Why Real-World Evidence Is Important for Real-World Cancer Patients

Posted by Jon Roffman on Jun 24, 2019 9:44:47 AM

“A lot of clinical trials are a bit artificial in that the eligibility criteria are ‘purple and pink polka dot patients,’ [but those patients] really don't exist.”

That was the start of my conversation with Dr. Julie Vose at the 2019 American Society of Clinical Oncology (ASCO) annual meeting, where we sat down to talk about real-world evidence and its importance in oncology. Dr. Vose is a believer in evidence-based medicine, and real-world evidence is an important tool in her arsenal for making treatment decisions at the University of Nebraska Medical Center, where she is the head of hematology and oncology.


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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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Accelerating Real-World Evidence to Advance the Trial Landscape

Posted by Maria Whitman on Jul 19, 2017 9:42:04 AM

Mimi Traylor-Knowles co-wrote this blog post with Maria Whitman.

At the 2017 Annual Society of Clinical Oncology Annual Meeting (ASCO), Dr. Sean Khozin, senior medical officer at the FDA, opened his Saturday session with some trivia: When was the first controlled clinical trial? The answer, which surprised many of my fellow attendees, was 1747, when James Lind held a trial to determine if citrus juice would help control the symptoms of scurvy. Dr. Khozin then showed a timeline to demonstrate the history of controlled clinical trials. He concluded his session with a single but poignant visual: a flat line stretching more than 250 years from then until now. As the world has made historic progress in innovation—from steam locomotives to a man on the moon to the internet and all that we have today—controlled clinical trials have remained largely the same. 


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