March 4, 2016

Relative efficacy assesment with mixed treatment comparison

Assessing the relative efficacy of new drugs: an emerging opportunity

"For the majority of new drugs, critical realtive efficacy information is lacking". A strong statement from an article written by EMA officials and a Harvard professor. The article makes two proposals to solve this conundrum:
  • One is observational studies, which are comparatively low cost and reflect routine care, as they often involve retrospectively analysing existing data from patient registries, electronic health records or claims databases. By definition, however, they lack randomization and rely on data that are generated in routine care to assess patients’ health states, and on clinical end points that are prone to misclassification or incompleteness
  • Mixed treatment comparison (MTC) indirectly assess the relative efficacy of two treatments, A and B, by using existing data from two or more RCTs that have compared each of the treatments to a common comparator (for example, one study comparing A versus placebo and another comparing B versus placebo, although there are more-complex MTC designs, including any available head-to-head RCTs). MTCs are fast and inexpensive as they rely on existing RCT data, some of which is produced even before a drug is marketed
A key requirement for successful mixed treatment comparison should be common end point definitions across RCTs. The article explains the promising COMET initiative, and I wonder why this wasn't created before.

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