Laura Khurana

Scientific and Operational Considerations of Wearable Devices in Clinical Trials


	
	There is increasing interest in incorporating data from wearable devices (activity and sleep trackers, heart rate monitors, smartwatches) into clinical trials. This is mainly due to the advantages sponsors, sites, and patients can recognize from their use. Sponsors can gain additional data to better understand a treatment’s effect on the participant. Investigative sites can use the data to monitor the patients’ health and to gain insight into the patients’ engagement. And, patients can potentially see metrics about their life and health they wouldn’t otherwise have access to.
	
	As existing wearables mature and as new products enter the market, the possibilities for their use in pharmaceutical research may be endless. By integrating varied data streams captured from wearables with electronic Clinical Outcomes Assessment (eCOA) data (symptom frequency and occurrence, quality of life, etc.) captured by the patient on handheld and/or web interfaces, sponsors may soon be able to gain complete insight into the patient experience during clinical development.
	
	However, there are many factors trial sponsors must consider before including wearables in their clinical trials. Here we present some of the scientific and operational considerations.
	
	


	
	Data from wearable devices can best serve the scientific objectives of a trial when they are:
	
	


	Trial sponsors should let the decision to use wearable data be driven by their ability to support the trial’s endpoints (or serve as independent endpoints themselves), rather than letting the choice of data collection technology drive the scientific questions of the trial.
	
	


	Data about sleep patterns, activity level, and physiological measures such as heart rate are only meaningful if you know the context in which this data was collected. Integration of wearable technology with eCOA enables the real-time capture of context surrounding a clinical event.
	
	


	Data from wearables that were originally created for commercial use may not be subject to the same standards of accuracy as medical devices vetted by the FDA. For example, a recently filed class-action lawsuit alleges that Fitbit® misrepresents the accuracy of the heart rate monitor in its wearable devices – this lawsuit was filed after university researchers attempted to validate the Fitbit monitor against an electrocardiogram (ECG) and found an average difference of 20 beats per minute.

 Other efforts are underway to validate wearable or smartphone data with existing COAs, including an app developed by Roche that uses smartphone sensor data to measure symptoms of Parkinson’s Disease and attempts to predict patient scores on the Unified Parkinson’s Disease Rating Scale (UPDRS).


	
	Beyond the scientific considerations of wearable devices, there are several operational aspects a trial team needs to consider when adding a wearable into the protocol, including:
	
	


	Prior to looking at any devices, sponsors need to determine what data is needed. There are hundreds of wearables on the market but you can quickly narrow the scope by knowing exactly what data you want to collect and for how long you want to collect it. An important consideration is if the data will be submitted to regulatory agencies, and if any regulatory precedent has been established for their use in clinical research.
	
	


	When people refer to wearables they often mean activity meters but the wave of innovation in wearables means there are options beyond just activity, including many that have multiple sensors. For example, Vital Connect has a wearable patch that collects single-lead ECG, heart rate, RR interval, respiratory rate, temperature, body posture, fall detection and activity including steps.
	
	Similarly, you can select the form that best meets your trial population’s needs. Maybe a wrist worn device works fine but perhaps a shirt like Hexoskin offers would be a better fit for your trial participants. Researchers are also working on minimal, tattoo-like health monitors that could be used in the future.


	Part of the patient centric movement in clinical trials is to understand the impact that trial requirements have on a participants’ life. This is especially important for wearables, as an uncomfortable device or one that requires extensive set up can lead to loss of data and non-compliance.
	
	


	Data from some wearables can be quite extensive, so it’s important to have a plan about what is a useful collection interval. Collecting a data point for every step may be more than you need, an alternative might be steps per minute or per day.
	
	

	The possibilities for wearables in clinical research are endless, but not all will meet the objectives of a given clinical development program. Having plan that addresses the scientific and operational considerations of wearables and optimizes the integration of data sources such as eCOA will lead to a smoother roll out, a higher likelihood of success, and potentially significant improvements in efficiency and accuracy during new drug research and development.
	
	

 is a Product Manager, ERT Innovation Lab

http://time.com/4344675/fitbit-lawsuit-heart-rate-accuracy/

http://www.roche.com/media/store/roche_stories/roche-stories-2015-08-10.htm

http://ucsdnews.ucsd.edu/pressreleas/temporary_tattoo_offers_		needle_free_way_to_monitor_glucose_levels

Articles

While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant’s progress, there are scientific and operational considerations to be aware of.

What Are You Wearing?

Learnings from a study of patient preferences regarding electronic Clinical Outcome Assessments (eCOA) in Clinical Trials


	
	Much research has been done to document patients’ preferences for electronic diaries (eDiary) over the traditional pen-and-paper approach. However, industry has had little insight into how patients prefer to interact with eCOA. This series presents the findings from a study conducted to understand what patients want when completing eCOA assessments during clinical trials.
	
