Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations. When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…
FAQ: What is a network meta-analysis (NMA)?
A network meta-analysis (NMA), a method for comparing multiple therapies within a single analysis, uses direct and indirect evidence within a network of randomized controlled studies. An NMA is a type of meta-analysis, which itself is a research technique used to statistically analyze the findings of independent studies. An NMA is thus a meta-analysis comparing…
Why emergency authorization of COVID-19 therapies could pose regulatory questions
Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications. “I’m nervous about the prospect of there never being a COVID vaccine that meets the…