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PATIENT-CENTRIC MINDSET CAN ENHANCE INTERNATIONAL TRIALS: MEDABLE

By Jenni Spinner contact

08-Sep-2021 - Last updated on 08-Sep-2021 at 16:23 GMT

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(alengo/iStock via Getty images Plus)

Related tags: Medable, Decentralized trials, Virtual clinical trials


Two leaders from the decentralized trial solutions provider discuss the complex
pieces of a global clinical study and how to work to fit them all together.

Any decentralized clinical trial can be a highly complex project; when such a
study reaches across national borders into multiple countries, the equation
becomes even more complicated. Taking in all the variables presented by dealing
with people speaking different languages, observing different customs, and
facing different resources calls for a thoughtful, forward-thinking approach.

Keeping the patients themselves in mind can help increase the chances of
success. Outsourcing-Pharma recently spoke with two representatives from
decentralized trial solutions provider Medable about the ins and outs of running
international clinical research:

 * Alison Holland, head of decentralized clinical trials
 * Jena Daniels, vice president of patient success

OSP: Could you please share some of the differences in conducting international
trials, versus trials run in a more limited geographic area?

AH: When conducting international trials, it’s critical to accommodate different
national, regional, and local standards, regulations, and practices – at first
instance. For example, understanding the local data privacy governing
requirements is key to ensure we can deploy a global solution that meets the
highest rigor of all the geographics included.

OSP: How can trial teams ensure their DCTs consider key cultural, economic,
language, and other differences?

AH: In addition to the above, it is important to understand the local standards
of care available to patients and designing pathways into the study and
activities within the study that offer choices, all while focusing on central
data integrity and quality. For instance, consideration of local technology
standards and connectivity can influence which web and/or mobile application to
be deployed. Further, understanding connectivity support and local
infrastructure may require more provisioning of devices, or ensuring effective
off-line or backup features. 





It is vital to also consider the patient and site burden of the solutions being
implemented and assess the ease of their usage within the local environment,
particularly if patients reside in remote locations from any site or core
infrastructure. Of course, all patient-facing applications need to be deployed
in local languages. Often, we need to support five or more languages within a
single country so planning effectively for this is critical.

OSP: Could you please share an example of how failure to anticipate such
differences can lead to problems in trial execution?

Alison Holland, head of decentralized clinical trials, Medable

AH: When deploying decentralized study solutions, Medable always considers the
local socio-economic environments of the patients themselves – especially if
provisioning devices and sensors – and remaining mindful of local standards.
Smartphone devices that may be ubiquitous in some countries, may be seen as
irresistibly attractive and an unreasonable inducement for study entry if a
different device that can complete the same functions would be more aligned to
what is common in that geography.

Understanding all these factors, and the logistics, and provisioning workflows
are key to ensuring we are supporting all patients consistently around the world
and collecting evaluable and compliant data.

OSP: Is it ever possible to design a one-size-fits-all DCT—or to even come
close?

AH: At Medable, we believe it’s important to design and deploy DCT solutions
that offer consistent choices to sites and patients about how they can engage
within the study, offering flexibility where a protocol can safely accommodate,
for some or all activities, to be conducted in non-traditional bricks and mortar
settings. With this in mind, we all have different views on what would be an
attractive choice and therefore, a one-size-fits-all model is not fit for
purpose.

Being able to accommodate different workflows within a single study is key, for
example, and being able to utilize different consenting execution workflows
according to age, local legal standards, etc. means that several workflows need
to be available within a single study to maintain compliance and quality.

OSP: Are there ways DCT teams can partner with local researchers, healthcare
providers or other resources to help improve the access and inclusivity of their
trials, to ensure maximum patient engagement/retention, and minimal snags?

AH: Absolutely! DCTs enable us to make studies much more visible to a far
broader audience, bringing the study into the community and into the home and
providing more convenience and consumer-style choice to collect high-quality,
robust, and quantifiable data from participants from a location of their choice.

For example, collecting real-time patient diaries, together with wearable sensor
data for vital signs measurement allows many patients to remain out of the
traditional site but under the care of their clinical study team for symptoms
and health monitoring. In addition, trials augmented by local pharmacies and
community clinics can further improve trial access, enrollment, and retention.

By enabling local pharmacies to become access points or supplemental
investigator sites, for DCTs, 90% of Americans suddenly become within a
five-minute drive of a clinical trial. Not only does this provide greater
convenience for patients, but it also helps nurture greater trust because
patients are getting care from the people they know and see around town.

Jena Daniels, vice president of patient success

JD: To define a more human-centered approach to research and better embed the
patient and caregiver voices across the clinical development landscape, Medable
established its Patient Success team. Our network of diverse patients,
advocates, and caregivers provides their candid perspectives on every feature
and functionality of the Medable platform.

We incorporate their valuable feedback; their unique backgrounds, experiences,
and direct understanding of patient preferences make them an invaluable resource
to those intent on removing patient-facing barriers to participation in clinical
research. When properly implemented, the power of the patients’ and caregivers’
lived experiences can reduce protocol deviations, minimize trial dropout, and
improve patient engagement.

Through these kinds of engagements, we may be able to truly disrupt the clinical
trial model and redefine what it means to be human-centered…rather,
human-invested.

OSP: Does a CRO need to have its own international presence for international
trials to succeed?

AH: Medable partners with CROs and sponsors to enable clinical trials all around
the world. In fact, Medable’s software-as-a-service (SaaS) platform has been
deployed in more than 60 countries via more than 150 decentralized and hybrid
clinical trials to achieve unprecedented results – including 3X faster
enrollment, 90% retention rates, and 50% cost reductions.

Regardless of location, it’s very important to have a clear and informed
perspective of standards and practices locally and the regulatory and data
localization requirements for compliance. As such, we appreciate working with
CROs that have a local presence and, for some studies, this is critical for
compliance and other GCP-required processes but not mandatory for all studies.
We approach each study individually, on a trial-by-trial basis.

OSP: What other words of wisdom do you have?

AH: The world is rapidly changing and evolving as we adapt to our ongoing
pandemic ‘new normal’ making it more important than ever to enhance the quality
of clinical trials, the speed to drug decision-making, and the accessibility and
inclusivity of clinical research to patients around the world.

Designing and deploying DCT solutions focused on patient needs and preferences,
optimizing and amplifying their connectivity with clinical care, and collecting
real-time data will transform clinical trials in ways we’ve never seen before.
Specifically, we will begin to generate richer insights from machine learning
and advanced data analytics that will inform optimal disease and therapeutic
management and help the industry create effective, breakthrough treatments of
the future.



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Related topics: Clinical Development, Clinical evolution, Patient centricity,
Globalization, Phase III-IV, Phase I-II, Regulatory affairs, Data management

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