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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Beyond PD-L1: In Search of Better Biomarkers

Posted by Sharon Karlsberg on Jul 14, 2017 8:00:00 AM

Tyler Vogt co-wrote this blog post with Sharon Karlsberg. 

Since their first approval in 2014, PD-L1 and PD-1 checkpoint inhibitors have become the backbone therapy in multiple tumor types: melanoma, bladder cancer and non-small-cell lung cancer (NSCLC). Although only 20 to 35% of patients respond to these therapies, approvals in melanoma, bladder cancer and second-line lung cancer didn’t require an associated diagnostic test for PD-L1 status. Until the failure of BMS’s CheckMate-026 trial in first-line NSCLC, oncologists were asking the question, “Should I test for PD-L1?”


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Real-World Evidence Today and Tomorrow: The Role of Key Stakeholders

Posted by Maria Whitman on Jul 13, 2017 10:59:32 AM

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

Thomas Edison said: “There is a way to do it better. Find it.” Real-world evidence is a tool to help us do just that.

The theme at this year’s American Society of Clinical Oncology (ASCO) 2017 Annual Meeting (ASCO) was "Making a Difference in Cancer Care With YOU," which highlights the importance of everyone's involvement in improving care for patients with cancer. This theme also reminds us that improving care is part innovation and part application of what we have to do better.


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Real-World Evidence as a Mechanism for Patient-Centric and Individualized Care

Posted by Maria Whitman on Jul 10, 2017 2:31:47 PM

Mimi Traylor-Knowles contributed to this blog post.

Recently, I sat in the audience of an oncology congress and heard a patient survivor and advocate describe critical transitions in his experience living with cancer: At diagnosis, he went from a “person” to a “patient,” and during clinical trial enrollment, he went from a “patient” to a “subject.” 


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