Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.
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2023-01
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One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
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Lane, Karen, Marisha E Palm, Eve Marion, Marie T Kay, Dixie Thompson, Mary Stroud, Helen Boyle, Shannon Hillery, et al. (2023). Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network. Journal of clinical and translational science, 7(1). p. e131. 10.1017/cts.2023.560 Retrieved from https://hdl.handle.net/10161/29267.
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Daniel Kelly Benjamin
Dr. Danny Benjamin is the Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network. The Network is responsible for designing and leading clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The team has established, or is actively studying, the correct dosing and safety of more than 100 of the most commonly used medicines in children. These trials are conducted under an Investigational New Drug (IND) application with guidance from the Food and Drug Administration for labeling.
The Pediatric Trials Network has directly impacted the healthcare of over 90% of American children.
Signature programs of the Network include clinical trials in premature, term infants, breast feeding mothers, and obese children. Over the past 10 years, Danny’s group has enrolled more premature infants, at more sites, in more clinical trials of off-patent anti-infectives under an IND than all other academic medical centers, pharmaceutical companies, and government agencies in the world, combined.
Danny is recognized by the National Institutes of Health as a premiere mentor and educator. His research program serves as a platform to train students and early career investigators. Danny’s group has a clinical research summer program for high school, college graduate school, and medical students that recruits and mentors ~30 students each academic year. He has been the primary or secondary mentor for 10 faculty who have received career development awards and who have then gone on to establish their own independent research programs; six of whom are now Distinguished Professors.
Danny's service to the community is expressed through his passion for coaching baseball. He has coached over 1,000 recreation league, travel league, and scholastic baseball games. He is the head coach for Smith Middle School Baseball, perennially southern conference champions. Danny and his wife own a charitable non-profit that provides athletic and fitness opportunities for disadvantaged and special-needs school-aged boys and girls.
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