By Merrilyn Datta, PhD, Chief Commercial Officer, Definiens
Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.
Testing the Waters
When conducting clinical trials, drug companies today are seeking ways to monitor data in real-time as well as enable patients to come into clinical trial sites less often. Wearables may provide an opportunity to do just that.
The two main activity trackers on the market today – the Fitbit and Apple Watch – are currently capable of tracking vital signs such as heart rate, exercise and movement levels, and Apple’s ResearchKit can also track the gait of patients with Parkinson’s Disease. The devices also provide patients a way to report symptoms and events as they happen – for example, immediately entering “Today I felt pain after doing X”, rather than waiting to report the issue when they see their doctor two weeks later. This real-time data input is more accurate than human memory and may provide valuable information from a drug development perspective.
For example, GlaxoSmithKline is conducting a small study using a wearable to follow the movements of 25 patients with Lou Gehrig’s disease. The device measures patients’ heart rate, walking steps and elevation gain, and automatically sends the data to GSK for potential use in developing treatments for the disease. Similarly, Medidata Solutions recently conducted a study to explore the feasibility of using wearables in clinical trials by using the Fitbit and other mobile tools to measure activity levels and quality of life for patients with Type 2 diabetes.
Researchers are seeking to understand how monitoring certain vitals in real time may be able to help them make smarter decisions about their clinical trials and how to run them more effectively in the future, or adapt their current trials to be more effective based on data they gather at the beginning of the trial. The effectiveness of real-time data gathering for clinical trials of course depends on the endpoints being measured and whether wearables can support them, but there is promise for wearables to provide value here.
Additionally, real-time data gathering through wearables can reduce the amount of time a patient has to spend at a trial site, which can ultimately help improve trial enrollment rates. Clinical trial recruitment remains a challenge for the industry, and patients who still have treatment options at their disposal may be less inclined to participate in a trial if they are required to make a high volume of trips to the trial site for tests. However, if they can submit their data remotely through a wearable, the trial becomes more convenient and the barrier to entry is much lower.
Questions Being Raised
While tracking basic vitals like those mentioned above can support drug development and patient care, the topic of wearables is really of interest to drug discovery & development because there’s a potential for more sophisticated devices to enter the market. The industry is interested in whether devices that can go beyond basic fitness tracking to gather more valuable information, such as about a patient’s blood chemistry, can be developed and approved for use in clinical trials.
Having access to real-time data on a patient’s blood chemistry, such as glucose levels or metabolites indicating whether a drug is working, could help revolutionize clinical trials and drug development. However, in order to gather this kind of data, subcutaneous embedded or internal devices are often required rather than a traditional external wearable like a watch. There are already a few examples of internal and/or more sensitive devices being developed, such as the BioStamp and the Google contact lens, which will be able to monitor things like blood pressure, brain activity, seizure risks, exposure to UV rays, and glucose levels, but time will tell whether they will be approved for use in clinical trials.
Additionally, there are questions being raised about the quality of data that can be gathered from wearables versus collected through the traditional controlled clinical trial environment. Higher quantity doesn’t necessarily mean higher quality, and further, there are also challenges to work through with regard to data subjectivity and semantics – for example, if one patient tracks that he ran while another patient tracks that he ran and then walked, can those two data points be considered equal? With these variables, it’s unclear whether meaningful conclusions can be drawn from the higher volume of data being collected through wearables.
It is also still unclear how pharma companies will ensure compliance with data privacy regulations when leveraging wearables, which at this point remain non-standardized. Discussions around data security, accuracy and privacy with regard to wearables are heating up, but no clear solution or standard has been solidified as of yet.
Near Term Growth Opportunities
Addressing the challenges outlined above requires collecting more data and further testing the use of wearables before the industry can really know whether these devices are a viable addition to clinical trials and the drug development process. Thus, in the near term we’ll likely start to see trials where data is collected in different ways in parallel to determine if personal device data is of equal or lower quality to controlled clinical trials, and if that data can lead to meaningful conclusions. Early adopters will continue experimenting with collecting data from wearables to see where it leads them, likely starting with simple data points like activity tracking, and then adding more variables as time goes on to determine what kinds of conclusions can be drawn. This early “beta testing” so to speak will help define whether the industry as a whole invests more in wearable data gathering as well as standards development.
New technologies are also bound to be released, as companies seek to monitor more sophisticated kinds of patient data. This will be a defining year for the industry in terms of experimenting with new technologies, evaluating different approaches to data collection and clinical trials, and ultimately determining which ones will pay off best.
About the Author
Merrilyn Datta is Chief Commercial Officer of Definiens, the Tissue Phenomics company, and has more than 15 years of commercialization experience within the life sciences and biotechnology industry. Dr. Datta joined Definiens from Life Technologies where she held a variety of roles in marketing leadership, strategy, and mergers/acquisitions. Her specialty is commercialization of technology, innovation, and digital health,