Clinical Research Can Now Be Truly Patient-Centric By Quantifying Patient Burden with Medidata
June 25 2018 - 8:30AM
Business Wire
Patient Burden Index uses data-driven approach
to provide objective insight when creating trial protocols to
improve study retention and recruitment
To make clinical research truly patient-centric, Medidata
(NASDAQ: MDSO) announced the launch of the Patient Burden Index
(PBI) on the Medidata Cloud, the Intelligent Platform for Life
Sciences. PBI empowers sponsors and CROs to identify and address
high-burden procedures and visits that can impact patient
participation and retention in a clinical trial.
Medidata built a unique analytical approach to patient
centricity, solving complex study design and burdensome procedures
that currently lead to high patient dropout, execution challenges
and struggling investigators. The dropout rate for a clinical study
today is often very substantial, sometimes more than 30%.1 A recent
Medidata white paper outlines how incorporating factors such as
patient pain, anxiety, hospitalization, and other components of
patient experience into the initial trial design is instrumental to
a study’s success.
To address today’s challenges, Medidata developed the Patient
Burden Index, a component of the protocol optimization tool, Edge
Design Optimizer, to improve visualization of the patient
experience. PBI is built upon the industry’s largest pool of
patient data, and the deep industry knowledge of data scientists,
life science experts and developers at Medidata.
“Until now, assessing patient burden has largely been
subjective. PBI is the first solution of its kind that uses a
data-driven, objective approach to patient-centric trial design,”
said Glen de Vries, co-founder and president, Medidata. “PBI
empowers sponsors and CROs to address key challenges around study
experience and patient retention.”
By communicating the potential hardship of patient procedures,
sponsors and CROs can fine-tune protocol development and
operational plans. Medidata identified eight risk components for
researchers to address directly, including:
- Anxiety—the level of anxiety caused by
a procedure
- Pain—the level of physical pain caused
by a procedure
- Invasiveness—a procedure’s level of
physical invasiveness (e.g., blood draw; device implantation)
PBI is a new feature within the Edge Trial Planning and
Management family of clinical operations solutions. Edge is one of
three product families on Medidata’s unified platform, which are
powering the digital transformation of the entire clinical trial
process.
Medidata at DIA - Booth #1907: Visit Medidata at
DIA this week, and discover new ways to power smarter trials and
healthier people together. The company will host evocative thought
leadership and partner presentations, live product demos, and much
more throughout the three day event, including:
- Medidata + SHYFT: The Intelligent
Platform for Life Sciences - June 25, 4:45 PM EST
- Data Driven Insights for Study Design
and Operational Feasibility - June 26, 3:15 PM EST
About Medidata
Medidata accelerates the digital transformation of life sciences
through its unified platform, pioneering analytics, and unrivaled
expertise. The Intelligent Platform for Life Sciences seamlessly
delivers market-leading applications powered by artificial
intelligence and real-world analytics to reduce risk, optimize
revenue, and ultimately help patients.
More than 1,000 pharmaceutical companies, biotech, medical
device firms, academic medical centers and contract research
organizations around the world can now manage and optimize value
across the clinical and commercial continuum. For more information:
www.mdsol.com
1National Research Council, 2010, The Prevention and Treatment
of Missing Data in Clinical Trials, published by The National
Academies Press, p. 39
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version on businesswire.com: https://www.businesswire.com/news/home/20180625005344/en/
MedidataInvestors:Medidata SolutionsBetsy Frank,
+1 917-522-4620bfrank@mdsol.comorMedia:Medidata
SolutionsErik Snider, +1 646-362-2997esnider@mdsol.com
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