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