Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

Involving participants in the design of clinical trials should improve the overall success of a study. For this to occur, streamlined mechanisms are needed to connect the populations potentially impacted by a given study or health topic with research teams in order to inform trial design in a meaningful and timely manner. To address this need, we developed an innovative mechanism called the “ResearchMatch Expert Advice Tool” that quickly obtains volunteer perspectives from populations with specific health conditions or lived experiences using the national recruitment registry, ResearchMatch. This tool does not ask volunteers to participate in the trial but allows for wider community feedback to be gathered and translated into actionable recommendations used to inform the study’s design. We describe early use cases that shaped the current Expert Advice Tool workflow, how results from this tool were incorporated and implemented by studies, and feedback from volunteers and study teams regarding the tool’s usefulness. Additionally, we present a set of lessons learned during the development of the Expert Advice Tool that can be used by other recruitment registries seeking to obtain volunteer feedback on study design and operations.

The need to maintain transport during a pandemic places transport workers at higher risk of infection and can have other effects on health and well-being. The aim of this study was to understand the current state of research on the impact of respiratory diseases on transport workers and to identify any existing evidence-based recommendations that can help mitigate the risks associated with these diseases in the transport industry. A scoping review was undertaken as per PRISMA guidelines. A search was conducted in English-language databases for peer-reviewed research articles. We reviewed research articles published over 20 years (2002–2022). We found 12540 articles, of which 39 deemed relevant, were analysed. The review highlighted the high risk of transport workers’ exposure to respiratory diseases during pandemics, exacerbated by structural inequalities including the significant number holding precarious/non-standard jobs. Increased financial strains led to poorer mental health outcomes and risks of detrimental behaviours for health. Economic measures implemented by governments were found to be insufficient in addressing these issues. The review found that transport is a significant transmission point for pandemics of respiratory diseases, and it suggests some remedies to best meet these challenges.

Environment has long been known to have an impact on the evolution of galaxies, but disentangling its impact from mass evolution requires the careful analysis of statistically significant samples. By implementing cutting-edge visualisation methods to test and validate group-finding algorithms, we utilise a mass-complete sample of galaxies to $z \lt 0.1$ comprised of spectroscopic redshifts from prominent surveys such as the 2-degree Field Galaxy Redshift Survey and the Galaxy and Mass Assembly Survey. Utilising our group finding methods, we find 1 413 galaxy groups made up of 8 990 galaxies corresponding to 36% of galaxies associated with group environments. We also search for close pairs, with separations of $r_\mathrm{sep} \lt 50$ $\text{h}^{-1}\text{kpc}$ and $v_\mathrm{sep} \lt 500 \: \text{km s}^{-1}$ within our sample and further classified them into major ($M_{sec}/M_{prim} \leq$ 0.25) and minor ($M_{sec}/M_{prim} \gt $ 0.25) pairs. To examine the impact of environmental factors, we employ bespoke WISE photometry, which facilitates accurate measurements of stellar mass and star formation rates and hence the best possible description of the variation of galaxy properties as a function of the local environment. Our analysis, employing a derived star-forming main sequence relation, reveals that star-formation (SF) within galaxies are pre-processed as a function of group membership. This is evident from the evolution of the star-forming and quenched population of galaxies. We see an increase in the fraction of quiescent galaxies relative to the field as group membership increases, and this excess of quenched galaxies relative to the field is later quantified through the use of the environmental quenching efficiency ($\varepsilon_{env}$) metric. Within the star-forming population, we observe SF pre-processing with the relative difference in specific star formation rates ($\Delta sSFR$), where we see a net decrease in SF as group membership increases, particularly at larger stellar masses. We again quantify this change within the SF population with our star formation deficiency ($\varepsilon_{SFD}$) metric. Our sample of close pairs at low stellar masses exhibit enhanced star formation efficiencies compared to the field, and at larger stellar mass ranges show large deficiencies. Separating the close pairs into major/minors and primary/secondaries reveals SF enhancements projected separation decreases within the minor pairs, this effect is even more pronounced within minor primaries. This research emphasises the importance of carefully studying the properties of galaxies within group environments to better understand the pre-processing of SF within galaxies. Our results show that the small-scale environments of galaxies influence star-forming properties even when stellar masses are kept constant. This demonstrates that galaxies do not evolve in isolation over cosmic time but are shaped by a complex interaction between their internal dynamics and external influences.

Educational opportunities for investigators and staff to promote inclusive research practices are a critical piece of the effort to increase diversity in study participation and promote health equity. However, few trainings to date have empirically been shown to result in behavior changes. We present preliminary evaluation findings for the Just Research workshop offered at the University of Wisconsin–Madison between October 2022 and August 2023. These sessions included 80 participants who made up 4 cohorts. Data was collected through a retrospective pre/post-test survey administered 0–7 days following the workshop (n = 70), and a follow-up survey administered 9–12 months following the workshop (n = 21). Participants demonstrate significant increases in knowledge and self-efficacy regarding implementing inclusive practices post-intervention (p < .001). 85.7% of participants who completed the follow-up survey reported implementing inclusive practices.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study’s recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

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.