Grant Williams: Selected publications on cancer drug development and regulation
1. Williams G, Keegan P, Ogden P, Pazdur R, Temple R, McClellan M. FDA’s role in the development and approval of drugs, biologics, and devices for cancer. Chapter in: DeVita and Hellman, eds., CANCER: Principles and Practice of Oncology,7th edition. Lippincott Williams & Wilkins, 2005. (Co-author of 8th edition, 2007)
2. Williams G, Pazdur R. Regulatory Considerations in Clinical Trials of Novel Anticancer Drugs. Chapter in: Adjei and Buolamwini, eds., Novel Anticancer Agents: Strategies for Discovery and Clinical testing. Elsevier, Inc. 2006, 263-283.
3. Williams G. Endpoints for cancer drug approval. ASCO Educational Book, 2005.
4. Williams G. Editorial: Cancer drug development: for populations or for individuals? J Clin Oncol 2004;22 3441-3442.
5. Williams G, Pazdur R, Temple R. Assessing tumor-related signs and symptoms to support cancer drug approval. J Biopharm Stat. 2004 Feb;14(1):5-21.
6. Johnson J, Williams G, Pazdur R. End points and the United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1404-1411, 2003.
7. Chiao J, Williams G, Griebel D. A perspective on assessing tumor-related symptoms and health-related quality of life (HRQL) in cancer clinical trials. Book chapter in: Teicher and Andrews, eds., Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials and Approval. Humana Press, 2004.
8. Dagher R, Johnson, J, Williams G, Keegan P, Pazdur R. Accelerated Approval of Oncology Products: A Decade of Experience JNCI, Vol. 96, No. 20, October 20, 2004.
9. Williams G, Tun H, Pazdur R, and Chi G. Operational bias in assessing time to progression Time to Progression, Proceedings of ASCO, 2002. 21: Abstract #975.
10. Williams G, Cortazar P, Pazdur R. Developing drugs to decrease the toxicity of chemotherapy. J Clin Oncol. 2001 Jul 15;19(14):3439-41.
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