On March 23, the leading provider of data-analytics and cloud-based technology for clinical research, Medidata Solutions, Inc. announced that its technology called Medidata Clinical Cloud® will be used for the groundbreaking clinical study.
The Leukemia & Lymphoma Society (LLS) selected the mentioned technology for a novel trial conducted for finding a treatment for acute myeloid leukemia (AML). AML is a type of blood cancer that affects bone marrow and interferes with normal blood cell production.
After AML effects on bone marrow, abnormal white blood cells are growing, causing the number of normal white cells and red blood cells to decrease.
Blood cancers together are the cause of more than 30% of cancer deaths in the United States. AML is the most lethal of them and takes away the lives of more than 10,000 people annually.
For more than 40 years the treatment of this disease remained the same: a combination of different highly-toxic chemotherapies. For patients older than 60, the five-year survival rate is less than 20%.
A new clinical study was designed to make approvals of the most effective and safe medications quicker for patients with AML, and was also dubbed the 2016 study, “Beat AML Master Trial” and will enroll more than half a thousand of patients from participating healthcare facilities.
Beat AML Master Trial
Announced on October 18 last year, it was one of the first cancer clinical trials led by a non-profit organization. It allowed multiple pharmaceutical companies to bring their drugs that would be used during the trial for different subtypes of AML at the same time.
The study was launched at the Dana-Farber Cancer Institute, Massachusetts General Hospital Cancer Center, the Ohio State University Comprehensive Cancer Center, Oregon Health and Science University’s Knight Cancer Institute, and Memorial Sloan Kettering Cancer Center.
Patients were re-diagnosed each time they relapsed. It helped to monitor any changes in their health and prevent any genetic mutations that are common for people who relapsed. In case of the detection of these anomalies in their early stages, scientists could change the treatment and provide their patients with another one that would be more effective and save.
Thus, this study provided sophistication and speed between AML diagnosis and treatment. Also, during Beat AML, patients also reported about any events that could be connected with their treatment.
Current study with Medidata platform
In order to treat patients with AML more effectively, a working group of genomic experts was established by LLS. This group includes experts from pharmaceutical companies, academic research institutes, and government organizations focused on finding specific therapies for inhibition of genetic mutations in AML.
The Medidata Clinical Cloud platform will be used by the working group for their cross-industry collaboration. With its help, the group will be able to match a specific anti-AML drug with patients with a specific tumor mutation in their body.
This approach should be very effective and will increase the speed of development of new, targeted treatment for each subtype of AML in different patients.
Glen de Vries, Medidata Solutions Inc. president, said that LSS was leading the effort to understand the underlying causes of cancer and its subtypes. He pointed out that LSS was on the front of AML research for decades and funded the development of vital therapies for the patients.
He also added that they were entering an exciting era in a clinical study and his company was proud to be part of the Beat AML, providing the technology platform for this clinical trial. De Vries also said that this trial poised to increase the success of individual treatments.
INC Research and Medidata Solutions collaboration
For managing multi-treatment study INC Research contract research organization, a partner of Medidata, was selected. This choice can be explained by its experience in hematology and oncology fields.
During their participation in the Beat AML Master Trial, Medidata Solutions along with INC Research deployed the solutions for the clinical trial across all the sites of the research.
These solutions included Medidata Rave® and Coder® systems. Rave system is the integrated solution for data capture, reporting, and management. Medidata Coder is designed for medical coding, making it more cost-efficient and faster. Also, Coder reduces consistency risks during the trial.
Medidata’s solutions are helping LLS to increase treatment effectiveness and speed up the U.S. Food and Drug Administration (FDA) drug approvals by streamlining trial operations during the Beat AML Master Trial.
Amy Burd, Ph.D., LLS’s vice president of Research Strategy and Special Initiatives, said that the Beat AML Mater Trial was a great example of a precision approach for making easier anti-AML drug approval of more effective and individualized treatment approaches for patients with AML.
She also added that unprecedented gathering of widely-known academic researchers, leading technology and pharmaceutical companies will facilitate a fast acting clinical trial consortium, which represented a true “paradigm shift” for clinical trials across all types of cancer, especially AML.