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- James C Yao, Funda Meric-Bernstam, J Jack Lee, and S Gail Eckhardt.
- Department of Gastrointestinal Medical Oncology, Investigational Cancer Therapeutics, and Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. jyao@mdanderson.org
- Clin Cancer Res. 2013 Aug 15; 19 (16): 4305-8.
AbstractRecent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments available sooner through the use of smaller studies using intermediate endpoints. Here, we consider the inherent limitations of smaller studies and discuss the strategies for hastening oncology drug development while maintaining high-efficacy standards.©2013 AACR.
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