There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining (...) 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated. (shrink)

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 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)

The pessimistic induction plays an important role in the contemporary realism/anti-realism debate in philosophy of science. But there is some disagreement about the structure and aim of the argument. And a number of scholars have noted that there is more than one type of PI in the philosophical literature. I review four different versions of the PI. I aim to show that PIs have been appealed to by philosophers of science for a variety of reasons. Even some realists have appealed (...) to a PI. My goal is to advance our understanding of what the various PIs can teach us about science and the threat posed by PIs to scientific realism. (shrink)

This chapter discusses Kuhn’s conception of the history of science by focussing on two respects in which Kuhn is an historicist historian and philosopher of science. I identify two distinct, but related, aspects of historicism in the work of Hegel and show how these are also found in Kuhn’s work. First, Kuhn held tradition to be important for understanding scientific change and that the tradition from which a scientific idea originates must be understood in evaluating that idea. This makes Kuhn (...) a historicist in a sense we may call conservative. Secondly, Kuhn held that there is a pattern to the development of science. In the light of the fact that he held scientific change to be law-like, we can call this second aspect of Kuhn’s historicism determinist. I discuss the relationship of Kuhn’s historicist historiography to the philosophical purposes he had for his history of science, namely to refute a conception of scientific progress as driven towards increasing truth by something like ‘the scientific method’. I argue that while this determinism refutes certain positivist conceptions of scientific change, it also requires internalism—the view that the causes of scientific change come from within science, not from outside. Consequently, Kuhn’s historiography of science contrasts with that implicit in much of post-Kuhnian science studies. (shrink)

The recruitment of respondents belonging to ethnic minorities poses important challenges in social and health research. This paper reflects on the enablers and barriers to recruitment that we encountered in our research work with persons belonging to ethnic minorities. Additionally, we applied the Matching Model of Recruitment, a theoretical framework concerning minority recruitment, to guide our reflection. We also explored its applicability as a research design tool. In assessing our research experience, we learned that minority recruitment in social and health (...) research is influenced by the social context of all key players involved in the research. Also, there are enablers and barriers within that social context facilitating or delaying the recruitment process. The main enablers to recruit respondents belonging to ethnic minorities include working with community agencies and gatekeepers who share a common vision with researchers and the latter’s ability to gain the trust of potential respondents. The main barriers include demanding too much from these same community agencies and gatekeepers and ignoring factors that could delay the completion of the research. Although we found the Matching Model of Recruitment to be an effective tool in assessing the processes of recruiting respondents belonging to ethnic minorities, further empirical research is needed to explore its usefulness during the research planning phase. (shrink)

Book Review K. Brad Wray: Resisting Scientific Realism. Cambridge University Press: Cambridge 2018, xii + 224 pp, £ 75.00 (Hardcover), ISBN: 9781108231633. By Ragnar van der Merwe. In The Journal for the General Philosophy of Science.

Pv~P: Cambridge Journal of Undergraduate Philosophy, Issue 1, 1982.

Festschrift honoring P.F. Strawson; includes contributed articles on his contributions in logic and on logic.

This is a transcript of a conversation between P F Strawson and Gareth Evans in 1973, filmed for The Open University. Under the title 'Truth', Strawson and Evans discuss the question as to whether the distinction between genuinely fact-stating uses of language and other uses can be grounded on a theory of truth, especially a 'thin' notion of truth in the tradition of F P Ramsey.

Frank Plumpton Ramsey (1903-1930), Cambridge mathematician and philosopher, was one of the most brilliant people of his generation. He lived in an extraordinarily stimulating milieu, surrounded by figures such as Russell, Whitehead, Keynes, Moore, and Wittgenstein. Ramsey's highly original papers on the foundations of mathematics, probability, economics, philosophy of science and the theory of knowledge were very influential in the 20th century and are still widely discussed in the 21st.

I argue that van Fraassen's selectionist explanation for the success of science is superior to the realists' explanation. Whereas realists argue that our current theories are successful because they accurately reflect the structure of the world, the selectionist claims that our current theories are successful because unsuccessful theories have been eliminated. I argue that, unlike the explanation proposed by the realist, the selectionist explanation can also account for the failures of once successful theories and the fact that sometimes two competing (...) theories are both equally successful. (shrink)