Newsletter | June 25, 2020

06.25.20 -- Struggling With The Aftermath Of Coronavirus? Optimizing Recovery From COVID-19 Trial Disruptions

 
Completing Trials Disrupted By COVID-19: Strategies And Solutions From Expert Statisticians
 

Statisticians have advised on a number of trials confronting skewed or missing data, unexpected comorbidities, patient recruitment and retention challenges, unanticipated interim looks, updated statistical analysis plans, and a range of other difficulties impeding trial completion. This article summarizes the most common questions asked and outlines strategic solutions provided by statisticians.

Trial Disruptions Due To COVID-19? Adaptive Bayesian Approaches Reveal Promising Possibilities
 

A number of trials have been disrupted by the onslaught of the COVID-19 pandemic. This panel discussion reveals the strategic advantage of using Bayesian methods to resolve several trial challenges such as small sample sizes, flexible designs, missing data, and unpredictable recruitment.

Bayesian Methodologies To Address Clinical Development Challenges For COVID-19 Drugs, Devices, And Biologics
 

The COVID-19 pandemic has elevated the challenge of designing and executing clinical trials within a substantially shortened time frame and with limited data on the course of a newly emerged disease. Adaptive and Bayesian trial designs are very well suited to help address the challenges inherent in COVID-19 trials, and the uncertainty in the required sample size.

Platform Trials, Medical Supply, And Cooperation For COVID-19 Vaccines
 

COVID-19 has brought stakeholders together to seek ingenious new methods for vaccines development. Here James Orbinski, who received the Nobel Prize as the head of Medecins Sans Frontieres joins Trevor Mundel, president of the Bill and Melinda Gates Foundation, Robin Mogg, of the Bill and Melinda Gates Research Institute, and Derek Angus, of REMAP-CAP, to discuss new opportunities for public-private and nonprofit cooperation for vaccine development.

FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic
 

The FDA recently issued a guidance on how the COVID-19 pandemic may affect the conduct of clinical trials. Here are some key messages from the guidance along with some interpretations and recommendations from Cytel to keep clinical trials on track during the pandemic.

EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic
 
On March 20, 2020, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Here is a review of selected elements of the guidance, in addition to interpretations and recommendations from Cytel for advancing clinical trials at this time.