Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials
Authors: Harris Paul A. , Dunsmore Sarah E. , Atkinson Jane C. , Benjamin Daniel Kelly , Bernard Gordon R. , Dean J. Michael , Dwyer Jamie P. , Ford Daniel E. , Selker Harry P. , Waddy Salina P. , Wiley Kenneth L. , Wilkins Consuelo H. , Cook Sarah K. , Burr Jeri S. , Edwards Terri L. , Huvane Jacqueline , Kennedy Nan , Lane Karen , Majkowski Ryan , Nelson Sarah , Palm Marisha E. , Stroud Mary , Thompson Dixie D. , Busacca Linda , Elkind Mitchell S. V. , Kimberly Robert P. , Reilly Muredach P. , Hanley Daniel F. ,   Trial Innovation Network, Greenberg Rachel , Zimmerman Kanecia , Smith Brian , Rockhold Frank , Poole Lori , Hickerson Jesse , Pham Eilene , Marion Eve , Boyle Helen , Miller Vincent , Sutton Sonya , Jones Michelle , Abbott-Grimes Princess , McBee Nichole , Mould Andrew , Eyzaguirre Lindsay , Singleton Megan , Maddox-Regis Janelle , Hillery Shannon , Nanni Angeline , Hildreth Meghan , Pessoa-Gingerish Cecilia , Bartlett Emily , Cohen Theodora , Wieber Cortney , Vermillion Krista , Rothwell Erin , Watt Kevin , Sward Kathy , VanBuren John M. , Pautler Mary , Kay Marie , Bridges Jordan , Ellis Krista , Sebahar Francis , Unsicker Eun Hea , Vasenina Valeriya , Morris Talmage , Aponte Michelle , Johnson Ann , Risenmay Annie , Rigtrup Lisa , Henderson Gary , Pate Ammon Leon , Lopez Monse , Boone Leslie , Byrne Loretta , Helmer Tara , Tischbein Maeve , Dunkel Leah , Mayers Stephanie , Quarles Kaysi , Bell Jasmine , Swindell Bridget , Ichimura Jabari , Ray Devan , Rantala Caitlin , Eidenmuller Jessica , Serdoz Emily , Dilts Natalie , Crenshaw David , Henderson Brooklyn , Vance Meghan , Burts Delicia , Grant Dione , Hamilton Jahi , Schorr Matt , Lawrence Colleen , Bernui Meredith , Budine Taylor , Baig Amna , Christodoulou Joseph , Cohen Jodie , Chen Tiffany , Dunagan Julia , Lloyd Wendy 
Published: October 2023

Importance

Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN’s challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support.

Observations

The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN’s impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.

Conclusions and Relevance

The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.