Abigail Burdon
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View article: A randomised-controlled Phase I de-escalation trial of Molnupiravir and Nirmatrelvir/Ritonavir combination for mild-moderate SARS-CoV-2 infection
A randomised-controlled Phase I de-escalation trial of Molnupiravir and Nirmatrelvir/Ritonavir combination for mild-moderate SARS-CoV-2 infection Open
Summary Background The AGILE CST-8 ( NCT04746183 ) Phase I de-escalation trial evaluated the safety and tolerability of combination molnupiravir and nirmatrelvir/ritonavir for mild-moderate COVID-19. Methods Adult out-patients with SARS-Co…
View article: Adaptive enrichment trial designs using joint modelling of longitudinal and time-to-event data
Adaptive enrichment trial designs using joint modelling of longitudinal and time-to-event data Open
Adaptive enrichment allows for pre-defined patient subgroups of interest to be investigated throughout the course of a clinical trial. These designs have gained attention in recent years because of their potential to shorten the trial's du…
View article: Next generation clinical trials: Seamless designs and master protocols
Next generation clinical trials: Seamless designs and master protocols Open
Background: Drug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease areas, this is particularly true for Phase II / III cancer …
View article: Early phase clinical trials in oncology: Realising the potential of seamless designs
Early phase clinical trials in oncology: Realising the potential of seamless designs Open
BACKGROUND: The pharmaceutical industry's productivity has been declining over the last two decades and high attrition rates and reduced regulatory approvals are being seen. The development of oncology drugs is particularly challenging wit…