Decentralized clinical trials (DCTs): A few ethical considerations.

Decentralized clinical trials (DCTs) are studies in which the need for patients to physically access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and Contract Research Organizations adopted decentralized techniques during the early phase of the pandemic. The implementation of DCTs relies on the use of digital tools such as e-consent, apps, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, as well as on moving trial activities to the patient's home (e.g., drug delivery) or to local healthcare settings (i.e., community-based diagnosis and care facilities). DCTs adapt to patients' routines, allow patients to participate regardless of where they live by removing logistical barriers, offer better access to the study and the investigational product, and permit the inclusion of more diverse and more representative populations. The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors. The evaluation of Ethics Committees (ECs) is crucial to the process of innovating and digitalizing clinical trials: adequate assessment tools and a suitable regulatory framework are needed for evaluation by ECs. DCTs also raise issues, many of which are of considerable ethical significance. These include the implications for the relationship between patients and healthcare staff, for the social dimension of the patient, for data integrity (at the source, during transmission, in the analysis phase), for personal data protection, and for the possible risks to health and safety. Despite their considerable growth, DCTs have only received little attention from bioethicists. This paper offers a review on some ethical implications and requirements of DCTs in order to encourage further ethical reflection on this rapidly emerging field.

Whose life to save? Scarce resources allocation in the COVID-19 outbreak.

After initially emerging in China, the coronavirus (COVID-19) outbreak has advanced rapidly. The World Health Organization (WHO) has recently declared it a pandemic, with Europe becoming its new epicentre. Italy has so far been the most severely hit European country and demand for critical care in the northern region currently exceeds its supply. This raises significant ethical concerns, among which is the allocation of scarce resources. Professionals are considering the prioritisation of patients most likely to survive over those with remote chances, and this news has triggered an intense debate about the right of every individual to access healthcare. The proposed analysis suggests that the national emergency framework in which prioritisation criteria are currently enforced should not lead us to perceive scarce resources allocation as something new. From an ethical perspective, the novelty of the current emergency is not grounded in the devastating effects of scarce resources allocation, which is rife in recent and present clinical practice. Rather, it has to do with the extraordinarily high number of people who find themselves personally affected by the implications of scarce resources allocation and who suddenly realise that the principle of 'equals should be treated equally' may no longer be applicable. Along with the need to allocate appropriate additional financial resources to support the healthcare system, and thus to mitigate the scarcity of resources, the analysis insists on the relevance of a medical ethics perspective that does not place the burden of care and choice solely on physicians.