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We reflect on the past 10 months of clinical activity in oncology in the UK during the COVID-19 pandemic and suggest how services can be protected during subsequent waves of infection.
The coronavirus disease 2019 (COVID-19) pandemic has disrupted health care worldwide. Patients with cancer seem to be particularly susceptible to morbidities and mortality from this novel disease. No COVID-19-specific therapy currently seems to offer a survival benefit to this unique patient population. Furthermore, the global effects on routine cancer care will likely be felt for decades to come.
Single-arm phase II trials can provide compelling results that facilitate the approval of a new therapy. Designing and interpreting single-arm studies based on four principles — instinct, comparative analysis, statistical soundness and like-for-like comparisons — can provide indications as to which drugs are most likely to provide improved therapeutic options for patients.
Zanubrutinib was recently granted expedited approval by the USA and Chinese drug regulatory authorities for the treatment of mantle cell lymphoma, thus becoming the first investigational new drug discovered in China to achieve simultaneous development in both countries. Here, we provide an overview of the regulatory processes and considerations of the two health authorities and discuss the pathways of concurrent review and approval.
Early published data on COVID-19 in patients with cancer are being referenced in clinical guidelines, despite methodological flaws that limit the quality of much of this evidence. In the next phase of research in this area, we argue that the quality of observational evidence should be prioritized over speed of publication.
The coronavirus disease 19 (COVID-19) pandemic has become the focus of attention worldwide, and herein we seek to highlight the potential problem of ‘collateral mortality’ from delayed or deferred treatments in patients with cancer. We propose potential solutions to ensure continuity of care in the field of surgical oncology.
Radiotherapy can be safely delivered during the coronavirus disease 2019 (COVID-19) pandemic, often through use of hypofractionated regimens, which minimize the number of visits to treatment centres while also avoiding potentially detrimental delays in the delivery of cancer care.
Health-care services are rapidly transforming their organization and workforce in response to the coronavirus disease 2019 (COVID-19) pandemic. These changes, and a desire to mitigate infection risk, are having profound effects on other vital aspects of care, including the care of patients with cancer. Difficult decisions are being made regarding the prioritization of both active treatments and palliative care, despite limited evidence that cancer is an independent risk factor for infection and mortality.
Informative censoring occurs when progression-free survival is the primary end point of a randomized clinical trial and unequal patient dropout is observed between treatment arms owing to poorer tolerance of experimental treatment. Herein we discuss how informative censoring in the experimental arm before criteria for disease progression are met causes bias towards a positive result.
During the COVID-19 global pandemic, the cancer community faces many difficult questions. We will first discuss safety considerations for patients with cancer requiring treatment in SARS-CoV-2 endemic areas. We will then discuss a general framework for prioritizing cancer care, emphasizing the precautionary principle in decision making.
The FDA has demonstrated a willingness to expedite access to new cancer medicines by using real-world evidence to support regulatory drug approval. In this article, we explore three recent examples of such approvals and the lessons that can be learned from this collective experience.
In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.
