The “Beat AML Master Trial” assembles genomic experts from academic research institutes, pharmaceutical companies, and government organizations to identify targeted therapies to inhibit genetic mutations in AML.
Medidata's technology will be used across each of the AML protocols to streamline study data collection, review, and analysis, Mike Capone, Medidata’s Chief Operating Officer, told Outsourcing-Pharma.com.
“The system will allow LLS and INC Research to tailor the study database to the unique and specific needs of each trial and patient groups,” he added.
The trial launched at five cancer centers at the end of 2016 with four treatment arms currently in progress. Six additional clinical sites will enroll patients this spring and the trial will eventually expand to ten different treatment arms.
“The next steps for Medidata will be to work with INC Research to ensure proper database design for the six studies that are still under development,” said Capone.
The outsourcing arm
INC Research will be providing services including clinical monitoring, project management, medical support, and data management.
“We’re really providing an end-to-end solution for the Beat AML folks,” Nick Kenny, PhD, Executive Vice President of Clinical Development and General Manager of Oncology at INC Research, told us.
“[Beat AML is] like a small virtual biopharma that they’re running with us as their outsourcing arm,” he added, commenting that he would be “hard-pressed” to think of a more exciting activity that he’s been involved in.
“To get that kind of collaboration commitment to do one large umbrella … from a patient perspective is great, and from a physician standpoint, logistics of arranging patient flow is much more attractive,” said Kenny.
Managing an umbrella trial
With umbrella trials, Kenny said the major challenge is multiple protocols. As such, he said INC Research has to make sure it has “just in time training on each site in each protocol.”
However, it doesn’t expect one CRA at a site to manage ten protocols. Instead, the company has “triaged” management, with a group of CRAs responsible for groups of protocols, in order “to be experts in those protocols and not get to stretched,” Kenny explained.
“It’s a matter of really being able to forecast when each new protocol arrives and making sure we have the right people training and the sites are ready.”