Medidata’s Clinical Technology Platform Selected for Groundbreaking “Beat AML Master Trial”
March 23 2017 - 8:30AM
Business Wire
Medidata Provides Technology Infrastructure to
Power Clinical Research on Acute Myeloid Leukemia, Accelerating
Hope for New Blood Cancer Treatment
Medidata, the leading global provider of cloud-based technology
and data analytics for clinical research, today announced that The
Leukemia & Lymphoma Society (LLS) has selected the Medidata
Clinical Cloud® to power its novel trial for acute myeloid leukemia
(AML). Dubbed the “Beat AML Master Trial,” the clinical study is
designed to speed up approval of safer, more effective drugs to
treat AML, a complex group of more than 10 different prominent
blood cancers and many other rare cancers which causes
approximately 10,000 deaths in the US annually.
Today, less than one third of newly diagnosed AML patients
survive beyond five years. To treat the cancer more effectively,
LLS established a working group of renowned genomic experts from
academic research institutes, pharmaceutical companies and
government organizations focused on identifying targeted therapies
to inhibit the genetic mutations in AML. The working group’s use of
the Medidata platform is enabling vital, unprecedented
cross-industry collaboration—matching patients with one of several
different drugs selected to block a specific tumor mutation or
signaling pathway—and, in doing so, speeding up the efforts to
uncover new, targeted treatment options for AML patients.
“LLS has been at the forefront of AML research for decades,
leading the effort to understand the underlying causes of the
cancer and its different forms, and fund the development of vital
therapies for gravely ill patients,” said Medidata’s president Glen
de Vries. “We’re entering an exciting era in clinical research, and
Medidata is proud to be part of the Beat AML team, providing the
technology platform to power this ambitious umbrella clinical
trial—which is poised to increase the precision and success of
treatments for individual patients.”
INC Research, a leading CRO and longtime Medidata partner, was
selected to manage the unique, multi-treatment arm study based on
its extensive experience in the oncology and hematology fields.
Medidata is working closely with INC Research to deploy its
cutting-edge study conduct solutions across all research sites
participating in the Beat AML Master Trial, including its
integrated solution for electronic data capture, management and
reporting (Medidata Rave®) and medical coding (Medidata Coder®). By
streamlining trial operations, Medidata aims to help LLS speed up
drug approvals and increase treatment effectiveness for patients
suffering from AML.
In addition to leading pharmaceutical companies, more and more
top academic research institutes are joining the collaborative
initiative. Memorial Sloan Kettering Cancer Center, Dana-Farber
Cancer Institute, The Ohio State University Comprehensive Cancer
Center, Oregon Health and Science University’s Knight Cancer
Institute, and the General Hospital Cancer Center in Massachusetts
are the initial centers participating in the study, which aims to
enroll more than 500 AML patients.
“The Beat AML Master Trial is a great example of a precision
medicine approach to facilitate FDA approval of more
individualized, effective treatment approaches for patients
diagnosed with AML,” said Amy Burd, Ph.D., Vice President of
Research Strategy and Special Initiatives, The Leukemia &
Lymphoma Society. “This unprecedented gathering of renowned
academic researchers, pharmaceutical companies and leading
technology companies like Medidata will facilitate a collaborative,
fast-acting clinical trial consortium that represents a true
paradigm shift for AML as well as for clinical trials across all
types of cancer.”
Connect with Medidata
- Read our blog, Geeks Talk Clinical
- Tweet this: .@LLSusa selects @Medidata
#tech to power #BeatAML, its novel #precisionmedicine study for
acute myeloid #leukemia: http://ow.ly/WgPI30aauBK
- Follow us on Twitter: @Medidata
- Find us on LinkedIn
About Medidata
Medidata is reinventing global drug and medical device
development by creating the industry's leading cloud-based
solutions for clinical research. Through our advanced applications
and intelligent data analytics, Medidata helps advance the
scientific goals of life sciences customers worldwide, including
nearly 850 global pharmaceutical companies, biotech, diagnostic and
device firms, leading academic medical centers, and contract
research organizations.
The Medidata Clinical Cloud® brings a new level of quality and
efficiency to clinical trials that empower our customers to make
more informed decisions earlier and faster. Our unparalleled
clinical trial data assets provide deep insights that pave the way
for future growth. The Medidata Clinical Cloud is the primary
technology solution powering clinical trials for 17 of the world's
top 25 global pharmaceutical companies and is used by 16 of the top
20 medical device developers—from study design and planning through
execution, management and reporting.
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