CVOTs vs. Real World Data in Diabetes

Should we combine RCT with RWD.

Double blind randomized control studies are the gold standard to prove both safety and efficacy of a drug. However they have several limitations due to their relatively small size and short duration, which prevent the full ability to insure safety and/or efficacy of a drug on a broad population or specific subgroups.

RDW can solve the issue of size and sometimes also length of follow up, however in spite of propensity matching some known and unknown confounders might have a large influence on both safety and efficacy. Since RCT are very expensive and limited with the number of patients valuable for the study, primary as well as secondary end point might be misleading in spite of blind randomization.

In my presentation I will discuss the shortcomings and advantages of both RCT and RWD and the real way to combine them in order to better learn about the safety and efficacy of new drugs.