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.

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.

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.

Previously published guidelines have provided comprehensive recommendations for detecting and preventing healthcare-associated infections (HAIs). The intent of this document is to highlight practical recommendations in a concise format designed to assist acute-care hospitals in implementing and prioritizing efforts to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection. This document updates the “Strategies to Prevent Methicillin-Resistant Staphylococcus aureus Transmission and Infection in Acute Care Hospitals” published in 2014.1 This expert guidance document is sponsored by the Society for Healthcare Epidemiology of America (SHEA). It is the product of a collaborative effort led by SHEA, the Infectious Diseases Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of a number of organizations and societies with content expertise.

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.

With the aim of producing a 3D representation of tumors, imaging and molecular annotation of xenografts and tumors (IMAXT) uses a large variety of modalities in order to acquire tumor samples and produce a map of every cell in the tumor and its host environment. With the large volume and variety of data produced in the project, we developed automatic data workflows and analysis pipelines. We introduce a research methodology where scientists connect to a cloud environment to perform analysis close to where data are located, instead of bringing data to their local computers. Here, we present the data and analysis infrastructure, discuss the unique computational challenges and describe the analysis chains developed and deployed to generate molecularly annotated tumor models. Registration is achieved by use of a novel technique involving spherical fiducial marks that are visible in all imaging modalities used within IMAXT. The automatic pipelines are highly optimized and allow to obtain processed datasets several times quicker than current solutions narrowing the gap between data acquisition and scientific exploitation.

Flight crews’ capacity to conduct take-off and landing in near zero visibility conditions has been partially addressed by advanced surveillance and cockpit display technology. This capability is yet to be realised within the context of manoeuvring aircraft within airport terminal areas. In this paper the performance and workload benefits of user-centre designed visual and haptic taxi navigational cues, presented via a head-up display (HUD) and active sidestick, respectively, were evaluated in simulated taxiing trials by 12 professional pilots. In addition, the trials sought to examine pilot acceptance of side stick nose wheel steering. The HUD navigational cues demonstrated a significant task-specific benefit by reducing centreline deviation during turns and the frequency of major taxiway deviations. In parallel, the visual cues reduced self-report workload. Pilot’s appraisal of nose wheel steering by sidestick was positive, and active sidestick cues increased confidence in the multimodal guidance construct. The study presents the first examination of how a multimodal display, combining visual and haptic cues, could support the safety and efficiency in which pilots are able to conduct a taxi navigation task in low-visibility conditions.

The effect of transport on core and peripheral body temperatures and heart rate was assessed in ten 18-month-old Coopworth ewes (Ovis aries) Manual recordings of core (rectal) temperatures were obtained, and automated logging of peripheral (external auditory canal and pinna) temperatures and heart rate was carried out on the day prior to (day 1) and during (day 2) a standardised transport procedure. Transport produced a significant increase in the rectal temperature, which declined following unloading. Peripheral measures of body temperature also exhibited changes with transport. However, both ear-canal and pinna temperatures declined during actual transport, reflecting to some extent the decline in ambient temperatures recorded externally by sensors on the ear tags of the animals. Peripheral measurement of temperature, particularly at the readily accessible ear canal, may offer potential as a technique for the long-term monitoring of thermal responses to stress. However, further research is required into the potentially confounding effects of ambient temperature and wind chill factors.

In Britain large numbers of animals are taken into captivity for treatment or care and then subsequently returned to the wild, but there are few data on the effectiveness of these rehabilitation programmes. In this study, over a period of four years 251 fox cubs that had been captive-reared were tagged and released; 90 were recovered. Survival rates were low, and road traffic accidents were found to be a major cause of mortality immediately following release. Recovery distances were lower than expected. The stress associated with captive-rearing meant that released foxes weighed less than wild-reared foxes, and they suffered further weight loss in the period immediately following release, even though an analysis of the stomach contents of animals recovered dead showed that released foxes rapidly learnt to hunt successfully.

