Thomas John

Many claim that political deliberation has become exceedingly affective, and hence, destabilizing. The authors of this book revisit that assumption. While recognizing that significant changes are occurring, these authors also point out the limitations of turning to contemporary democratic theory to understand and unpack these shifts. They propose, instead, to reframe this debate by deploying the analytic framework of _affective societies_, which highlights how affect and emotion are present in all aspects of the social. What changes over time and place are the modes and calibrations of affective and emotional registers. With this line of thinking, the authors are able to gesture towards a new outline of the political.

Conduct of clinical research involving single patient subjects has a relatively long history. The notion of ‘N-of-1 trials’ first emerged in the 1980s, introducing a method for evaluating the impact of alternately exposing individuals ‘on’ and ‘off’ a particular treatment. In the years since, interest in conventional, randomised, ‘N-of-1 trials’ has fluctuated, though recent advancements in data science, remote monitoring technologies and, more broadly, the ‘personalised’ medicine era has seen renewed engagement with the methodology. Amongst patient cohorts with cancer conduct of such trials has, for the most part, been uncommon, given the methodology is best suited to study of chronic, stable conditions. In recent years however, there has been growing attention within oncology research communities to the idea of ‘N-of-1 trials’. In part, this has been driven by the need to accommodate increasingly granular levels of molecular heterogeneity in cancer research. However, use of the label ‘N-of-1 trial’ has been applied to a variety of research endeavours involving single participants, with varying resemblance to conventional definitions of an ‘N-of-1 trial’. In this paper we review recent cases in which the term ‘N-of-1 trial’ has been operationalised in relation to clinical research amongst adult cancer populations. We then consider both the epistemic and ethical implications of individual-patient research endeavours in oncology. We conclude by noting the phenomenon represents a new frontier for those engaged in ethical oversight, as well as other stake-holders in cancer clinical research, including clinicians, researchers and health-care consumers.

Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade‐offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the ‘therapeutic misconception’. The evolution of the clinical trials landscape, including greater integration of clinical trials into healthcare and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience. Using cancer clinical trials as an exemplar, we describe how methodological changes in early‐ and late‐phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re‐examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation.