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For decades the history of the US Military Tribunals at Nuremberg (NMT) has been eclipsed by the first Nuremberg trial-the International Military Tribunal or IMT. The dominant interpretation-neatly summarized in the ubiquitous formula of \"Subsequent Trials\"-ignores the unique historical and legal character of the NMT trials, which differed significantly from that of their predecessor. The NMT trials marked a decisive shift both in terms of analysis of the Third Reich and conceptualization of international criminal law. This volume is the first comprehensive examination of the NMT and brings together diverse perspectives from the fields of law, history, and political science, exploring the genesis, impact, and legacy of the twelve Military Tribunals held at Nuremberg between 1946 and 1949.

This book provides a comprehensive legal analysis of the twelve war crimes trials held in the American zone of occupation between 1946 and 1949, collectively known as the Nuremberg Military Tribunals (NMTs). The judgments the NMTs produced have played a critical role in the development of international criminal law, particularly in terms of how courts currently understand war crimes, crimes against humanity, and the crime of aggression. The trials are also of tremendous historical importance, because they provide a far more comprehensive picture of Nazi atrocities than their more famous predecessor, the International Military Tribunal at Nuremberg (IMT). The IMT focused exclusively on the ‘major war criminals’ — the Goerings, the Hesses, the Speers. The NMTs, by contrast, prosecuted doctors, lawyers, judges, industrialists, bankers — the private citizens and lower-level functionaries whose willingness to take part in the destruction of millions of innocents manifested what Hannah Arendt famously called ‘the banality of evil’. The book is divided into five sections. The first section traces the evolution of the twelve NMT trials. The second section discusses the law, procedure, and rules of evidence applied by the tribunals, with a focus on the important differences between Law No. 10 and the Nuremberg Charter. The third section, the heart of the book, provides a systematic analysis of the tribunals' jurisprudence. It covers Law No. 10's core crimes — crimes against peace, war crimes, and crimes against humanity — as well as the crimes of conspiracy and membership in a criminal organization. The fourth section then examines the modes of participation and defences that the tribunals recognized. The final section deals with sentencing, the aftermath of the trials, and their historical legacy.

To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, “Does this intervention work under usual conditions?,” whereas explanatory trials are focused on the question, “Can this intervention work under ideal conditions?” Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory. We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically. We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial.

International justice has become a crucial part of the ongoing political debates about the future of shattered societies like Bosnia, Kosovo, Rwanda, Cambodia, and Chile. Why do our governments sometimes display such striking idealism in the face of war crimes and atrocities abroad, and at other times cynically abandon the pursuit of international justice altogether? Why today does justice seem so slow to come for war crimes victims in the Balkans? In this book, Gary Bass offers an unprecedented look at the politics behind international war crimes tribunals, combining analysis with investigative reporting and a broad historical perspective. The Nuremberg trials powerfully demonstrated how effective war crimes tribunals can be. But there have been many other important tribunals that have not been as successful, and which have been largely left out of today's debates about international justice. This timely book brings them in, using primary documents to examine the aftermath of the Napoleonic Wars, World War I, the Armenian genocide, World War II, and the recent wars in the former Yugoslavia. Bass explains that bringing war criminals to justice can be a military ordeal, a source of endless legal frustration, as well as a diplomatic nightmare. The book takes readers behind the scenes to see vividly how leaders like David Lloyd George, Winston Churchill, Franklin Roosevelt, and Bill Clinton have wrestled with these agonizing moral dilemmas. The book asks how law and international politics interact, and how power can be made to serve the cause of justice. Bass brings new archival research to bear on such events as the prosecution of the Armenian genocide, presenting surprising episodes that add to the historical record. His sections on the former Yugoslavia tell--with important new discoveries--the secret story of the politicking behind the prosecution of war crimes in Bosnia, drawing on interviews with senior White House officials, key diplomats, and chief prosecutors at the war crimes tribunal for the former Yugoslavia. Bass concludes that despite the obstacles, legalistic justice for war criminals is nonetheless worth pursuing. His arguments will interest anyone concerned about human rights and the pursuit of idealism in international politics.

