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Invisible work, actors, and knowledge: An analysis of a clinical trial for a vaccine to stop smoking

Abstract

Experimental vaccines to treat smoking are tested in randomised clinical trials (RCTs) where participants receive real or placebo ‘nicotine vaccination’ plus additional support. RCTs are a standard method within the current conventions of evidence-based medicine. As yet, nicotine vaccines did not ‘work’ better than placebos. Interestingly, several trials showed high overall quit smoking rates. Understanding lifestyle change, scholars argue, requires insights into sociocultural context and embodied experiences. The question then arises how knowledge claims about behaviour change are made in the controlled setting of a clinical trial. Drawing from science and workplace studies, this paper analyses the case of a nicotine vaccination trial. With document analysis, fieldwork and 77 interviews we compared the daily practice of fact-making with the knowledge claims as represented front stage. Our qualitative study suggests that staff and volunteers performed much work in attending to social processes of behaviour change and trial participation. These efforts were underrepresented in the protocol-centred format of trial reports. The knowledge work of assistants in particular was largely absent in official documents. Accounting for experiments with nicotine and other lifestyle vaccines will require an integrative trial design that combines the biomedical rationale with perspectives from the humanities and social sciences.

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Acknowledgements

We thank the interviewed research assistants, researchers, research participants, and their relatives for being kind enough to have shared with us their experiences and views on testing nicotine vaccination in a clinical trial.

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Correspondence to Anna Wolters.

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Competing interests—intellectual or financial—in the research detailed in the manuscript: Anna Wolters: none. Guido de Wert: none. Onno van Schayck has received unrestricted grants for research funding from Pfizer, Boehringer Ingelheim, and Nabi. Klasien Horstman: none.

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This is to confirm that the manuscript comprises original material that is not under review elsewhere and that the study on which this research is based has received ethical approval from the Netherlands Central Committee for Research involving Human Subjects (CCMO).

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Wolters, A., de Wert, G., van Schayck, O.C.P. et al. Invisible work, actors, and knowledge: An analysis of a clinical trial for a vaccine to stop smoking. BioSocieties 15, 1–27 (2020). https://doi.org/10.1057/s41292-018-0136-x

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Keywords

  • Lifestyle vaccination
  • Invisible work
  • Research assistants
  • Knowledge claims
  • Health behaviour change
  • Clinical trial design