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Background Clinical trial registries have been a priority topic in the past few years in promoting data transparency and accountability. In this context, in 2011, the IRCCS - Istituto di Ricerche Farmacologiche “Mario Negri” set up a registry to collect data on all studies in which the institute’s researchers are involved. In this study we present a self-audit in order to detect the lead researchers’ general knowledge on registries, the completeness and quality of the randomized controlled trial (RCT) data inputted in an Italian research institute’s registry, and the researchers’ adherence to both registration requirements and the institute transparency goal, aiming to improve standards and leading to greater awareness of the issues involved. Methods A questionnaire-based audit was conducted. To interview researchers we included questions ranging from general knowledge on registries (e.g., what are the aims of registries?) to questions about their knowledge of the Mario Negri’s registry, questions on selected trials and registration, included information on the protocol, and the results. Results The audit sample covers 12 of the 47 RCTs at the institute’s Milan branch, representing all the possible lead researchers responsible for RCTs at the institute. The researchers have more than a basic knowledge of trial registries and their aims. All the researchers reported that they know of the ClinicalTrials.gov registry and most of them reported that they frequently use it; however, only a few know about the World Health Organization’s registry platform (International Clinical Trials Registry Platform). The most cited registry aims reported were increased transparency and reduced publication bias. Of the studies registered in the institute’s registry, 92% had at least one data item missing in the registry record. Concerning trial registration in the international registries, all 12 respondents said their trial had been registered and specified the registry name, but often they had not inputted the associated trial ID code in the corresponding field of the institute’s registry. Concerning two important issues on data transparency and ethical standards, namely registration timing and result reporting, 11 stated that their trial was registered before starting recruitment, and for five of six closed trials they stated that their results have been already published—for one trial within 1 year after its completion. Conclusions Researchers should guarantee correct reporting of trials and their data as a rule of great ethical value. Institutional self-audits should be performed periodically in order to improve clinical trial disclosure.

Randomized clinical trials (RCTs) are critical in advancing patient care, yet conducting such large-scale trials requires tremendous resources and coordination. Clinical site start-up performance metrics can provide insight into opportunities for improved trial efficiency but have not been well described. To measure the start-up time needed to reach prespecified milestones across sites in large cardiovascular RCTs in North America and to evaluate how these metrics vary by time and type of regulatory review process. This cohort study evaluated cardiovascular RCTs conducted from July 13, 2004, to February 1, 2017. The RCTs were coordinated by a single academic research organization, the Duke Clinical Research Institute. Nine consecutive trials with completed enrollment and publication of results in their target journal were studied. Data were analyzed from December 4, 2019, to January 11, 2021. Year of trial enrollment initiation (2004-2007 vs 2008-2012) and use of a central vs local institutional review board (IRB). The primary outcome was the median start-up time (from study protocol delivery to first participant enrollment) as compared by trial year and type of IRB used. The median start-up time for the top 10% of sites was also reported. Secondary outcomes included time to site regulatory approval, time to contract execution, and time to site activation. For the 9 RCTs included, the median site start-up time shortened only slightly over time from 267 days (interquartile range [IQR], 185-358 days) for 2004-2007 trials to 237 days (IQR, 162-343 days) for 2008-2012 trials (overall median, 255 days [IQR, 177-350 days]; P < .001). For the top 10% of sites, median start-up time was 107 days (IQR, 95-121 days) for 2004-2007 trials vs 104 days (IQR, 84-118 days) for 2008-2012 trials (overall median, 106 days [IQR, 90-120 days]; P = .04). The median start-up time was shorter among sites using a central IRB (199 days [IQR, 140-292 days]) than those using a local IRB (287 days [IQR, 205-390 days]; P < .001). This cohort study of North American research sites in large cardiovascular RCTs found a duration of nearly 9 months from the time of study protocol delivery to the first participant enrollment; this metric was only slightly shortened during the study period but was reduced to less than 4 months for top-performing sites. These findings suggest that the use of central IRBs has the potential to improve RCT efficiency.

The management of research data is now a major challenge for research organisations. Vast quantities of born-digital data are being produced in a wide variety of forms at a rapid rate in universities. This paper analyses the contribution of academic libraries to research data management (RDM) in the wider institutional context. In particular it: examines the roles and relationships involved in RDM, identifies the main components of an RDM programme, evaluates the major drivers for RDM activities, and analyses the key factors influencing the shape of RDM developments. The study is written from the perspective of library professionals, analysing data from 26 semi-structured interviews of library staff from different UK institutions. This is an early qualitative contribution to the topic complementing existing quantitative and case study approaches. Results show that although libraries are playing a significant role in RDM, there is uncertainty and variation in the relationship with other stakeholders such as IT services and research support offices. Current emphases in RDM programmes are on developments of policies and guidelines, with some early work on technology infrastructures and support services. Drivers for developments include storage, security, quality, compliance, preservation, and sharing with libraries associated most closely with the last three. The paper also highlights a 'jurisdictional' driver in which libraries are claiming a role in this space. A wide range of factors, including governance, resourcing and skills, are identified as influencing ongoing developments. From the analysis, a model is constructed designed to capture the main aspects of an institutional RDM programme. This model helps to clarify the different issues involved in RDM, identifying layers of activity, multiple stakeholders and drivers, and a large number of factors influencing the implementation of any initiative. Institutions may usefully benchmark their activities against the data and model in order to inform ongoing RDM activity.

