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J Clin Endocrinol Metab ; 106(12): e4887-e4902, 2021 11 19.
Article in English | MEDLINE | ID: covidwho-1175358


Unacceptable healthcare disparities in endocrine disease have persisted for decades, and 2021 presents a difficult evolving environment. The COVID-19 pandemic has highlighted the gross structural inequities that drive health disparities, and antiracism demonstrations remind us that the struggle for human rights continues. Increased public awareness and discussion of disparities present an urgent opportunity to advance health equity. However, it is more complicated to change the behavior of individuals and reform systems because societies are polarized into different factions that increasingly believe, accept, and live different realities. To reduce health disparities, clinicians must (1) truly commit to advancing health equity and intentionally act to reduce health disparities; (2) create a culture of equity by looking inwards for personal bias and outwards for the systemic biases built into their everyday work processes; (3) implement practical individual, organizational, and community interventions that address the root causes of the disparities; and (4) consider their roles in addressing social determinants of health and influencing healthcare payment policy to advance health equity. To care for diverse populations in 2021, clinicians must have self-insight and true understanding of heterogeneous patients, knowledge of evidence-based interventions, ability to adapt messaging and approaches, and facility with systems change and advocacy. Advancing health equity requires both science and art; evidence-based roadmaps and stories that guide the journey to better outcomes, judgment that informs how to change the behavior of patients, providers, communities, organizations, and policymakers, and passion and a moral mission to serve humanity.

COVID-19/mortality , Endocrine System Diseases/therapy , Healthcare Disparities , Patient Care , Racism , Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Biomedical Research/organization & administration , Biomedical Research/statistics & numerical data , COVID-19/psychology , Endocrine System Diseases/epidemiology , Endocrine System Diseases/mortality , Health Equity/organization & administration , Health Equity/trends , Health Policy/legislation & jurisprudence , Health Policy/trends , Healthcare Disparities/organization & administration , Healthcare Disparities/trends , Humans , Pandemics , Patient Care/ethics , Patient Care/standards , Patient Care/trends , Racism/prevention & control , Racism/trends , SARS-CoV-2
Cancer Discov ; 11(3): 527-528, 2021 03.
Article in English | MEDLINE | ID: covidwho-1119343


As vice president, Joe Biden was the cancer advocate-in-chief. As president, he has a different public health crisis to deal with-COVID-19-but given Biden's passion for cancer research, many expect he will build on the previous Moonshot initiative with another push to accelerate the pace of progress in cancer control.

Biomedical Research/economics , Biomedical Research/legislation & jurisprudence , Health Policy , Neoplasms/epidemiology , Neoplasms/therapy , Politics , COVID-19/economics , Financing, Government , Government Programs/organization & administration , Humans , Organizational Objectives , Pandemics , Research Support as Topic , United States
Cancer Discov ; 11(3): 524, 2021 03.
Article in English | MEDLINE | ID: covidwho-1040977


The federal spending bill enacted by the U.S. Congress in December for fiscal year 2021 totals $1.4 trillion, plus another $900 billion in emergency COVID-19 relief funding. The $1.4 trillion includes budget increases for the NIH, NCI, and FDA that help the agencies keep pace with inflation. Research advocates say more than $10 billion in emergency supplemental funds for the NIH is urgently needed to support medical research affected by the COVID-19 pandemic.

Biomedical Research/legislation & jurisprudence , Federal Government , Health Policy , Neoplasms/therapy , Research Support as Topic , Biomedical Research/economics , COVID-19/economics , COVID-19 Vaccines/economics , Humans , Medical Oncology/organization & administration , National Cancer Institute (U.S.)/economics , National Institutes of Health (U.S.)/economics , Neoplasms/economics , Societies, Medical , United States , United States Food and Drug Administration/economics
Cancer Immunol Res ; 9(3): 261-264, 2021 03.
Article in English | MEDLINE | ID: covidwho-1033549


The immunomodulatory effects of immune-checkpoint blockade (ICB) therapy for cancer may act at the crossroads between the need to increase antiviral immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to decrease the inflammatory responses in severe cases of coronavirus disease 2019 (COVID-19). There is evidence from preclinical models that blocking programmed death receptor 1 (PD1) protects against RNA virus infections, which suggests that patients with cancer receiving ICB may have lower rates of viral infection. However, given the heterogeneity of patient characteristics, this would be difficult to demonstrate using population-based registries or in clinical trials. Most studies of the impact of ICB therapy on the course of COVID-19 have centered on studying its potential detrimental impact on the course of the COVID-19 infection, in particular on the development of the most severe inflammatory complications. This is a logical concern as it is becoming clear that complications of COVID-19 such as severe respiratory distress syndrome are related to interferon signaling, which is the pathway that leads to expression of the PD1 ligand PD-L1. Therefore, PD1/PD-L1 ICB could potentially increase inflammatory processes, worsening the disease course for patients. However, review of the current evidence does not support the notion that ICB therapy worsens complications from COVID-19, and we conclude that it supports the continued use of ICB therapy during the COVID-19 pandemic provided that we now collect data on the effects of such therapy on COVID-19 vaccination.

