Using Novel Endpoints to Transform Oncology Clinical Trials

Posted by Malik Kaman on Jun 28, 2018 8:00:00 AM

Joshua Hattem and Matt Furlow co-authored this post with Malik Kaman.

To match the rapid changes occurring in cancer therapy development, oncology clinical trials are making a few changes of their own. As contemporary clinical trials break with tradition by infusing new, or different, outcome measures to better assess clinical efficacy, the results are encouraging: Single-arm phase I/II trials are gaining accelerated approvals using overall response rate (ORR) and duration of response (DoR) as proxies for survival and 72% of the oncology treatments reviewed by the FDA since 2006 gained approval based on response rate and progression-free survival endpoints.


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Improving Drug Development: A Call to Action

Posted by Malik Kaman on Nov 9, 2017 9:39:46 AM

Joe Keller, Chris Crabtree and Sarah Jegasothy co-wrote this article with Malik Kaman. 

If you’ve missed the transformation of the oncology therapeutic landscape over the past five years, you’ve had your head in the sand. While many recent advancements are hugely beneficial, one result of this tidal wave of investment is that some new drugs offer only marginal improvements yet command outrageous price tags. This is a controversial issue and should give everyone in oncology pause. 


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Is it Time to Rethink PFS?

Posted by Pranav Srivastava on Oct 30, 2017 10:59:18 AM

Vinod Nair co-wrote this blog post with Pranav Srivastava.

Since the first guidelines on surrogate endpoints came out in 2003—codifying the idea that endpoints like progression-free survival (PFS), time-to-progression (TTP) and objective response rate (ORR) could be used to gain special approval—they’ve become a mainstay in oncology trial designs, with a significant increase in the number of abstracts reporting PFS as an endpoint.


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