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. 2023 Apr 13;7(1):e104.
doi: 10.1017/cts.2023.521. eCollection 2023.

Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience

Rhonda G Kost  1 , Rita K Devine  1 , Mark Fernands  1 , Riva Gottesman  1 , Manoj Kandpal  1 , Robert B MacArthur  1 , Barbara O'Sullivan  1 , Michelle Romanick  1 , Andrea Ronning  1 , Sarah Schlesinger  1 , Jonathan N Tobin  1   2 , Roger Vaughan  1 , Maija Neville-Williams  1 , James G Krueger  1 , Barry S Coller  1
Affiliations

Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience

Rhonda G Kost et al. J Clin Transl Sci. .

Abstract

Introduction: Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise.

Methods and results: Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies.

Conclusions: We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.

Keywords: CTSA; Clinical trials; metrics; translational research; translational science.

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Conflict of interest statement

A dedicated university counsel oversees clinical trial contracting, material transfer agreements, and the university’s conflict of interest program. She serves on both the ACCTS and the IRB, facilitating the flow of information on both topics to the appropriate committees.The authors have no disclosures to declare.

Figures

Figure 1.
Figure 1.
Overall organization of the Rockefeller University Center for Clinical and Translational Science, emphasizing the vital roles of the Translational Science Team Experts/Educators (TSEs) in supporting multidisciplinary research teams through 1. translational research navigation (TRN), 2. providing services to support protocol conduct, 3. leading workforce development educational programs, and 4. using CCTS metrics and novel outcome data to drive continual process improvement.
See this image and copyright information in PMC

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