Dear Colleagues:
FDA issued the Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Final Guidance for Industry.
If you are in the clinical regulatory of generic or 505b(2) or NMEs, you may want glance through this. FDA allows inclusion of covariates in the statistical analyses to increase sensitivity of hypothesis testing. The key is that we have to let the FDA know ahead of the protocol execution in many cases and always needs to be in the SAP before the blind broken. The costly mistake is realizing that some covariates could have been included. Post-hoc is good for lessons learned but not really for study success. The dilemma is how many covariates should we include in multicenter trials if center is included as a variable.
Am sure you must have gone through the exercise on " should we or should we not" include covariates.
Like to hear you comments on this Guidance or your experiences on handling covariates in you clinical trial project.
Please share DOs as well as DoN'ts.
Thanks,
-Raja
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Raja Velagapudi Ph.D.
Sr. Director, Clinical Development
Tolmar Inc
Monmouth Junction NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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