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SURVEY: ABOUT HALF OF TRIALS WILL BE DECENTRALIZED IN THE NEXT 12 MONTHS

By Jenni Spinner contact

08-Sep-2021 - Last updated on 08-Sep-2021 at 13:33 GMT

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(reklamlar/iStock via Getty Images Plus)

Related tags: Decentralized trials, Virtual clinical trials, Remote patient
monitoring, Remote monitoring, Research, COVID-19


A survey on remote patient monitoring, conducted by health solutions firm
Vivalink, anticipates notable growth in virtual studies during the next year

Vivalink, a company offering connected healthcare solutions, has announced the
results of a survey checking in with pharma, clinical research, and biotech
professionals about remote patient monitoring (RPM). According to the findings,
the industry will see a significant increase in RPM technologies and
decentralized trial format over the next several months; COVID-19 is a driving
factor behind the growth.

Among the notable findings:

 * Nearly half (44%) already have adopted RPM, or plan to within the next 12
   months
 * About 65% noted concerns about the pandemic as the reason for using RPM
 * Approximately 94% indicated continuous data capture was somewhat or very
   important to their trials

Outsourcing-Pharma connected with Sam Liu, vice president of marketing with
Vivalink, about the survey, notable findings, and what the respondents’
perceptions and plans might mean for the industry.

OSP: Could you please talk about how the market’s adoption of DCTs has evolved
in recent years?

SL: The first phase of DCT focused on obtaining COA-related data remotely. This
limited the amount and automation of data capture and analysis due to largely
manual patient-reported symptoms or other observational data capture methods;
this is similar to the first phases of telehealth and telemedicine in the
healthcare provider world.
But now with today’s remote patient monitoring technologies, advanced software,
and back-end integration systems, eCOA is becoming more feasible to adopt. This
automates and accelerates data capture, analysis, and insights as well as
automating the data process end-to-end.





What has changed since COVID is the increase in interest and adoption of eCOA.
This was driven largely by the concerns around COVID such as avoidance of human
contact which impacted recruitment, enrollment, execution, etc. With a DCT/eCOA
approach, the trials are not limited to geography and thus can reach a wider
pool of subjects.

OSP: Please share an overview of remote patient monitoring—how that tech has
evolved, and the types of strategies and technologies sites/sponsors are
incorporating in their RPM plans.

SL: Much of the initial and current use of RPM technologies focused on patient
reporting via tablets, observations via video conferencing, and manual entries
into a computer system. It also made use of simple episodic devices such as BP
cuff, ear thermometer, weight scales, etc. While convenient, this also limited
the amount of data, contextualization, and insights that can be derived from a
patient.
With advanced RPM technologies (e.g. continuous monitors such as wearable
cardiac ECG patches or multimodal sensing) data can be captured automatically
and over an extended period of time. This has the ability to provide more
in-depth analysis and insights for applications that require or can benefit from
a larger dataset. For example, cardiac safety assessments of a therapeutic can
be based on continuous data from wearable ECG patches such that any anomalies
throughout a typical 24-hour circadian rhythm, or throughout activities of daily
living, can be comprehensively captured.

OSP: In your survey, a little under half of the respondents (44%) indicated
they’ve already adopted RPM in their DCTs or will soon. Could you share how the
others are handling their patient monitoring needs?

SL: Without the use of RPM technologies in DCT, it’s largely back to relying on
data reporting by patients or clinician observations, sometimes limited to a
clinic setting and manual entry into computer systems.

OSP: Of those respondents who haven’t yet taken on RPM in their
decentralized/hybrid trials—what are some of the factors that might be
contributing to the delay or hesitancy?

SL: Most are concerned with how patients will adhere to these new technologies
and also understanding the overall complexities of implementation of the system.
In Vivalink’s case, we design our technologies with the consumer in mind. We
focus on ease of use and comfort in order to minimize patient burden when
applying and using RPM without the assistance of a clinician. For the
clinicians, we automate and simplify the entire end-to-end system so that study
sponsors and sites are basically utilizing a service where the complexities are
largely handled by Vivalink.

OSP: You also share the concerns folks have about their RPM execution (i.e.
maintaining data integrity, continuous data capture, tracking important
physiological parameters, etc). How are trial professionals working to ensure
those concerns are addressed?

SL: This is part of our end-to-end systems design. Our technology stack includes
functions such as signal filtering for ambulatory and movement-based data
capture, on-board sensor memory for continuous data capture in the event of
network disruptions, data integrity checks to ensure data captured from remote
patients are successfully delivered to the cloud centrally.

OSP: What other notable findings in the survey would you like to share?

SL: Almost all the respondents felt that ‘continuous’ data was important as
opposed to just episodic. This speaks to the need for advanced RPM technologies
and a peek into the growth and adoption of RPM for DCT.

OSP: In what ways is Vivalink working to help organizations get solid RPM
solutions and strategies in place?

SL: We consider all aspects of helping our customers to ensure a successful RPM
for DCT implementation. This includes not just the technologies behind RPM but
incorporating the human factors of ease-of-use, operational issues with training
and support, and logistical challenges of getting devices to sites in multiple
countries.



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Related topics: Clinical Development, Clinical evolution, Patient centricity,
COVID-19, Phase III-IV, Phase I-II, Medical Devices, Data management

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