Medidata's Clinical Technology Platform Selected For Groundbreaking ‘Beat AML Master Trial'

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, recently 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 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.”