All Times EDT
Keywords: COVID-19, vaccination, placebo-control, missing data
The late 1980s and the 1990s saw challenges in the design and analysis of studies for regulatory approval of HIV/AIDs antiviral drug products after the first anti-pneumocystis and/or anti-AIDS treatments became available. We seem to be faced with a similar situation but with unique aspects. Following a successful December 10, 2020 meeting by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA, the FDA issued an emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. Subsequently, on December 18, 2020, a second vaccine was granted emergency use authorization in the U.S. for individuals 18 years of age and older. Other candidate vaccines for COVID-19 remain in clinical trials. An important issue that was discussed at the VRBPAC meetings was whether a placebo arm is to be prohibited in planned or ongoing vaccine trials, and under what conditions should assignment to or maintenance of a placebo arm be discontinued. Options considered included crossover, and delayed vaccination.
The challenges for study design and scientific rigor will be addressed in this session. For example, once a vaccine is approved, what will be the impact on acceptable designs for other biologics being investigated for the treatment of Covid19? How are missing data to be handled in such trials when it is likely that patients may leave a study when they become eligible for vaccination?
We aim to discuss this topic in an informal setting