Roche Oncology Trials Designed For “Learning On The Go”
Roche is innovating in the structure of clinical development to manage the increasingly complex knowledge of cancer biology, using adaptive trial designs and extensive analysis of responders to find biomarkers that can inform, adjust and enrich clinical studies in a continually iterative process of “learning on the go.”
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Cancer Trial Endpoints: Minimal Residual Disease Eyed As Surrogate
More work needs to be done to validate MRD as predictive of clinical outcomes in hematological malignancies before it can be used as the basis for accelerated approval, FDA and other stakeholders say.
Big Pharma Explores New Frontier Of Lung Cancer Immunotherapy
Lung cancer wasn’t viewed traditionally as a tumor that would respond to immunotherapy. But with checkpoint inhibitor data looking promising, big pharma is diving in and prioritizing the disease, reeled in by the large patient population and high unmet need.
Sponsors’ Use Of Adaptive Designs Appears To Be Growing
A Drug Information Association working group survey found 477 studies between Jan. 1, 2008 and Sept. 1, 2011 utilized some type of adaptive design.