Sponsors and CROs running so-called “master trials” with digital tech should spend significant time on operational approaches, according to a new study.
The research – available here – focused on master trials, which are overarching protocols that cover multiple sub studies. Such studies – which are often classified as basket, umbrella or platform studies – are increasingly common in cancer studies, in part because advances in genomics have allowed tumor mutation types with a high degree of precision.
The difficulty, according to the researchers, is that “Master protocols in reality are 10 or more unique studies ‘disguised’ as one study and require arduous information flow with safety and efficacy evaluations that happen early and often.
The also said master protocols require “operational nimbleness, access to data in real- or near real-time, and the ability to quickly evaluate patient and protocol progress, ultimately unifying trial governance and optimizing oversight.”
The conclusions were based on the Beat Acute Myeloid Leukemia (BAML) Master Trial - sponsored by The Leukemia & Lymphoma Society – which made extensive use of digital and electronic technologies.
According to the authors, the idea was to see what impact combining a master trial approach with digital technology would have on study efficiency.
“Due to the complexity, workload, size and skills required to manage Master Trials, we hypothesized that a combination of modified traditional operational strategies and new e-technologies may streamline and improve data collection, enhance transmission and accessibility, and optimize oversight.”
And the findings were generally positive, although there were some challenges.
The authors wrote, “Sites may resist the new e-technologies initially because of the perceived potential to increase workload, decrease productivity and time required for training.
“This was overcome by using “technology change management” strategies: working directly with sites to train the staff on how to use the “systems” and stressing the benefits of the e-technologies.
The authors also said that the central communication platform established for the study was effective once all those involved were using it correctly.
“For a central communication/collaborative platform to be successfully implemented in a complex trial like the BAML Master Trial, all stakeholders—site, CRO and Sponsor staff must upload data and information frequently onto the platform.”
Ultimately, planning is the key factors according to the authors, who said, “to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches.
The added that, “The operational strategies and e-technologies, and the expertise of the CRO have facilitated the conduct and better management of the Master Trial.
“We believe the challenges and lessons learned from the approaches developed in this complex Master Trial can potentially accelerate drug development and expedite the achievement of our goal of improving clinical outcomes and can provide insights to those conducting Master Trials and adopting e-technologies.”