrey Gill

Few will disagree that pharmaceutical development costs too much and takes too long. Drug development often lasts longer than a decade and costs anywhere between $2 and $3 billion, according to a Tufts Center for the Study of Drug Development R&D Cost Study [1]. It is also widely accepted that wearable sensors create the potential for new endpoints that can reduce cost, shorten clinical trials, and focus trials on real-world data. [2]

The key word in that statement is “potential.” These digital endpoints need to be validated and accepted widely – both by industry and regulatory bodies – to achieve the full potential of wearable data. As a result, most sponsors are layering wearable sensors onto existing trials – often with a subset of participants – to generate exploratory endpoints. We have some recommendations to maximize the value of this exploratory work.

Leverage Academic Research

There are literally tens of thousands of person-years of academic and other public domain research into the analysis and interpretation of wearable sensor data. Shimmer Research, our firm, has sold sensors to thousands of research customers in more than 75 countries for more than 10 years. This is a treasure trove of analytic work that no single firm – no matter how big and successful – can hope to replicate. But the reality is that they shouldn’t want to. No pharmaceutical firm can gain competitive advantage by creating a new way to analyze wearable data in clinical trials. In fact, just the opposite. Wearable data will only become truly valuable when there are endpoints that everyone – both industry and regulators – can agree are meaningful measures of real-world patient outcomes. So leverage all the work that has been done.

 

Choose the Right Wearable

Choosing the right wearable is obviously important. We see five key factors to look for in a wearable sensor platform.

1. Raw Data

We talked about leveraging academic work. One of the key prerequisites to make that possible is to have the complete raw sensor data available for analysis. But there are many other reasons why the raw data are critically important. As algorithms improve over time, you can update analyses and improve them as long as you have access to the raw data. It will be more difficult to get regulatory buy-in without it. Furthermore, raw data are generally very comparable between different sensor platforms, whereas many companies use proprietary analyses in order to lock you into their systems. We believe that the single most critical factor in choosing a sensor platform is the availability of the raw data.

2. Low Burden

Of course, you won’t get any data at all if the participants have low compliance. Wearing a sensor is one more thing for participants to do, sites to deal with, and sponsors to analyze. Try to find the sensor with the lowest burden for all of the stakeholders.

3. Systems to Ensure Data Integrity

No matter how low burden the wearable is, you will still need to monitor compliance and address issues. Choose the sensor with multiple data redundancy features and a management system that allows you to monitor the data collection in real time.

 

4. Open Algorithms

To gain widespread acceptance, we believe that the algorithms used will need to be transparent to both sponsors and regulators. No one will be comfortable with a black box algorithm.

5. Flexible Platform

There are significant benefits to choosing a vendor that can support multiple different sensing requirements with a single platform: it reduces the number of times you need to integrate different systems and you can start to build a partnership with that vendor.

 

Take Advantage of Service Offerings

By this point, it should be clear that no matter how good the wearable system that you choose, it will be extra effort added to the already complex process of a clinical trial. Leverage the experience and capacity of your wearable supplier to shoulder the burden. Not only are they likely more experienced in collecting and analyzing wearable data, they may be able to identify and access academic research more easily. Over the years, our company, Shimmer, has built relationships with literally thousands of researchers. This has helped us facilitate introductions and collaborative research between our customers and the researchers.

One final comment to sponsors – please share data to the extent possible given privacy and other considerations. The industry needs to establish commonly-accepted endpoints and it cannot do that without data. While you may not be willing or able to share data with competitors, use your vendors and/or third-party aggregators to build this knowledge base. If we work together, we can hasten the day when we are able to truly achieve the potential of digital endpoints.

Martina Donohue is marketing manager at Shimmer Research and Geoffrey Gill is president of Shimmer Americas. Founded based on Intel technology in 2006, Shimmer Research is a well-established wearable technologies services and sensor manufacturing company based in Dublin, Ireland.

 

References

https://csdd.tufts.edu/csddnews/2018/3/9/march-2016-tufts-csdd-rd-cost-study

See, for example, CTTI recommendations and our Journal for Clinical Studies paper.

This post has been sponsored by Shimmer Research