Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries (...) were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)
This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (shrink)
This paper distinguishes four major types of futility (physiological, imminent demise, lethal condition, and qualitative) that have been advocated in the literature either in a patient dependent or a patient independent fashion. It proposes five criteria (precision, prospective, social acceptability, significant number, and non-agreement) that any definition of futility must satisfy if it is to serve as the basis for unilaterally limiting futile care. It then argues that none of the definitions that have been advocated meet the criteria, primarily because (...) their proponents have not paid sufficient attention to the problematic nature of the data supporting the use of their definitions. (shrink)
There is a growing interest in comparison of international health care data with the hope that such studies will enable individual systems to learn from other systems. Such comparisons, however, presuppose that there exist common criteria for evaluating health care systems. The main thesis of this paper is that these comparative studies are misleading because they employ inappropriate operationalizations of these criteria because the operarionalizations are based upon mistaken global conceptualizations of the criteria in question. The essay provides a methodological (...) critique of what has been done and sets a new agenda for future research. (shrink)
In this paper, I consider a variety of objections against the covering-law model of scientific explanation, show that Aristotle was already aware of them and had solutions for them, and argue that these solutions are correct. These solutions involve the notions of nonHumean causality and of essential properties. There are a great many familiar objections, both methodological and epistemological, to introducing these concepts into the methodology of science, but I show that these objections are based upon misunderstandings of these concepts.