Generating comparative evidence on new drugs and devices after approval

This paper reviews some of the current challenges of post-marketing research and discusses the potential for generation of comparative evidence in the post-marketing period and its coordination with pre-approval research efforts.

SPS commentary:

This paper is the second in a series describing and highlighting some fundamental principles related to developing comparative data on drugs and devices, particularly if multiple options exist to treat the same condition.

The first article examines the availability of comparative effectiveness data, and outlines how the current regulatory approaches to approving new medicines and devices address the evidence needs of patients, clinicians, and other decision makers in health systems.


The Lancet

Resource links:

First article