AUSTIN, Texas, Oct. 25, 2021 /PRNewswire/ -- COVID-19
physical distancing requirements forced change in how traditional
clinical trials were conducted and a new Informa Pharma and
Oracle study shows the industry is not looking back. Of the
251 people surveyed, 84% implemented alternative tactics to
continue their existing clinical trials and/or start new trials
during the pandemic. Of those respondents, 82% said these
approaches had positively impacted their clinical trials overall.
Looking to the future, 97% indicated their organization would
continue using at least one of these new methods moving forward,
leading with remote monitoring and video (eHealth) visits.
Did your organization implement new clinical trial methods during
the pandemic? 84% surveyed said yes.
"At the onset of the pandemic, the industry had to quickly adapt
to keep trials afloat and this forced change helped researchers
understand when and how to implement these approaches to improve
clinical research," said Henry
McNamara, senior vice president and general manager, Oracle
Health Sciences. "Methods and technology that were being explored
pre-pandemic have come front and center during the past 18 months.
As clinical trials continue to evolve, study teams can rest assured
that technology will help carry them into the future and speed new
discoveries."
The survey, Clinical Trial Management in a Post-Pandemic
World, polled participants from biopharmaceutical and medical
device companies, as well as CROs involved in the operations and
management of clinical trials from July to September 2021. Respondents, who were largely
from North America and
Europe, with others from APAC and
other regions, were asked about changes made to their clinical
trials during the pandemic, the effect of these adaptations, and
the impact of these changes on the future of clinical trials.
Newly implemented trial methods bring benefits to trials and
patients
Of the various methods noted, 45% of respondents said they had
adopted remote monitoring in their trials during the pandemic,
nearly doubling the number of respondents who reported using remote
monitoring a year ago. Among the newly adopted methods that
companies plan to continue to use post-pandemic, remote monitoring
(32%), video visits (28%), electronic health records (EHR) (24%),
and phone visits led the pack (24%).
The most common positive impacts of the alternative approaches
adopted during the pandemic included more timely data access (48%),
improved flexibility for patients (41%), and increased speed (38%).
When asked about their confidence in the data generated by newly
adopted approaches, 92% of respondents stated they were
equally or more confident in the data collected from these methods,
compared to data collected via pre-pandemic methods. This was a
marked change from the 2020 survey when nearly half of respondents
said that data reliability and quality (50%) and data collection
(45%) were key concerns in adopting decentralized clinical trials.
This significant increase in confidence supports the industry's
continued progress towards more decentralized models.
The study also found that improving the patient experience is a
priority. Many respondents (61%) believe allowing patients' choice
will have a positive impact on clinical research and well over half
(58%) said that their organizations plan to give patients the
option to choose how they participate in clinical trials moving
forward.
As the shift to decentralized trials continues, survey
respondents expect their organizations to continue using hybrid
(44%) and fit-for-purpose (42%) models after the pandemic. Of the
four models considered—site-based, fit-for-purpose, hybrid, and
decentralized—respondents expect the use of the site-based model to
decrease the most (24%).
"The COVID-19 pandemic challenged status quo and served as
a catalyst for the adoption of the technology-enabled
'patient-centric' decentralized clinical trials model," said
Dr. Nimita Limaye, research vice president, IDC. "As data
overflowed from diverse sources, data collection models
transitioned from 'discrete' data points to 'continuous' measures
and from 'local optimums' to unified cloud-native platforms.
The reality of this shift to the new norm has led to most
of the industry planning on continuing to implement newer
decentralized clinical trial models, with a significant reduction
in the traditional site-based model. It is evident that
patient optionality rules the day, with most organizations planning
on giving patients the choice about how they participate in
clinical trials."
To learn more about the study, join an in-depth webinar on the
research and findings on October 26th here or download
the full report here. Learn more about Oracle Health
Sciences Clinical One here.
About Oracle Health Sciences
As a leader in Life Sciences cloud technology, Oracle Health
Sciences' Clinical One and Safety One are trusted globally by
professionals in both large and emerging companies engaged in
clinical research and pharmacovigilance. With over 20 years'
experience, Oracle Health Sciences is committed to supporting
clinical development, delivering innovation to accelerate
advancements, and empowering the Life Sciences industry to improve
patient outcomes. Oracle Health Sciences. For life.
About Oracle
Oracle offers integrated suites of applications plus secure,
autonomous infrastructure in the Oracle Cloud. For more information
about Oracle (NYSE: ORCL), please visit us at oracle.com.
Trademarks
Oracle, Java, and MySQL are registered trademarks of Oracle
Corporation.
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SOURCE Oracle