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Voters may be unable to hold politicians to account if they lack basic information about their representatives' performance. Civil society groups and international donors therefore advocate using voter information campaigns to improve democratic accountability. Yet, are these campaigns effective? Limited replication, measurement heterogeneity, and publication biases may undermine the reliability of published research. We implemented a new approach to cumulative learning, coordinating the design of seven randomized controlled trials to be fielded in six countries by independent research teams. Uncommon for multisite trials in the social sciences, we jointly preregistered a meta-analysis of results in advance of seeing the data. We find no evidence overall that typical, nonpartisan voter information campaigns shape voter behavior, although exploratory and subgroup analyses suggest conditions under which informational campaigns could be more effective. Such null estimated effects are too seldom published, yet they can be critical for scientific progress and cumulative, policy-relevant learning.

Voters may be unable to hold politicians to account if they lack basic information about their representatives' performance. Civil society groups and international donors therefore advocate using voter information campaigns to improve democratic accountability. Yet, are these campaigns effective? Limited replication, measurement heterogeneity, and publication biases may undermine the reliability of published research. We implemented a new approach to cumulative learning, coordinating the design of seven randomized controlled trials to be fielded in six countries by independent research teams. Uncommon for multisite trials in the social sciences, we jointly preregistered a meta-analysis of results in advance of seeing the data. We find no evidence overall that typical, nonpartisan voter information campaigns shape voter behavior, although exploratory and subgroup analyses suggest conditions under which informational campaigns could be more effective. Such null estimated effects are too seldom published, yet they can be critical for scientific progress and cumulative, policy-relevant learning.

BackgroundPlastic filters on cigarette butts are a widespread source of nonbiodegradable, toxic environmental waste. State and local legislation to ban the sale of single-use cigarettes may be considered to prevent this waste, but scientific evidence on the impact of switching smokers to unfiltered cigarettes on smoking behavior and toxicant exposures is needed to inform this policy. We have designed an open-label, randomized, 9-week, crossover clinical trial of adult filtered-cigarette smokers who switch to unfiltered cigarettes.ObjectiveOur objective is to understand the impact of switching smokers of filtered cigarettes to unfiltered cigarettes on smoking behavior and toxic exposures.MethodsThis trial involves a 1-week baseline period; a 2-week period of smoking filtered or unfiltered cigarettes, where groups are randomly assigned; a 3-week washout period; another 1-week baseline period; and a 2-week crossover period of smoking the opposite condition (ie, filtered or unfiltered cigarettes) for a sufficient sample size of 40 participants. We will determine changes in (1) observed topography (ie, puff count, interpuff interval, and puff volume) and cigarettes smoked per day, via butt counts and self-report, (2) expired carbon monoxide and excretion of urinary cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, and volatile organic compounds, and (3) participants' knowledge and attitudes toward unfiltered cigarettes, satisfaction with smoking, and intention to quit if they were not able to smoke filtered cigarettes.ResultsThis study was funded in June 2018 and approved by the relevant Institutional Review Boards in July 2018. This study has enrolled 37 participants as of October 2020. Data analysis is currently underway, and trial results are expected to be published in spring 2021.ConclusionsThis pilot proof-of-principle study will inform the design of a larger, future research project that can provide robust scientific evidence on our research question. Such a large study could inform possible state or ...

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Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new technologies. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.

Innovation in clinical trials in brain health: Computerised assessment and remote clinical trials
New clinical trials in brain health require innovative methodologies for targeted recruitment and longitudinal assessment. Professor Anne Corbett outlines how her team's PROTECT portfolio can overcome challenges in trials of cognitive health interventions, offering solutions for intelligent trial design. After decades of relative inactivity, there is currently a growing interest and investment in novel interventions for cognitive and mental health conditions. This is particularly true for trials in cognitive impairment and early dementia. This health area has previously been considered too high-risk and challenging, with failed trials and difficulty in recruiting target groups leading to widespread demotivation for trials in this area. However, a new generation of disease-modifying treatments for Alzheimer's Disease is in the pipeline, with immunotherapy lecanemab receiving FDA approval in 2023 and donanemab currently under review. (1) These successes have reinvigorated development in Alzheimer's and dementia drug discovery programmes, and larger numbers of trials are anticipated in the coming years.

Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new technologies. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.

The central issue before Congress wit respect to clinical trial reporting and publication is how to balance the potential beneficial public health effects of requiring that clinical trial data be made public with the burdens that such requirements may place on companies and their own innovation.

The recent focus on public access to pediatric clinical trial data for certain selective serotonin reuptake inhibitors and other antidepressants has highlighted the issues surrounding public access to clinical trial data generally. This report contains information on recent events regarding this issue.

In 2004, concerns arose that certain antidepressants, other medicines, and medical devices, had been marketed to consumers despite unresolved safety issues. Data from clinical trials conducted both before and after a product goes to market are central to assessing its safety and effectiveness, but there is currently no centralized system for reporting results. This report includes information on recent events as related to clinical trial reporting as of the writing of this report and legislation introduced on the subject in the 108th Congress.

There is a growing awareness that research in primary care is needed to provide excellent clinical and population-based care, to develop effective health systems and policies, and to educate future primary care professionals and researchers. The relevance of research undertaken in primary care is unquestionable: the results of researches conducted in other settings has limited relevance because primary care encounters health problems rarely managed in other sectors of health care (i.e. low probability of major acute disease and high prevalence of comorbidity). From legislative aspects to limits and difficulties of application, the article underlines the importance of research in primary care in the Italian context, where this kind of activity is almost absent. An example, concerning the Genova ASL 3, is reported to suggest strategies to promote and improve research as an integral component of family doctors skills.

The randomized clinical trial framework has proven to be a robust way of evaluating and comparing medications and procedures for many years. The promise of measured and unmeasured balance and equipoise through randomization remains very appealing. Emerging challenges for trialists have been diminishing returns in terms of effect sizes as treatments become more effective and the ever-growing costs associated with the operation of clinical trials.
The costs and operational overhead limit the ability of publicly funded trials to operate at a sufficiently robust level. Recently we have been working to engage clinicians and patients in pragmatic clinical trials which in part leverage routinely collected health system data to both provide an unbiased and effective means of obtaining high quality data for recruiting, randomization and outcomes.
As these trials have expanded between provincial jurisdictions, we have had to look for creative solutions to assembling and sharing data in order to reach the trial goals. This presentation will examine some of the technical and logistical challenges that we have faced, how they have been addressed and the path forward for clinical trials.