publication date: Sep. 20, 2019

Real-World Evidence

Challenges to leveraging real-world evidence for FDA approval

Ash Malik

By Ash Malik

Chief Strategy Officer, Life Sciences Division,

Integra Connect


The number of approved cancer therapies continues to rise, with 63 cancer drugs launched within the past five years.

This proliferation of new drugs on the market, coupled with biosimilars getting fast-tracked by the FDA, has resulted in mounting competitive pressures for the biopharma industry. In response, the industry has been eagerly embracing the idea of leveraging real-world evidence as a means to reduce time to market, whether by supporting the repurposing of existing drugs for new indications or for post-approval studies.

That said, to justify new drug indications or support phase IV post-approval studies, the industry will be expected to amass large scales of high-quality clinical data while adopting a sophisticated approach to ensuring RWE is truly comparing apples to apples.


A new era of cancer drug development

The 21st Century Cures Act, which was signed into law in December 2016, directed the FDA to develop new programs that would accelerate new drug developments and facilitate bringing new innovations to market, faster and more efficiently.

As part of these ongoing efforts, in December 2018, the FDA announced a new framework specifying how … Continue reading Challenges to leveraging real-world evidence for FDA approval

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