Digital innovation in clinical trial research has been accelerated because of the COVID-19 pandemic. Wherever possible, in-clinical assessments are being replaced with measures taken outside the study site. Decentralized trials present a new challenge to accurately capture data in real-world settings, such as the home or workplace. Here we illustrate how an outcome measure from a wearable sensor can be used as an alternative to the 6-Minute Walk Test (6MWT).
What is a Decentralized Trial?
The FDA defines decentralized clinical trials as those executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model.1
Decentralized clinical trials are conducted remotely, with patient subjects remaining at home during a significant portion, or all, of the study.
Benefits of Wearable Sensors in Decentralized Trials
It is necessary to understand how treatments improve the health-related quality of life (QoL) for patients, including their experience of specific symptoms. Regulatory agencies recognize the importance of the patient-centric approach to drug development. The expanding use of wearable sensor technologies allows the collection of clinical trial data directly from the body connecting the patient in a way not previously possible. Decentralization trials benefit patients, sponsors, and sites, providing insights not previously measurable.
In-clinic Assessment Using 6-Minute Walk Test (6MWT)
In-clinic patient assessments are performed in-person, under the supervision of study personnel at a conventional study center or medical clinic. These assessments may include metabolic or physiologic measures combined with subjective patient data from electronic diaries (ePRO) and electronic Clinician Outcome Assessments (eCOA). The in-clinic 6-Minute Walk Test (6MWT) has been widely used across therapeutic specialties to measure the impact of new drugs on physical activity and has been the cornerstone of clinical assessment for over 40 years. Initially utilized in cardiology and now in many other disease states, it is administered in-clinic and requires the following:
- Trundle wheel to measure the distance covered
- A 30-meter stretch of unimpeded walkway
- Two cones to mark the distance that needs to be covered
The object of the test is to walk as far as possible, between the two cones, for 6 minutes. The patient walks back and forth on the walkway and is permitted to slow down, stop and rest as necessary.
Can the 6MWT Be Performed in the Real-world?
An in-clinic measure, such as 6MWT, cannot be easily administered in the real-world for several practical reasons. 6MWT requires that the study subject/patient walks at a comfortable pace between two cones placed 30 meters apart, on a flat surface, and in a straight line. Finding a suitable large, flat space required to complete this type of test may not be possible in real-world settings. For patient safety, the 6MWT is supervised by site personnel to avoid the possibility of falling or overexertion and to provide motivation to continue walking for the full six minutes. This type of supervision, provided by a caregiver, may not be readily available at home. How then may we substitute and perhaps eventually replace 6MWT with a measure made using a wearable sensor in a way that more accurately reflects real-world functioning?
B6ME Is a Real-world Solution
Best 6-Minute Effort (B6ME)™ is a novel outcome assessment that helps researchers understand how disease impacts patient functioning. It identifies the best six-minute effort whenever the patient happens to make it. B6ME provides a continuous measure of physical activity, steps taken, distance walked, cadence, duration of effort, and time of day at which this effort occurred. An in-clinic 6MWT is made at a predetermined time when the study subject may be preoccupied or fatigued. Using a wearable sensor to measure B6ME, a detailed understanding of functional mobility can be derived. B6ME provides accurate insight into how patients function during their everyday activities, reducing the need for burdensome on-site visits.
1. What are decentralized clinical trials? (2020, May 15). Retrieved March 08, 2021, from https://www.biorasi.com/what-are-decentralized-clinical-trials/
2. Balke, B. (n.d.). Six Minute Walk Test (SMWT). Https://Www.Rheumatology.Org/. Retrieved March 8, 2021, from https://www.rheumatology.org/I-Am-A/Rheumatologist/Research/Clinician-Researchers/Six-Minute-Walk-Test-SMWT
3. Crager, J. (n.d.). Leveraging Digitally Reported Outcomes in Clinical Trials. Www.Pharmasalmanac.Com. Retrieved March 8, 2021, from https://www.pharmasalmanac.com/articles/leveraging-digitally-reported-outcomes-in-clinical-trials