It was concluded that captive-rearing is a problematic process for foxes, and contrary to predictions they face severe problems in adapting following release. Suggestions are made for the improvement of fox captive-rearing and release programmes, and the need for similar studies on other species is highlighted.

The release of animals from captivity frequently leads to a period of erratic movement behaviour which is thought to expose the animal to a high risk of mortality. Twenty-six foxes which had been reared at a wildlife hospital or captive-bred, were radio-collared when nearly full-grown and released without site acclimation. Immediately after release there was an erratic phase of behaviour, during which the foxes travelled widely and movement parameters were markedly elevated. For those foxes which survived, a second phase was entered after an average of 17.2 days, during which one small area only was used, and movement parameters were much reduced. In a second study, nine foxes were released following site acclimation in a pre-release pen; this process postponed but did not eliminate the phase of high movement activity.

This pattern of movement was compared with the dispersal behaviour of wild-reared foxes. It was concluded that released foxes, despite being proficient in other aspects of behaviour, were moving and behaving in a markedly abnormal manner and this resulted in a high death rate. The results are used to discuss methods of improving rehabilitation techniques.

Vaccines serve as a major tool against the coronavirus disease 2019 (COVID-19) pandemic, but vaccine hesitancy remains a major concern in the United States. Healthcare workers (HCWs) strongly influence a patient’s decision to get vaccinated. We evaluated HCW knowledge and attitudes regarding the COVID-19 vaccine.

Metabolites produced by microbial fermentation in the human intestine, especially short-chain fatty acids (SCFAs), are known to play important roles in colonic and systemic health. Our aim here was to advance our understanding of how and why their concentrations and proportions vary between individuals. We have analysed faecal concentrations of microbial fermentation acids from 10 human volunteer studies, involving 163 subjects, conducted at the Rowett Institute, Aberdeen, UK over a 7-year period. In baseline samples, the % butyrate was significantly higher, whilst % iso-butyrate and % iso-valerate were significantly lower, with increasing total SCFA concentration. The decreasing proportions of iso-butyrate and iso-valerate, derived from amino acid fermentation, suggest that fibre intake was mainly responsible for increased SCFA concentrations. We propose that the increase in % butyrate among faecal SCFA is largely driven by a decrease in colonic pH resulting from higher SCFA concentrations. Consistent with this, both total SCFA and % butyrate increased significantly with decreasing pH across five studies for which faecal pH measurements were available. Colonic pH influences butyrate production through altering the stoichiometry of butyrate formation by butyrate-producing species, resulting in increased acetate uptake and butyrate formation, and facilitating increased relative abundance of butyrate-producing species (notably Roseburia and Eubacterium rectale).

The first demonstration of laser action in ruby was made in 1960 by T. H. Maiman of Hughes Research Laboratories, USA. Many laboratories worldwide began the search for lasers using different materials, operating at different wavelengths. In the UK, academia, industry and the central laboratories took up the challenge from the earliest days to develop these systems for a broad range of applications. This historical review looks at the contribution the UK has made to the advancement of the technology, the development of systems and components and their exploitation over the last 60 years.

This SHEA white paper identifies knowledge gaps and challenges in healthcare epidemiology research related to coronavirus disease 2019 (COVID-19) with a focus on core principles of healthcare epidemiology. These gaps, revealed during the worst phases of the COVID-19 pandemic, are described in 10 sections: epidemiology, outbreak investigation, surveillance, isolation precaution practices, personal protective equipment (PPE), environmental contamination and disinfection, drug and supply shortages, antimicrobial stewardship, healthcare personnel (HCP) occupational safety, and return to work policies. Each section highlights three critical healthcare epidemiology research questions with detailed description provided in supplementary materials. This research agenda calls for translational studies from laboratory-based basic science research to well-designed, large-scale studies and health outcomes research. Research gaps and challenges related to nursing homes and social disparities are included. Collaborations across various disciplines, expertise and across diverse geographic locations will be critical.