Generating comparative evidence on new drugs and devices before approval

This paper 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.

SPS commentary:

This paper is the first 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 authors propose strategies to improve the future availability of comparative data at the time of market entry.

The second article 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.


The Lancet

Resource links:

Second article