	Read Part 1, 

“Improving Study Design and Logistics”


	
	Survey data from 408 patients with osteoarthritis, chronic obstructive pulmonary disease (COPD), depression, or type II diabetes were collected in the following categories:  patient engagement, compliance, ease of use, and feedback on specific eCOA features.  In total, 132 different questions were asked. The learnings indicate that even very simple changes in study design and user interface can go a long way toward adding a more human quality to the use of eCOA and promoting patient engagement during clinical trials.

		Patients strongly favored having a screen at the beginning of an eDiary that shows the number of questions and estimated time to completion.

		Patients preferred seeing their progress as they move through the questionnaire, either via a graphic progress bar or a “Screen X of Y” message.

		Most patients wanted to see a graphical summary of the symptom data that they report on a daily basis to see how it changes over time.  While this may be appropriate at the end of a patient’s participation in a trial, sponsors should carefully consider whether presenting this data during the trial could unblind patients to their treatment group or otherwise bias their future responses.

		Patients reported that they would be motivated to continue completing a daily eDiary if they saw a screen summarizing their diary compliance compared to the average compliance of patients in the study or a target compliance.

		Patients also resoundingly expressed a desire for a ‘thank you’ screen at the end of a diary.

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 3 covers how sponsors can humanize eCOA to help increase patient engagement during clinical trials.

What do Patients Want When Interacting with eDiaries? A 3-Part Series

	 	Much research has been done to document patients’ preferences for electronic diaries (eDiary) over the traditional pen-and-paper approach. However, industry has had little insight into how patients prefer to interact with eCOA. This series presents the findings from a study conducted to understand what patients want when completing eCOA assessments during clinical trials.	 	

 to view Part 1 of the series, “Improving Study Design and Logistics” which appeared October 6, 2016.	 	Survey data from 408 patients with osteoarthritis, chronic obstructive pulmonary disease (COPD), depression, or type II diabetes were collected in the following categories:  patient engagement, compliance, ease of use, and feedback on specific eCOA features.  In total, 132 different questions were asked. The learnings indicate that even very simple changes in study design and user interface can go a long way toward adding a more human quality to the use of eCOA and promoting patient engagement during clinical trials.	 	

		For larger eCOA screens (tablet and desktop), patients preferr a top-to-bottom question/answer layout which more closely mirrors the format of paper questionnaires, versus having question text on the left side of the screen and answer options on the right side.

		To show wording emphasis on an eCOA screen, patients prefer underlined words over other techniques (capitalized, bold, or italic wording).

		Patients prefer to see one question per screen, noting that this format is easier to read than displaying multiple questions per screen. While it may seem simple, this finding represents a bit of a paradigm shift in that it has long been surmised that fewer clicks or screens on the device would be preferable to patients and represent a shorter completion time and less patient burden.

		On handheld eCOA devices, patients prefer the navigation buttons (e.g., “Next” and “Back”) to be presented at the bottom of the screen, rather than the top of the screen.

		Given the option, patients prefer to use visual analog scales (VAS) that include text anchor labels, numeric indicators (e.g., 0, 50, and 100) and tick marks on the scale at regular increments, rather than a version of the VAS without numeric indicators or tick marks.

 of the series where we’ll review how sponsors can 

 to help patient engagement with eCOA during clinical trials. 	 	Susan Dallabrida, PhD and Laura Khurana, MPH, ERT	 

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 2 covers how sponsors can improve upon their user interface of electronic diaries.

	 	Much research has been done to document patients’ preferences for electronic diaries (eDiary) over the traditional pen-and-paper approach. However, industry has had little insight into how patients prefer to interact with eCOA. This series presents the findings from a study conducted to understand what patients want when completing eCOA assessments during clinical trials.	 	Survey data from 408 patients with osteoarthritis, chronic obstructive pulmonary disease (COPD), depression, or type II diabetes were collected in the following categories: patient engagement, compliance, ease of use, and feedback on specific eCOA features. In total, 132 different questions were asked. The learnings indicate that even very simple changes in study design and user interface can go a long way toward adding a more human quality to the use of eCOA and promoting patient engagement during clinical trials.	 	

Part 1:  Improving Study Design and Logistics

		Patients slightly prefer evening over morning for eDiary completion, but rate both windows of the day quite favorably. Shorter windows of completion are preferable.

		Patients are willing to engage in trials using daily eDiaries for considerable periods of time, including 5 years or longer, but prefer studies of 1-2 years or less in duration.

		Patients indicate the strongest preference for having an electronic device provided to them, rather than using their own smartphone device for participation in a clinical trial.

		Most patients think it would be helpful to have audible alarms on a study-provided eCOA device to remind them to record their disease symptoms or take their medication.

		Most patients express interest in using electronic methods (e.g., smartphone app, email, text messages) to interact more with their physician between clinic visits to help manage and treat their disease.

	Check back next week for Part 2 of the series where we’ll review how sponsors can Improve eCOA User Interface to help patient engagement during clinical trials.

	Susan Dallabrida, PhD and Laura Khurana, MPH, ERT

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 1 covers how sponsors can improve the study design and logistics of electronic diaries.