Professor Joshua Hordern

BACKGROUND: Trials have become bigger and more complicated due to the complexity introduced by biomarker stratification, and the advent of multi-arm multi-stage trials, and umbrella and basket platform designs. The trials unit at University College London has been at the forefront of this work, with ground-breaking trials such as STAMPEDE and FOCUS4. The trial management and data management teams on these trials have summarised the operational challenges, to enable the broader clinical trials community to learn from their experiences. In a small-scale qualitative study, we examined the personal experience of individual researchers working on these trials. COMMENTARY: We found reports of high workloads, with potentially significant stress for individuals and with an impact on their career choices. We conclude that there was an initial underestimation of the work required and of the inherent, largely unanticipated, challenges. We discuss the importance of fully understanding these trials' resource requirements, both for those writing grant applications and critically, for those with responsibility for deciding on funding. The working environment was characterised by three features: complexity, scale and heightened expectations. These features are highly attractive for professional development and engender high levels of loyalty and commitment. We observed a trade-off between these intrinsic rewards and the continuous demands of overlapping tasks, balancing a mix of routine and high-profile work, and the changing nature of pivotal roles. Such demands present challenges for colleague relationships, by enhancing the potential for competition and by disrupting the natural opportunities to pause, review and celebrate team achievements. In addition, molecular stratification in effect brings the patient into the trial office, as a specific individual, despite anonymisation, who is owed test results and a treatment decision. We discuss these observations with a view to interconnecting the need for compassion for patients with caring for the researchers engaged in the research ecosystem who are aiming to produce much hoped-for advances in medical science. CONCLUSIONS: There is a need for increased awareness of the challenge these studies place on those throughout the team delivering the study. Such considerations must influence leaders and funders, both in their initial budget considerations and throughout delivery.

Thinking about compassion helps to illumine what is pernicious and what is beneficial about an emphasis on personal responsibility for health. This article considers whether it is compatible with compassion to conceive of someone’s disease as a consequence and embodiment of past faults and poor decisions. Two traditions, one Aristotelian and tragedic and the other Thomist and merciful, yield two ideas of compassion. It is argued that disease should not be conceived as something for which one is responsible in a way which puts at risk the possibility of receiving treatment. Even if there is the possibility of not receiving treatment, the past moral responsibility of the agent is not thought the decisive factor but rather the likely benefit to the patient who is perhaps ‘non-cooperative’ or ‘unwilling’ to care for themselves. As regards present-day healthcare, this leads to an affirmation both of preventive medicine as a moral endeavor and of the pastoral care of the sick, with discretion as to the manner and timing of any focus on responsibility.

The marketisation of Western healthcare systems has now proceeded well into its fourth decade. In continental Europe health services have been marketised by way of administrative reform; in England the 2012 Health and Social Care Act was widely perceived as another watershed moment in this process; and in the US the Affordable Care Act is again under critical scrutiny. For those who are critical of further marketisation, the battle has been either adjourned to future legislative periods or escalated into industrial action. Meanwhile, citizens’ critique is undergoing its own kind of marketisation as the ‘patient voice’ of ‘consumer-patients’, audible in both social media and government policy, often replaces older, local forms of representative citizens’ action. In this context the healthcare professions are facing various threats: the marketisation of the profession (everything is a “trade”), managerialisation (good professionalism as the excellent fulfilment of targets) and pluralisation (a profession is what you “make of it”). “Ethics” understood as a discipline dealing with individual, clinical decisions, is no doubt essential to the medical profession and curriculum here. But the discipline has also become separated from political economy and its structures. As one of the chapters will highlight, ethics itself has become a commodity for sale on the healthcare market. All of these developments cohere with and are fuelled by technological advances, digitalisation, and deregulation. Medical innovations such as personalised medicines are significant challenges for public healthcare systems, and some form of marketisation is often part of the response. However, the distinction between what is and what is not a market has become increasingly blurred amidst divergent discourses, policies and institutional structures. Hence the central problematic remains how to discern marketisation as a continuously developing phenomenon and concept that redefines moral formation, structures and action. This volume meets this demand and seeks to understand marketisation in action at three levels: the level of systems, that of concrete policies, and the level of those who make healthcare actually happen: doctors, nurses, therapists, carers and other healthcare workers. How does the market, in its various guises, affect healthcare? In a cross- and interdisciplinary effort we will a) highlight contrary interpretations of ‘marketisation’ on a systemic level, in particular with a view to organisational-ethical formation, b) explore the way it effects policy-making, connecting it to phenomena not usually discussed as a direct result of marketisation but with significant moral implications, and finally c) understand healthcare workers’ predicament in a marketised healthcare system, particularly with a view to identifying routes forward for compassionate care, the most prominent moral and ethical concern. To achieve that, the volume clearly demarcates the current fault lines of the debate, aiming for sharp clarity in a field of ambiguous diversity. At the systemic level, this will be done from the perspectives of business-economics, critical medical philosophy, law and organisational ethics. At the level of policy, the moral significance of marketisation will be illustratively explored through litigation avoidance, and the effect of health-economic encodings such as DRGs. The field of ethics for healthcare workers with regards to marketisation will be explored self-reflectively by looking at medical-ethical education, social and analytical philosophy, and virtue ethics. Each part of the book will follow a distinct format that seeks to unpack conceptually how marketisation works. First, it will juxtapose two divergent approaches. The significance of this juxtaposition will then emerge by looking at concrete examples, whether within the approaches offered or within a further chapter. Finally, a synthesising chapter will constructively summarise and creatively take forward the material covered in each part.

Compassion is an attribute of a person’s affective understanding which seeks shared experience of the world’s ills and some alleviation of those ills’ effects. Compassion is cognitive, participative and alleviative. Compassion alleviates suffering by participating in it. Compassion’s cognitive content is shaped by the circumstances and beliefs of those concerned. Since present-day civic life is plural, primary and community healthcare workers’ compassionate understanding must grasp people’s diverse ways of perceiving health and illness. However, while taking patient perceptions seriously rightly excludes professional paternalism, it does not mean that compassion involves uncritical acquiescence to patient perceptions. What is required is a compassion suited for this ‘secular’ time when ultimate questions about human life and suffering have not been finally answered and in which diverse perceptions meet in sometimes critical conversation. Such conversation takes time. And so a lack of or misuse of time may result in failing to reach the goal of compassion and in doing injustice to some in favour of others. Compassion is not in opposition to justice but rather a constitutive feature of justice’s realisation. If both compassion and justice are to characterise practice, both a supportive organisational ethos and regular personal refreshment are required. Pointing to one rich source of refreshment, the motto of the Royal College of General Practitioners, cum scientia caritas, wisely emphasises the greatest of the three theological virtues, love.