Medical Proofs, Social Experiments

Clinical Trials in Shifting Contexts

Bibliographic Data

ID2266359
AuthorsJenny Donovan (0000-0002-6488-5472, University of Bristol, corresponding author)
Year2011
Volume33
Issue7
Pages1113-1114
Publication date2011-11-01
Open AccessYes
TypeARTICLE
VenueSociology of Health & Illness (JOURNAL)
Journal identifiersISSN: 0141-9889 • E-ISSN: 1467-9566
PublisherWiley (PUBLISHER • GB)
DOI10.1111/j.1467-9566.2011.01416.x
OpenAlexW1642896498
LanguageEN
Citations received12

Will, C. and Moreira, T. ( eds ) Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts . Farnham, Surrey : Ashgate , 2010 £55.00 (hbk ) 198 pp . ISBN: 978-0-7546-7928-8 This volume provides an interesting and detailed overview of key sociological critiques of randomised controlled trials (RCTs) through a set of empirical and carefully located ethnographic investigations within particular RCTs or groups of trials in particular clinical areas. The authors provide a brief but helpful background describing how RCTs have become the dominant design for evaluating the comparative effectiveness of interventions of all sorts across the health sector within the context of evidence-based medicine. While the RCT remains situated at the top of the evidence hierarchy, this volume shows that there are mounting methodological, regulatory and sociological challenges for RCTs and, at the same time, increasing concerns about the accuracy and relevance of the evidence that they produce. In three sections, chapters explore the practice of RCTs, the interpretation of outcomes, and links between clinical research and public health policy. The editors outline three key critiques of RCTs that guide their investigations: (a) Methodological - that while RCTs dominate ‘evidence-based medicine’, there are increasing concerns that methodological limitations threaten the validity of their results (b) Economic - that too many RCTs focus on providing evidence but not ensuring that this is in a form that can enable clear judgements about costs and thus policy decisions (c) Sociological - that qualitative studies have started to identify some serious concerns about how RCTs operate in practice and dominate the agenda for healthcare. The book is particularly interesting when it shows how qualitative research and sociological analysis can expose issues hidden within the workings of RCTs that affect the conduct of the RCT and the interpretation of its results. Three chapters, for example, present detailed narratives about the interpretation of RCT results. The underlying contention of the authors is that the RCTs need to be considered within their social and economic context, and that the (usually simply presented) findings about whether the intervention is effective or not are not sufficient. Timmermans, for example, reports on a placebo controlled RCT of a particular drug for methamphetamine dependency. While the overall finding of the RCT was that the drug did not benefit users and harmed a minority, the qualitative research undertaken showed that psycho-behavioural treatments included in the placebo arm had helped many patients, that staff and some patients gained from the experience of the research, and that a simple RCT testing the effectiveness of a drug alone for such a difficult condition was not the best approach. The chapter by Will describes how company-sponsored RCT results relating to the cardiovascular drugs, statins, were challenged by the journal The Lancet because of the inherent biases in their reporting. Moreira focuses on the struggle that occurred between drug developers, regulators, epidemiologists, clinicians, politicians, patients and the public over the simplistic ruling by NICE that new drugs for dementia were not conventionally cost-effective. Other chapters focus on exposing issues that are usually inaccessible to RCT researchers. Heaven, for example, examines relationships between RCT staff that usually remain invisible. In this pilot RCT, two lifestyle interventions were to be compared with medication for common chronic conditions. The lifestyle interventions comprised training packages for practice nurses, with the assumption that nurses would use these taught skills and specially provided materials in consultations with patients. A training programme was quickly and easily produced, but the trainer encountered unexpected hostility from the nurses, and feedback from patients and nurses indicated that the main elements of the training were not implemented. Qualitative research revealed fundamental differences in the understanding of the clinical reality of the chronic conditions and unexpected conflicts between the professional groups involved causing the study to fail. Another theme running through this volume is the strength and growth of patient activism and public involvement in RCTs, and the complex relationships and negotiations that occur between health professionals, patients, government and industry in different ways across the contexts in which RCTs are undertaken. These relationships have, in turn, required a response from RCTs, some of which have changed to take on board public and patient involvement (see http://www.nihr.ac.uk/awareness/Pages/default.aspx). There are several examples of these relationships and methodological developments in the final section of the book - for example in the integration of clinical and technological factors as well as patient participation in an RCT of screening for osteoporosis (Kelly); resistance of patient groups to guidelines on anti-depressant prescribing (Dehue); and including patient perspectives in an RCT of prostate cancer (Faulkner). This book will likely be of most interest to those undertaking qualitative research within RCTs and familiar with sociological critiques, for whom it will doubtless provide interesting reflections on their own research. There is, however, much to be gained from this book by the designers and organisers of RCTs. The chapters including narratives are most accessible, but most (maybe all) trialists would struggle with the length and depth of sociological analysis and jargon. If the authors could translate their detailed and intricate analyses into more simple narratives, and publish this in trials’ journals, the work could have considerable impact

Clinical trial · Context (archaeology · Political science · Psychiatry · Psychological intervention · Randomized controlled trial · Relevance (law · Social science · Sociology · Healthcare cost, quality, practices · Law · Medicine · Mental Health and Psychiatry · Psychology

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