Sponsors of trials impacted by the COVID-19 pandemic have several statistical analysis options for mitigating the effect of missing data, according to the FDA.
A guidance issued yesterday notes that multiple strategies may be needed to adequately address the COVID-19 impact, including collecting information on discontinuation of treatment, withdrawal of a patient from the trial, use of alternative or rescue treatments, and missed or alternative endpoint assessments to incorporate into the statistical analysis plan.
Sponsors that consider stopping a trial early and conducting final analysis may perform a blinded power assessment to determine what effect the smaller data pool might have on the validity of statistical conclusions.
It also may be reasonable to exclude patients from the data pool if they were not able to receive the full benefit of the treatment being studied.
Trials also may plan to gather additional data by enrolling additional participants and extending the trial period beyond the end of the pandemic or by extending the patient follow-up period after treatment ends.
Modifications of trial endpoints and statistical analysis plans should be discussed with the FDA, the guidance says.
Read the guidance here: www.fdanews.com/06-17-20-Guidance.pdf. — Suz Redfearn