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. 2023 May 25;7(1):e131.
doi: 10.1017/cts.2023.560. eCollection 2023.

Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network

Karen Lane  1 , Marisha E Palm  2   3 , Eve Marion  4 , Marie T Kay  5 , Dixie Thompson  5 , Mary Stroud  6 , Helen Boyle  4 , Shannon Hillery  7 , Angeline Nanni  7 , Meghan Hildreth  1 , Sarah Nelson  8 , Jeri S Burr  5 , Terri Edwards  6 , Lori Poole  4 , Salina P Waddy  9 , Sarah E Dunsmore  9 , Paul Harris  10 , Consuelo Wilkins  11 , Gordon R Bernard  6 , J Michael Dean  5 , Jamie Dwyer  5 , Daniel K Benjamin Jr  4 , Harry P Selker  3   12   13 , Daniel F Hanley  14 , Daniel E Ford  15
Affiliations

Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network

Karen Lane et al. J Clin Transl Sci. .

Abstract

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.

Keywords: Multicenter trials; Trial Innovation Network; clinical trial budgets; clinical trial resources; informative trials; study planning.

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Conflict of interest statement

Co-Author, Daniel K. Benjamin, Jr., Duke Clinical Research Institute, reports consultancies with AbbieVie, PPD, and Syneos Health. No other authors have declared conflicts of interest or financial involvements that might potentially bias their work.

Figures

Figure 1.
Figure 1.
The multicenter trial life cycle can be divided into five stages. When scaling up from a single center trial, planners in stage one must operationalize the study for multiple settings and a more diversified participant population. To assure informativeness, the startup second stage requires more effort directed to training and quality assurance oversight to ensure teams provide an intervention consistently during stage three. The rewards are realized in stages four and five, when data quality is confirmed, and the results of the trial inform medical practitioners, participants, and communities.
Figure 2.
Figure 2.
A sample organizational structure that outlines how a framework of essential management units and roles interact to support multicenter trial activities and enhance the informativeness and quality of a clinical trial.
Figure 3.
Figure 3.
The Trial Innovation Network (TIN) offers a variety of network resources throughout the planning and implementation phases of multicenter clinical trials, each providing opportunities to further the informativeness of trial results and impact.
Figure 4.
Figure 4.
Through the TIN Expression of Interest (EOI) investigative teams can leverage a data-driven approach to inform study design and assist with site selection.
See this image and copyright information in PMC

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