Should you adjust for covariates when analyzing data from randomized controlled trials?

FDA draft guidance published this month says you should. In most cases, adjusting for covariates is not necessary. Randomization generally insurers that covariates are balanced across clinical trial arms. Randomization, however, may not always result in perfectly balanced trial arms. In these cases, the FDA notes that covariate adjustment is perfectly acceptable. There are some…

Payer coverage of FDA-approved drugs

Many people think that once a treatment is approved, your insurance automatically covers the treatment.  However, that is no longer the case.  Some health plans may keep certain drugs off of formularies.  Others health plans have drugs on formulary but may require step edits (failing another drug first before moving to the novel treatment) and…