IMPORTANCEAn evidence-practice gap exists for cancer pain management, and cancer pain remains prevalent and disabling. OBJECTIVES To evaluate the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services. DESIGN, SETTING, AND PARTICIPANTS A pragmatic, stepped wedge, cluster-randomized, nonblinded, clinical trial was conducted between 2014 and 2019. The clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics. Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS).

Once it has been determined that aggressive medical treatment can no longer meet the goals of care for a ventilated patient, the process of withdrawing mechanical ventilation begins. This is a challenging clinical situation, drawing on the treating physician's skills including clinical decision making with consideration of the ethical and legal domains of practice, high level communication skills, intensive symptom control for the dying patient, and support for families throughout the episode, including bereavement. Central to the success of this process is recognition and respect for the needs and wishes of the patient and family. This case reports on the withdrawal of mechanical ventilation from a conscious patient in their own home, leading to death, following a prolonged hospital admission.

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This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate ‘post-approval’ changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.

Background: In November 2017, the Victorian Voluntary Assisted Dying (VAD) Act was passed enabling people with a progressive terminal illness to end their life voluntarily. Heated debate abounded including, to some extent within palliative care, which was also challenged with developing processes around the legislation enactment.Aim: In response, the lead author convened a series of meetings of palliative care physicians to: (i) share ideas about preparations being undertaken within services; and (ii) re-establish professional cohesion following the divide that the legislation had presented.Methods: A series of three closed meetings were held between the legislation passage and its implementation, with all Victorian palliative care physicians invited to attend. Meetings were facilitated by an experienced psychiatrist from outside the field.Results: These meetings proved very valuable as physicians collectively sought to define and respond to challenges, simultaneously reflecting on the personal and professional implications for individuals and the field. Key areas raised including gauging institutional 'readiness' for the legislation through staff surveys; the educational role of palliative care staff of the legislation implications; communication skills training; the role (if any) of palliative care in the processes of VAD; and the perceptions of palliative care itself in health services and the community. It was during the processes of discussing challenges and sharing solutions that the attendees appeared to reaffirm their professional interconnections. Conclusion:A description of the key elements of these discussions may be useful to others who may yet face similar circumstances with the introduction of VAD legislation.