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Time to tumor growth helps predict survival benefit of Bevacizumab for patients with metastatic colorectal cancer
Date:5/8/2013

the paper, said: "This approach of combining modeling with longitudinal tumor-size data may contribute to improved design and analysis of more informative early-stage clinical studies (Phase Ib, II). It could also enable researchers to select the most promising treatments and reduce the high attrition rate in Phase III oncology studies."

Robert Powell, PharmD, former senior advisor at Roche China, and co-author of the paper, added: "It is important to know whether patients in a new market (e.g., China, India, Brazil) will be similar to patients in the original US or EU New Drug Application (NDA). While pharmaceutical companies usually assume patients from different regions are the same, there is emerging evidence that they might be different with regard to efficacy, safety and dose response. This type of analysis helps better define Chinese colon cancer response relative to Western patients. Roche performed this combined Chinese and US NDA study analysis to learn whether Chinese patients responded similarly to Western patients so they can use this information to plan future trials. Likewise knowing these results will be important to local regulatory agencies such as the China Food and Drug Administration in this case."


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Contact: Lisa Osborne
lisa@ranahealth.com
206-992-5245
Rana Healthcare Solutions LLC
Source:Eurekalert

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