Distributive Justice and Clinical Trials in the Third World

One of the arguments against conducting human subject trials inthe Third World adopts a distributive justice principle found ina commentary of the CIOM'S Eighth Guideline for internationalresearch on human subjects. Critics argue that non-participantmembers of the community in which the trials are conducted areexploited because sponsoring agencies do not ensure that theproducts developed have been made reasonably available to theseindividuals.I argue that the distributive principle's wording is too vagueand ambiguous to be used to criticize any trial. Furthermore,the mere fact that an experiment does not fulfill this particulardistributive justice principle does not entail that it isunethical.     

美国人类受试者使用的历史

所有关于研究伦理的国际法典及实际中的关于人体受试者研究领域的各国立法及规则都表明了保护主义的姿态,他们的主旨是保护个人不受伤害和剥削。这种保护主义姿态有其重要的历史原因,起草这些文件具有这样的目的;保证像被纳粹医生-研究者犯下的罪行,试验药物Thalidomide引发的灾难及Tuskegee梅毒研究对伦理道德的亵渎永远不会重演,近些年来社会对临床研究的理解已发生了戏剧性转变,如经AIDS积极分子努力的结果,人们已以宽容和有益的心态广泛接受临床试验。虽然这种姿态的转变已产生了在指导进行临床研究方面的政策及实践某些重要的改善,但人们必须认识到,这种新的接受正像先前的过度保护主义一样的错误,其应该维护一个平衡的比例。我们的政策应反映出鼓励符合伦理学的研究的要求,同时要保持必要的防范以保护受试者的权益。     

Does Evidence-Based Medicine Apply to Psychiatry?

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not be the best way to pursue psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs.     

On the effectiveness of including meaningful pictures in the formation of equivalence classes

In three experiments, 165 adult participants were trained on 12 baseline conditional discriminations and tested for the formation of three 5-member equivalence classes (A➔B➔C➔D➔E). All experiments included two reference groups; the abstract (ABS) group was trained with all abstract stimuli and the picture (PIC) group with C-stimuli as meaningful pictorial stimuli but A, B, D, and E stimuli as abstract shapes. In Experiment 1, the color of the meaningful stimuli was manipulated. In the ABS, PIC, and black-and-white groups, 33.3%, 80%, and 93.3% formed equivalence classes, respectively. In Experiment 2, participants were exposed to a test block with and without trials that included C stimuli. For the groups with and without C trials in the test, 93.3% and 86.7% formed equivalence classes, respectively, compared to 20% in the ABS group. In Experiment 3, the number of meaningful pictures and their location in stimulus classes were manipulated. One group was trained with 3 pictures (C1/B2/D3, the 3-PIC) while the other groups had 2 pictures (C1/B2 and C1/D3, the 2-PIC). In the second test block for the ABS and PIC groups, 6.7% and 86% of the participants formed equivalence classes, respectively. For the 3-PIC and the 2-PIC groups, 66.7% and 50% of the participants formed equivalence classes, respectively. Results suggest that the effects of meaningful stimuli in equivalence classes (a) cannot be attributed to the use of colorful stimuli in previous studies, (b) occur during training and are not dependent on the presence of meaningful stimuli at test, and (c) are sensitive to stimulus location.     

Political Screenings as Trials of Strength: Making the Communist Power/lessness Real

In this paper, we discuss the problem of communist power in so called totalitarian regimes. Inspired by strategies of explanation in contemporary science studies and by the ethnomethodological conception of social order, we suggest that the power of communists is not to be taken as an unproblematic source of explanation; rather, we take this power as something that is itself in need of being explained. We study personal narratives on political screenings that took place in Czechoslovakia in 1970 and analyze how the power of communists obtained its strength from ordinary and “unremarkable” interactions between participants. The screenings are interpreted, in the terms of Bruno Latour, as “trials of strength.” We show that it was crucial for all the participants that associations, translations or mobilizations involved in making the regime real, remained partial and multiple, and not exclusive and “total” as is often assumed within dominant discourses on totalitarianism.     

When mixed options are preferred in multiple‐trial decisions

We report three studies showing that in prospective multiple‐trial decisions people often select a mix of sure and risky options over pure bundles of either option. Such a preference is not ‘rational’ because a mixed option cannot be the EV‐maximizing choice. Experiment 1 confirmed a mixed‐option preference for gains but not for losses. Showing a graph of the multiple‐trial outcome distribution reduced but did not eliminate this effect, suggesting that it is not due purely to a failure to aggregate correctly over the multiple trials. Experiment 2 replicated the mixed option preference using a wider range of problems. Experiment 3 compared choices in the trinary choice conditions used in Experiments 1 and 2 with binary choices between pairs of the multiple‐trial sure, mixed, and risky options. In the binary choice condition the mixed option was no longer the modal choice, suggesting that the strong mixed option preference found in the trinary choice conditions is mainly due to a compromise effect. However, the binary choice probabilities did show violations of strong stochastic transitivity in a pattern that suggested a slight bias toward the mixed option. Copyright © 2006 John Wiley & Sons, Ltd.     

From question-behaviour effects in trials to the social psychology of research participation

The ‘question-behaviour effect’ (QBE) has attracted much recent attention within health psychology, where it has also been referred to as the ‘mere measurement’ effect. There are other conceptualisations of similar phenomena in related disciplines. This paper explores the implications of the QBE for the safety of inferences about intervention effectiveness within the context of randomised controlled trials evaluating health behaviour change interventions. It draws attention to poorly understood mechanisms by which bias is introduced with conventional thinking about trial design and analysis. The threat to valid inference on intervention effectiveness posed by the QBE applies even when its effects are small and regardless of the specific content of the QBE. The nature of the resulting bias does not fit well within existing bias classification schemes, such as that proposed by the Cochrane Collaboration. The QBE is one possible consequence of research participation and it is suggested that the social psychology of research participation is very much underdeveloped. Possible future directions for health psychology research in this area are considered.     

Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part

Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand the experiences and motivations of young people who took part in clinical trials. This is a qualitative interview study of 25 young people aged 10–23 who were invited to take part in clinical trials. Interviews were audio or video recorded and analyzed using framework analysis. Young peoples' motivations were both personal benefit and helping others. Both incentives appeared to be more complex than expected. We introduce the terms “network of exchange” and “intergenerational solidarity” to describe these motivations. To improve recruitment, professionals should be more open about research opportunities, provide better information, and give young people feedback after the trial has ended.     

Design of randomized controlled trials: Principles and methods applied to a treatment for early stuttering

The “gold standard” methodology for treatment efficacy research is the randomized controlled trial (RCT), which is used extensively in medical research and in other areas such as psychology. Results from a well designed and conducted RCT, which show a new treatment to be clinically and statistically superior to current standard practice, can lead to a change in clinical practice. This paper presents a tutorial on RCTs, presenting and discussing the following principles and methods: the trial protocol, choice of control treatment, eligibility criteria, random allocation, outcomes and hypotheses, sample size, subject recruitment, analysis by intention to treat, interim analysis, stopping rules, safety data monitoring/trial management, and study documentation. RCTs are a complicated and logistically involved methodology. Hence, prior to the commitment of resources to such a trial in the development of a new treatment, the safety and clinical promise of the new treatment needs to be demonstrated with preliminary studies. Such preliminary studies have been completed for the Lidcombe Program (LP) of early stuttering intervention, and an RCT of that treatment is being conducted at the time of writing. The principles and methods of RCTs are illustrated with reference to that study.

Educational objectives: The reader will understand the design principles and methods of RCTs. The reader will understand the logistics of conducting a RCT of a treatment for early stuttering.