Clinical trials--a brave new partnership?

Thornton, H.

doi:10.1136/jme.20.1.19

Cited by 23 publications

(8 citation statements)

References 5 publications

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“…Eight of the 129 articles stated explicitly that RCTs are necessarily unethical, even when equipoise applies, because allocating treatment by lot is contrary to a patient's need for the advice of his/her physician by diluting the salutary effect of the physician him/herself appearing to know what to do, even in the face of uncertainty (Mike, 1989;Schafer, 1982) or equipoise (Gilbert, 1995;Harrington, 1994;Hellman, 1979;Kassirer, 1983, Thornton, 1994Toynbee, 1996).…”

Section: Uncertainty As Justification For Rctsmentioning

confidence: 99%

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

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Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA web site (see overleaf). NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel and funded as project number 93/41/02. The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for the recommendations for policy contained herein. In particular, policy options in the area of screening will, in England, be considered by the National Screening Committee. This Committee, chaired by the Chief Medical Officer, will take into account the views expressed here, further available evidence and other relevant considerations. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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Section: Uncertainty As Justification For Rctsmentioning

confidence: 99%

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

View full text Add to dashboard Cite

show abstract

“…If the ‘good’ of personal care is to be forgone 13 , then the woman must trust that the researchers truly are in equipoise, that there is no known difference between the proposed treatments or interventions. Some patients will prefer to assume that ‘(My) doctor knows best (about me and my baby)’ and not be happy to enter into a discussion of uncertainty that the issue of informed consent will raise 14 . The two‐patient model of pregnancy disallows the imposition of possible harm on one party for the benefit of another 15 , which has particular relevance in studies on the mode of delivery.…”

Section: Introductionmentioning

confidence: 99%

Withholding consent to participate in clinical trials: decisions of pregnant women

Mohanna¹,

Tuna

1999

BJOG

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Objective To identify factors affecting the decision of pregnant women to withhold their consent to Design A qualitative, cross-sectional, retrospective study using semi-structured interviews with Setting Patients' homes.Participants Eighteen women who had been invited previously to participate in a clinical trial in pregnancy, but who had declined. ResultsThe invitation to participate in a clinical trial when pregnant has different implications for different women, and the meanings they ascribe to the invitation to participate will affect the likelihood of them participating. Apregnant woman may feel the pressure of conflicting duties: a protective duty to the fetus and to be a 'good citizen' when asked to participate in research. The sharing of information during the recruitment phase has a crucial bearing on how the invitation will be received. The design of the trial, the type and style of information available, the manner in which it is conveyed, the timing and process of the invitation and by whom it is made all affect the likelihood of a woman agreeing to take part.By asking for the contribution of these women, this study identified factors that can influence the chances of an individual entering a trial or not. Contextualising and personalising risk is important in the consent process as recruiting women when pregnant can be difficult and hinder research. From these comments recommendations for future research involving pregnant women participate in a clinical trial. thematic content analysis. Conclusionhave been drawn up.

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“…4,7,[10][11][12]37,45,[57][58][59][60] Finally there is some evidence that the lay public (especially patients) are unhappy about randomisation; and it is interesting whether this reflects a genuine ethical dispute with the scientists or whether it reflects a misunderstanding of the role and methodology of randomised clinical trials. 61 The latter may appear less significant, but we are not sure that it is: it is just this sort of misunderstanding which destroys the authenticity of apparent informed consent.…”

Section: Search Methodsmentioning

confidence: 99%

Implications of socio-cultural contexts for the ethics of clinical trials.

Ashcroft¹,

Chadwick²,

Clark³

et al. 1997

Health Technology Assessment

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NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel (see inside back cover). The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health.

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Clinical trials--a brave new partnership?

Cited by 23 publications

References 5 publications

Ethical issues in the design and conduct of randomised controlled trials.

Ethical issues in the design and conduct of randomised controlled trials.

Withholding consent to participate in clinical trials: decisions of pregnant women

Implications of socio-cultural contexts for the ethics of clinical trials.

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