In the 1980s and 1990s, North American ethics committees developed, in part, in response to court cases and the desire to keep ethical issues out of the courts. In the last several years, clinical ethicists have been called to testify in court in various contexts, including litigation over gender-affirming medical care in the United States and a case regarding pediatric decision-making in Quebec. This workshop will explore clinical ethicists' roles in courts and how clinical ethicists can be credible expert witnesses. Discussants will explore the concept of a legitimate testimony as a clinical ethicist and the idea that theoretical ethical reasoning can be considered expert testimony. Given the exceptional presence of clinical ethicists in courts in North America, this workshop will present ethicists' experiences in the various phases of litigation including preparing for trial, testifying in deposition and at trial. A multidisciplinary group of discussants will facilitate engagement of participants.

The pragmatic explanatory continuum indicator summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions, and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, which is PRECIS-3. We used Web of Science to identify all publication types citing PRECIS-2, published between May 2015 and July 2023. Citations were eligible if they contained ‘substantive’ suggestions, comments, or criticism of the PRECIS-2 tool. We defined ‘substantive’ as comments explicitly referencing at least one PRECIS-2 domain or a concept directly linked to an existing or newly proposed domain. Two reviewers independently extracted comments, suggestions, and criticisms, noting their implications for the update. These were discussed among authors to achieve consensus on the interpretation of each comment and its implications for PRECIS-3. The search yielded 885 publications, and after full-text review, 89 articles met the inclusion criteria. Comments pertained to new domains, changes in existing domains, or were relevant across several or all domains. Proposed new domains included assessment of the comparator arm and a domain to describe blinding. There were concerns about scoring eligibility and recruitment domains for cluster trials. Suggested areas for improvement across domains included the need for more scoring guidance for explanatory design choices. Published comments recognise PRECIS-2's success in aiding trialists with pragmatic or explanatory design choices. Enhancing its implementation and widespread use will involve adding new domains, refining domain definitions, and addressing overall tool issues. This citation review offers valuable user feedback, pivotal for shaping the upcoming version of the PRECIS tool, PRECIS-3. •The paper summarises user feedback from trialists relating to the pragmatic explanatory continuum indicator summary (PRECIS)-2 design tool and points toward considerations, which may be needed to develop and refine the next version of the tool.•Developers should consider adding assessments of blinding and comparator arm design decisions.•Further detail should be given to guide explanatory approaches to design decisions to address the current imbalance, which favors a more pragmatic approach.•Further consideration and research is needed to supplement these review findings to provide guidance for the use of the PRECIS tool for retrospective assessment of design choices.

Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer \"free\" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden

Randomized noncomparative trials (RNCTs) promise reduced accrual requirements vs randomized controlled comparative trials because RNCTs do not enroll a control group and instead compare outcomes to historical controls or prespecified estimates. We hypothesized that RNCTs often suffer from two methodological concerns: (1) lack of interpretability due to group-specific inferences in nonrandomly selected samples and (2) misinterpretation due to unlicensed between-group comparisons lacking prespecification. The purpose of this study was to characterize RNCTs and the incidence of these two methodological concerns. We queried PubMed and Web of Science on September 14, 2023, to conduct a meta-epidemiological analysis of published RNCTs in any field of medicine. Trial characteristics and the incidence of methodological concerns were manually recorded. We identified 70 RNCTs published from 2002 to 2023. RNCTs have been increasingly published over time (slope = 0.28, 95% CI 0.17–0.39, P < .001). Sixty trials (60/70, 86%) had a lack of interpretability for the primary endpoint due to group-specific inferences. Unlicensed between-group comparisons were present in 36 trials (36/70, 51%), including in the primary conclusion of 31 trials (31/70, 44%), and were accompanied by significance testing in 20 trials (20/70, 29%). Only five (5/70, 7%) trials were found to have neither of these flaws. Although RNCTs are increasingly published over time, the primary analysis of nearly all published RNCTs in the medical literature was unsupported by their fundamental underlying methodological assumptions. RNCTs promise group-specific inference, which they are unable to deliver, and undermine the primary advantage of randomization, which is comparative inference. The ongoing use of the RNCT design in lieu of a traditional randomized controlled comparative trial should therefore be reconsidered.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).