Reflections on the opportunities and challenges of applying experience-based co-design (EBCD) to phase 1 clinical trials in oncology.

BACKGROUND: Experience-Based Co-Design (EBCD) is a multi-stage participatory action research process which was developed originally to increase patient involvement in service improvement initiatives. This viewpoint article serves as a reflection on the researchers' experiences, focusing on the application and feasibility of participatory approaches, particularly co-design, in the specific context of early-phase clinical trials. METHODS: We reflect on the opportunities and challenges of applying EBCD in a new context of early-phase clinical trials in oncology where experimental treatments are increasingly perceived as a therapeutic option and, in certain instances, their efficacy may lead to accelerated approval facilitating a swifter integration into standard care. RESULTS: We propose that the opportunity of applying EBCD in such trials lies in improving the delivery of person-centered care, care coordination, and support during the transition from experimental to standard care. Three potential challenges when applying EBCD in early-phase clinical trials are discussed related to: the need for standardization in trial processes; planning EBCD in a context of high uncertainty; and vulnerability of patient populations. CONCLUSION: Integrating EBCD into early-phase oncology trials presents an opportunity to enhance person-centered care and can lead to simultaneous improvements in care processes and therapeutic development. PATIENT OR PUBLIC CONTRIBUTION: This article has been developed with the collaboration of a patient partner who serves on the advisory board of our ongoing EBCD study in early clinical trials.

Vaccinal chronicity: immunotherapy, primary care, and the temporal remaking of lung cancer's patienthood in Cuba.

The Cuban biotechnology industry is producing cancer immunotherapy, in particular, therapeutic vaccines that actively stimulate the immune system to stabilise the tumour. These products aim to transform metastatic malignancies into a chronic disease. Since 2010, this therapeutic concept has been integrated within a public health experiment, consisting of the large distribution of immunotherapies, including in primary healthcare centres, to enhance access and assess its effectiveness on a wider population of patients. Such experimental intervention, consisting of post-marketing clinical trials, has focused only on lung cancer, one of the most widespread and lethal cancers on the island. Combining interviews with ethnographic observations focusing on care performed by professionals, patients, and their relatives, this paper analyses the experience of lung cancer chronicity under this type of immunotherapy in Cuba. It shows how a certain form of continuity is made between prophylactic and therapeutic vaccination to shape a new temporality of cancer care, through the integration within primary care, constant access to biotechnology, and multiple care practices directed to strengthen the immunotherapy's efficacy. If vaccinal chronicity remains fragile due to its experimental dimension and the fact that long-term survivorship is still an exceptional phenomenon, lung cancer patienthood is deeply transformed through a shared effort of the people and the state to provide more stable, meaningful, and inclusive care.

Anthropology of new chronicities: illness experiences under the promise of medical innovation as long-term treatment.

In the introduction to the special issue, Greco and Graber discuss the concept of chronicity and the ways it is used in the contributions to the special issue. Historians have shown that the concept of chronic disease has its origins in policy and has always been fluid and vague; however, the classic literature in sociology and nursing has focused on modelling the evolution of chronic disease rather than on examining the concept itself. In the introduction, chronicity is explored in the ways in which it is transformed by medical innovation. Innovations in biomedicine promise to turn terminal and acute conditions in chronic and to render chronic conditions curable. Even when such promises are not fulfilled, they change the context of the illness and the experiences of patients. In such a context a specific work is required from patients, in terms of adherence to the treatments, but also in terms of pursuing experimental treatments that could make their condition chronic. The introduction offers a critical exploration of the concept of chronicity, highlighting both its fluid definition and the changes linked to medical innovation, and the ways in which it shapes the temporalities and experiences of illness in complex ways that cannot be reduced to simplified schemas and trajectories.