COVID-19/complications , COVID-19/therapy , Immune Checkpoint Inhibitors/therapeutic use , Neoplasms/therapy , B7-H1 Antigen/metabolism , Biomedical Research/economics , Biomedical Research/legislation & jurisprudence , COVID-19/immunology , COVID-19 Vaccines , Humans , Inflammation , Neoplasms/complications , Neoplasms/immunology , Pandemics , Prognosis , Programmed Cell Death 1 Receptor/metabolism , Signal Transduction
Bull World Health Organ ; 98(9): 625-631, 2020 Sep 01.
Article in English | MEDLINE | ID: covidwho-769114


While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.

Pendant que les gouvernements se concentrent sur les profonds bouleversements que la maladie à coronavirus 2019 (COVID-19) engendre pour l'économie mondiale ainsi que sur l'urgence des recherches qui y sont consacrées, d'autres études sont touchées de plein fouet par la pandémie. Plusieurs travaux de recherche d'importance majeure, sans lien avec la COVID-19, ont considérablement ralenti ou ont été totalement interrompus. Soit en raison des restrictions légales relatives à la COVID-19, soit à cause de problèmes logistiques, opérationnels ou d'effectifs. En ce moment, des milliards de personnes à travers le monde sont soumises à un confinement ou un couvre-feu. Comme la durée de telles mesures restrictives est inconnue et susceptible de changer, de nombreuses études sont actuellement en suspens et le bien-être de dizaines de milliers de participants est menacé. Ces circonstances particulières ont entraîné des défis éthiques complexes, qui requièrent une attention immédiate de la part des promoteurs, chercheurs et organismes de réglementation internationaux. Certains promoteurs et organismes de réglementation ont publié des directives sur la manière de gérer les interruptions de recherches cliniques dues à la COVID-19. Elles offrent un bon point de départ pour négocier les écueils au fil de l'évolution de la pandémie, mais elles ne s'appliquent qu'aux chercheurs financés ou administrés par ces instances. Dans le présent document, nous proposons donc des directives destinées à mieux gérer de telles interruptions, au-delà de ce cadre spécifique. Nous soulignons quelques-uns des effets de la pandémie de COVID-19 sur d'autres projets de recherche en cours qui n'ont aucun rapport avec la maladie, et nous donnons des conseils pratiques sur la manière de garantir le bien-être des participants aux études concernées. Enfin, nous parvenons à la conclusion que les législateurs, promoteurs, chercheurs et organismes de réglementation doivent adopter une approche plus souple, afin d'assurer la sécurité des participants tout en préservant l'intégrité des données et en respectant les bonnes pratiques cliniques.

Mientras que los gobiernos se han centrado en la perturbación sin precedentes de la economía global que la enfermedad del coronavirus 2019 (COVID-19) ha causado y en la urgente necesidad de investigar sobre esta enfermedad, otras investigaciones sanitarias se han convertido en víctimas de la pandemia. Las principales actividades de investigación que no están relacionadas con la COVID-19 se han reducido de manera significativa o se han suspendido por completo debido a las restricciones legales relacionadas con la COVID-19 o a los problemas logísticos, de personal u operativos. En la actualidad, el confinamiento o los toques de queda afectan a miles de millones de personas en todo el mundo. Muchos estudios se encuentran ahora en el limbo y el bienestar de decenas de miles de sus participantes está en peligro debido a que se desconoce el calendario de esas medidas restrictivas y está sujeto a cambios. Estas circunstancias han planteado desafíos éticos complejos que merecen una atención urgente por parte de los patrocinadores, los investigadores y los organismos reguladores internacionales. Algunos patrocinadores y organismos reguladores han publicado pautas sobre cómo se deben gestionar las perturbaciones relacionadas con la COVID-19 en la investigación clínica. Aunque estas pautas constituyen un buen punto de partida para hacer frente a los desafíos de la pandemia que está evolucionando, solo se aplican a los investigadores que son financiados o gestionados por estos organismos. En este documento, se ofrecen pautas para gestionar esas perturbaciones que se extienden más allá de estos entornos específicos. Se resaltan algunos de los efectos de la pandemia de la COVID-19 en otros proyectos de investigación en curso que no están relacionados con esta enfermedad y se proporcionan pautas prácticas sobre cómo se debe gestionar el bienestar de los participantes afectados en el estudio. Se concluye que los responsables de formular las políticas, los patrocinadores, los investigadores y los organismos reguladores deben adoptar un enfoque más flexible para garantizar la seguridad de los participantes, al tiempo que se mantiene la integridad de los datos y se cumplen las buenas prácticas clínicas.

Biomedical Research/economics , Biomedical Research/legislation & jurisprudence , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Betacoronavirus , COVID-19 , Humans , Pandemics , Research Personnel , Research Subjects , SARS-CoV-2