Modernizing Clinical Trials: Digital Technologies and the Cloud
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Published by FiercePharma
of standardized clinical data covering thousands of
trials from multiple sponsors that enrolled millions
of patients in all par ts of the world. Medidata has
stored the data on the AWS Cloud and through their
Synthetic Control Database™ is providing a unique
patient data source that is available, actionable and
consumable to improve decision making in trials
from design through submission.
Because Medidata's database is built on the AWS
Cloud, researchers can interac t with the Synthetic
Control Database via a highly customizable and flexible
visualization tool built entirely with AWS ser vices.
Among the many benefit s of using the Synthetic
Control Database, drug sponsors can more precisely
calculate sample sizes, improve statistical accuracy,
and understand the natural histor y of disease and
background rates of serious adverse events. Companies
that use the resource to improve decision-making
stand to increase accuracy, reduce costs and shorten
timelines in clinical trials.
UNLOCKING THE POTENTIAL OF
MOBILE TECHNOLOGIES
Clinical trial sponsors have traditionally generated
most of their data when patients visited trial sites,
but have lacked the ability to continually assess the
effect of their therapies on people as they went about
their everyday lives. The emergence of smartphones,
wearables, ingestibles and other devices has given
sponsor s new capabilities, enabling them to see
a fuller pic ture of the safet y and ef ficacy of their
products. Subsequently, these mobile technologies
rely on the cloud for secure and reliable transfer of
data to trial sponsors.
As the Clinical Trials Transformation Initiative (CTTI)
noted in recent recommendations,
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sys tems that
ensure the authenticity, integrity and confidentiality
of data over its entire lifecycle are essential to the
ef fec tive adoption of mobile technologies. These
sys tems mus t pull in data from multiple sources
and make it available to authorized users, without
compromising security.
AWS IoT ser vices like AWS IoT Analytics and AWS
IoT Device Management excel at connec ting such
physical devices to the cloud for secure data collection,
management and analysis. Teams across pharma and
healthcare companies want to incorporate wearables
or other devices into their trials and in some cases are
already pulling IoT and mobile device data into secure
cloud environments for analysis. For example, with
the suppor t of uMotif software on the AWS Cloud,
Manchester University in the United Kingdom ran a
research program looking at the effect weather had on
people suffering from rheumatoid arthritis and chronic
pain. According to uMotif CEO Bruce Hellman, 13,500
patient par ticipants used the app on their tablets or
smar tphones, provided 38 million data points and
7 CT TI Recommendations: Advancing the Use of Mobile
Technologies for Data Capture & Improved Clinical Trials.
Available at: ht tps://w w w.c t ti- clinicaltrials.org/sites/w w w.
c t ti- clinicaltrials.org/files/mobile - devices-recommendations.
pdf#Pg2Ln13. (Accessed: 7th September 2018)
