Title : Innovations in clinical trials science
Abstract:
Why do so many federally funded clinical trials fail? There are critical roadblocks along the way such as slow study startup, delays in IRB approval and contracting, high costs, recruitment issues, complex study designs, lack of engagement of study teams, lack of data harmonization and simply too many data elements…just to name a few! Many studies are underfunded and under developed and then they get launched, which is a sure recipe for failure. In the clinical research community, it is well known that the road to a successful clinical trial is long and slow.
What if there were a national laboratory designed to solve these difficult problems? The Trial Innovation Network has been established in the US to do just that! The vision of the Trial Innovation Network is to innovatively address critical roadblocks in clinical research and accelerate the translation of novel interventions into life-saving therapies. The network is providing resources for all phases of clinical trial research to facilitate conduct of the highest quality multisite clinical studies in a time and cost efficient manner. This group is developing and demonstrating innovative designs and methods that will advance the science of clinical research and clinical trials.
Due to recent changes in US Common Rule regulations and the NIH Single IRB Policy, US centers participating in multisite research must use a single IRB for initial and ongoing ethical review of human subjects research protocols carried out at more than one site in the US. Study teams and IRBs are scrambling to come into compliance. Learn about innovative Central IRB (CIRB) workflows and resources developed by Trial Innovation Center (TIC) working groups at the University of Utah, Johns Hopkins, and Vanderbilt to operationalize and refine CIRB activities.
Additional initiatives are underway to further eliminate key roadblocks that impact the success of a trial. Hear specific examples from large pediatric and rare disease trials on how to streamline budget and contracting processes as well as data harmonization strategies. Specifically, at the University of Utah, initiatives driving innovation are in place that include: a local dataset of common study lifecycle metrics, use of an IdeaScale platform, and integration of value process engineering principles (e.g. lean methodology, process improvement) that all contribute to value-driven research. Hear about opportunities for nurses to manage large multisite trials. Nurses make excellent Project Managers. As part of our innovation teams, the Trial Innovation Centers are working to transform the long and slow road of clinical research into the clinical trials superhighway. Innovative workflows, tools and improved study design are paving the way for future research and playing an integral role in accelerating the translation of important research to the bedside for the benefit of our patients.
