FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
FDA released its final guidance concerning covariate adjustments in randomized clinical trials on May 30, 2023. The guidance, which applies to randomized, parallel group clinical trials for both drugs and biological products, focuses on the use of prognostic baseline covariates “to improve statistical efficacy for estimating and testing treatment effects,” according to an agency press release.
The guidance does not address use of covariates to control for confounding variables in non-randomized trials, in models to account for missing outcome data, or for analyzing longitudinal repeated measures data. Additionally, the use of Bayesian methods or machine learning methods for covariate adjustment is not addressed.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
