Diabetes CV Studies Spur Questions On Statistical Methods, Data Integrity
Executive Summary
The need to conduct cardiovascular safety assessments for new type 2 diabetes drugs has raised concerns within FDA and industry about statistical methods, data confidentiality and blinding for CV outcomes studies.
You may also be interested in...
Glycemic Control Not Enough For New Diabetes Drugs, Roche Exec Says
Sponsors must move beyond glycemic control if they want any new therapy for type 2 diabetes to be commercially viable, according to a Roche executive.
Glycemic Control Not Enough For New Diabetes Drugs, Roche Exec Says
Sponsors must move beyond glycemic control if they want any new therapy for type 2 diabetes to be commercially viable, according to a Roche executive.
FDA Plans To Add Specifics To Statistical Part Of Antidiabetics CV Guidance
FDA expects to make changes to its final guidance on evaluating cardiovascular risk for new type 2 diabetes drugs based on the experience gained from sponsors' implementation of the guidance