ABSTRACT
The COVID-19 pandemic brought about major changes in cancer clinical trials. In its aftermath, the community has an opportunity to incorporate some of these changes as part of the future of trial conduct to make it more patient centered.
Subject(s)
COVID-19 , Clinical Trials as Topic , Neoplasms , Academies and Institutes , COVID-19/prevention & control , Clinical Trials as Topic/legislation & jurisprudence , Clinical Trials as Topic/organization & administration , Drug Industry , Government Agencies , Humans , Infection Control , National Cancer Institute (U.S.)/organization & administration , United States , United States Food and Drug AdministrationABSTRACT
Five years ago, the Melanoma Research Foundation (MRF) conducted an assessment of the challenges and opportunities facing the melanoma research community and patients with melanoma. Since then, remarkable progress has been made on both the basic and clinical research fronts. However, the incidence, recurrence, and death rates for melanoma remain unacceptably high and significant challenges remain. Hence, the MRF Scientific Advisory Council and Breakthrough Consortium, a group that includes clinicians and scientists, reconvened to facilitate intensive discussions on thematic areas essential to melanoma researchers and patients alike, prevention, detection, diagnosis, metastatic dormancy and progression, response and resistance to targeted and immune-based therapy, and the clinical consequences of COVID-19 for patients with melanoma and providers. These extensive discussions helped to crystalize our understanding of the challenges and opportunities facing the broader melanoma community today. In this report, we discuss the progress made since the last MRF assessment, comment on what remains to be overcome, and offer recommendations for the best path forward.
Subject(s)
COVID-19/prevention & control , Medical Oncology/methods , Melanoma/therapy , Practice Guidelines as Topic , SARS-CoV-2/isolation & purification , Skin Neoplasms/therapy , Biomedical Research/methods , Biomedical Research/trends , COVID-19/epidemiology , COVID-19/virology , Humans , Medical Oncology/organization & administration , Medical Oncology/trends , Melanoma/diagnosis , SARS-CoV-2/physiology , Skin Neoplasms/diagnosisABSTRACT
The relationship between SARS-CoV-2 viral load and risk of disease progression remains largely undefined in coronavirus disease 2019 (COVID-19). Here, we quantify SARS-CoV-2 viral load from participants with a diverse range of COVID-19 disease severity, including those requiring hospitalization, outpatients with mild disease, and individuals with resolved infection. We detected SARS-CoV-2 plasma RNA in 27% of hospitalized participants, and 13% of outpatients diagnosed with COVID-19. Amongst the participants hospitalized with COVID-19, we report that a higher prevalence of detectable SARS-CoV-2 plasma viral load is associated with worse respiratory disease severity, lower absolute lymphocyte counts, and increased markers of inflammation, including C-reactive protein and IL-6. SARS-CoV-2 viral loads, especially plasma viremia, are associated with increased risk of mortality. Our data show that SARS-CoV-2 viral loads may aid in the risk stratification of patients with COVID-19, and therefore its role in disease pathogenesis should be further explored.