Engagement with scientific manuscripts is frequently facilitated by Twitter and other social media platforms. As such, the demographics of a paper's social media audience provide a wealth of information about how scholarly research is transmitted, consumed, and interpreted by online communities. By paying attention to public perceptions of their publications, scientists can learn whether their research is stimulating positive scholarly and public thought. They can also become aware of potentially negative patterns of interest from groups that misinterpret their work in harmful ways, either willfully or unintentionally, and devise strategies for altering their messaging to mitigate these impacts. In this study, we collected 331,696 Twitter posts referencing 1,800 highly tweeted bioRxiv preprints and leveraged topic modeling to infer the characteristics of various communities engaging with each preprint on Twitter. We agnostically learned the characteristics of these audience sectors from keywords each user's followers provide in their Twitter biographies. We estimate that 96% of the preprints analyzed are dominated by academic audiences on Twitter, suggesting that social media attention does not always correspond to greater public exposure. We further demonstrate how our audience segmentation method can quantify the level of interest from nonspecialist audience sectors such as mental health advocates, dog lovers, video game developers, vegans, bitcoin investors, conspiracy theorists, journalists, religious groups, and political constituencies. Surprisingly, we also found that 10% of the preprints analyzed have sizable (>5%) audience sectors that are associated with right-wing white nationalist communities. Although none of these preprints appear to intentionally espouse any right-wing extremist messages, cases exist in which extremist appropriation comprises more than 50% of the tweets referencing a given preprint. These results present unique opportunities for improving and contextualizing the public discourse surrounding scientific research.

Purpose Since 2012, PCORI has been funding patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders in the research, a requirement that is unique among the US funders of clinical research. This paper presents PCORI's evaluation framework for assessing the short- and long-term impacts of engagement; describes engagement in PCORI projects (types of stakeholders engaged, when in the research process they are engaged and how they are engaged, contributions of their engagement); and identifies the effects of engagement on study design, processes, and outcomes selection, as reported by both PCORI-funded investigators and patient and other stakeholder research partners. Methods Detailed quantitative and qualitative information collected annually from investigators and their partners was analyzed via descriptive statistics and cross-sectional qualitative content and thematic analysis, and compared against the outcomes expected from the evaluation framework and its underlying conceptual model. Results The data support the role of engaged research partners in refinements to the research questions, selection of interventions to compare, choice of study outcomes and how they are measured, contributions to strategies for recruitment, and ensuring studies are patient-centered. Conclusions The evaluation framework and the underlying conceptual model are supported by results to date. PCORI will continue to assess the effects of engagement as the funded projects progress toward completion, dissemination, and uptake into clinical decision making.

Vivian Cheung sued after her funding was not renewed, alleging discrimination, but the institute said her science no longer met its expectations. Vivian Cheung sued after her funding was not renewed, alleging discrimination, but the institute said her science no longer met its expectations.

International dismay after New Delhi-based Centre for Policy Research funding suspended. International dismay after New Delhi-based Centre for Policy Research funding suspended. Credit: Dasarath Deka/ZUMA Press Wire/Shutterstock Rickshaw puller takes his passengers through the water logged street after rain in Guwahati Assam during monsoon.

As participant-led health research increases, Effy Vayena and and John Tasioulas examine what ethical questions are raised, and what types of standards need to be developed for appropriate ethical oversight for participant-led research projects.

Journals, funders and institutions that employ researchers all want to produce or disseminate rigorous scientific knowledge — and all can learn lessons from misconduct cases. Journals, funders and institutions that employ researchers all want to produce or disseminate rigorous scientific knowledge — and all can learn lessons from misconduct cases.

Childhood and adolescent immunizations compose a valuable public health tool to prevent infection, morbidity, and mortality. The American Academy of Family Physicians recommends that patients receive all recommended immunizations from their usual source of primary care and does not support nonmedical immunization exemptions. Maintaining high vaccination coverage is crucial for preventing outbreaks of vaccine-preventable diseases. Less than 70% of US children have received the full series of recommended vaccinations at 24 months of age. Using electronic health record reminders and creating standing orders to vaccinate according to protocol at every visit can address practice barriers to vaccination. Whereas most routine childhood immunizations have remained the same for the past 10 years, several considerable changes have occurred. With few exceptions, COVID-19 immunizations are recommended annually for all children to prevent disease and hospitalization and to decrease the risk of post–COVID-19 condition. New pneumococcal vaccine formulations that protect against more serotypes are recommended. Pneumococcal vaccination decreases the risk of meningitis, pneumonia, and possibly acute otitis media in children. Either respiratory syncytial virus immunization for the mother between 32 and 36 weeks of gestation from September to January or the monoclonal antibody nirsevimab for the infant from October to March are now recommended for all mother-infant dyads to prevent severe illness.