The increasing monkeypox pandemic has raised many
challenges for ongoing clinical trials. These challenges may lead
to difficulties in meeting protocol-specified procedures, including
administering or using the investigational product or adhering to
protocol-mandated visits and laboratory testing. Thus, study drug
interruptions to clinical trial procedures could be less common and
shorter in duration and missed results from patient attendances
could be more common. These difficulties were investigated
by [1] using 18 ongoing trials. The intent of these analyses has
always been to determine whether there were any important
imbalances between treatment groups favoring a study drug, and
treatment groups omitted from the clinical trials due to active
symptoms, hence whether the results could be suggestive of a
causal relationship [2]. Because they lack a control arm, events
associated with COVID-19 (e.g., fever, cough) or events associated
with physical/social isolation or economic hardships might appear
at a more frequent rate.