The scope of phase I clinical trials in oncology goes beyond the conventional safety evaluation-only objectives of these trials in other specialties. Rather, most first-in-human cancer trials have therapeutic intent, and efficacy signals observed in phase I trials can drive a go/no-go decision of advancing a new molecule to phase II testing. The complexity of efficacy assessment in the context of a small, heterogenous patient population and a complex study design requires a more liberal perspective compared to later trial phases when looking into efficacy endpoints.
View Article and Find Full Text PDFPurpose: Evidence on the incidence and persistence of post-acute sequelae of COVID-19 (PASC) among children and adolescents is still limited.
Methods: In this retrospective cohort study, 59,339 children and adolescents with laboratory-confirmed COVID-19 in 2020 and 170,940 matched controls were followed until 2021-09-30 using German routine healthcare data. Incidence rate differences (ΔIR) and ratios (IRR) of 96 potential PASC were estimated using Poisson regression.