NCATS Trial Innovation Network Tackling Clinical Trial Inefficiencies

Doctor chatting with patient

John N. Clore, professor of medicine and associate vice president for clinical research, speaks with patient Colleen A. Thoma, as she undergoes a test to monitor brain wave activity. (Virginia Commonwealth University Photo/Tom Kojscich)

Through NCATS’ new Trial Innovation Network, Clinical and Translational Science Awards (CTSA) Program-supported investigators are working collaboratively — including with the CTSA Program Trial Innovation Centers (TICs) and Recruitment Innovation Center (RIC), as well as with other NIH Institutes and Centers — to tackle inefficiencies in clinical trials. The Trial Innovation Network also is designed to be a national laboratory to study, understand and innovate the processes for conducting multisite studies so that more treatments can reach more patients more quickly.

For example, network investigators are establishing a harmonized, central institutional review board (IRB) system among the IRBs at Vanderbilt University Medical Center, the University of Utah, and Johns Hopkins University. Efforts include developing workflows, processes and resources to harmonize network IRB reviews and to pilot the NIH single IRB policy. And, in partnership with the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB team, they will develop metrics to assess the time, costs and resources data required to operationalize an IRB review that uses the SMART IRB Authorization Agreement (PDF - 449KB).

Network investigators are also developing a Standard Agreement System for contracting for network trials and studies. Their work includes guidance for using the Federal Demonstration Partnership Clinical Trials Subaward Agreement (FDP-CTSA) and metrics to capture data on the impact of this harmonized template for contracts.

In addition, the Trial Innovation Network investigators are implementing a strategic, multidisciplinary, evidence-based approach to optimize participant engagement, recruitment and retention and will develop metrics, milestones and processes. TIC grantees will help ensure protocols address scientifically relevant questions by streamlining study designs, developing realistic eligibility criteria based on target populations and optimizing data collection. The RIC grantees will conduct evidence-based feasibility analyses and support data-driven cohort discovery. RIC grantees are also providing expertise in engaging participants, developing tailored recruitment plans and materials, and using creative approaches to target potential participants.

All researchers can access network services and consultations by submitting proposals through the Trial Innovation Network website, which features resources, instructions and materials for the submission process. The website includes information on operationalizing standard agreements and a central IRB, as well as feasibility assessments, recruitment materials and Community Engagement Studios. Trial Innovation Network initial consultations include suggestions on study design, budgets, projected timelines, recruitment and study feasibility. Based on the outcome of an initial consultation, a proposal may be eligible for a comprehensive consultation and development into a protocol that would be implemented in the network.

Posted April 2017