New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

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.

Public health practitioners face challenging, potentially high-consequence, problems that require computational support. Available computational tools may not adequately fit these problems, thus forcing practitioners to rely on qualitative estimates when making critical decisions. Scientists at the Center for Computational Epidemiology and Response Analysis and practitioners from the Texas Department of State Health Services (TXDSHS) have established a participatory development cycle where public health practitioners work closely with academia to foster the development of data-driven solutions for specific public health problems and to translate these solutions to practice. Tools developed through this cycle have been deployed at TXDSHS offices where they have been used to refine and enhance the region’s medical countermeasure distribution and dispensing capabilities. Consequently, TXDSHS practitioners planning for a 49-county region in North Texas have achieved a 29% reduction in the number of points of dispensing required to complete dispensing to the region within time limitations. Further, an entire receiving, staging, and storing site has been removed from regional plans, thus freeing limited resources (eg, personnel, security, and infrastructure) for other uses. In 2018, planners from Southeast Texas began using these tools to plan for a multi-county, full-scale exercise which was scheduled to be conducted in October 2019.