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More articles from CCR Perspectives in Regulatory Science and Policy

Advancing Drug Development in Gynecologic Malignancies
Julia A. Beaver, Robert L. Coleman, Rebecca C. Arend, Deborah K. Armstrong, Sanjeeve Bala, Gordon B. Mills, Anil K. Sood, Thomas J. Herzog

Clinical Cancer Research Aug 2019, 25 (16) 4874-4880; DOI: 10.1158/1078-0432.CCR-19-0619
Clinical Development of Novel Drug–Radiotherapy Combinations
Saif S. Ahmad, Marka R. Crittenden, Phuoc T. Tran, Paul G. Kluetz, Gideon M. Blumenthal, Helen Bulbeck, Richard D. Baird, Kaye J. Williams, Tim Illidge, Stephen M. Hahn, Theodore S. Lawrence, Patricia A. Spears, Amanda J. Walker, Ricky A. Sharma

Clinical Cancer Research Mar 2019, 25 (5) 1455-1461; DOI: 10.1158/1078-0432.CCR-18-2466
Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections
Janice Kim, Harpreet Singh, Kassa Ayalew, Kristina Borror, Michelle Campbell, Laura Lee Johnson, Alyson Karesh, Ni A. Khin, Joanne R. Less, Jerry Menikoff, Lori Minasian, Sandra A. Mitchell, Elektra J. Papadopoulos, Richard L. Piekarz, Kevin A. Prohaska, Susan Thompson, Rajeshwari Sridhara, Richard Pazdur, Paul G. Kluetz

Clinical Cancer Research Apr 2018, 24 (8) 1780-1784; DOI: 10.1158/1078-0432.CCR-17-2555
The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications
Kenneth C. Anderson, Daniel Auclair, Gary J. Kelloff, Caroline C. Sigman, Hervé Avet-Loiseau, Ann T. Farrell, Nicole J. Gormley, Shaji K. Kumar, Ola Landgren, Nikhil C. Munshi, Michele Cavo, Faith E. Davies, Alessandra Di Bacco, Jennifer S. Dickey, Steven I. Gutman, Howard R. Higley, Mohamad A. Hussein, J. Milburn Jessup, Ilan R. Kirsch, Richard F. Little, Robert D. Loberg, Jens G. Lohr, Lata Mukundan, James L. Omel, Trevor J. Pugh, Gregory H. Reaman, Michael D. Robbins, A. Kate Sasser, Nancy Valente, Elena Zamagni

Clinical Cancer Research Aug 2017, 23 (15) 3980-3993; DOI: 10.1158/1078-0432.CCR-16-2895
FDA's Approach to Regulating Biosimilars
Steven J. Lemery, M. Stacey Ricci, Patricia Keegan, Amy E. McKee, Richard Pazdur

Clinical Cancer Research Apr 2017, 23 (8) 1882-1885; DOI: 10.1158/1078-0432.CCR-16-1354
An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies
Julia A. Beaver, Abraham Tzou, Gideon M. Blumenthal, Amy E. McKee, Geoffrey Kim, Richard Pazdur, Reena Philip

Clinical Cancer Research Mar 2017, 23 (6) 1368-1372; DOI: 10.1158/1078-0432.CCR-16-1098
Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents
Meredith K. Chuk, Yeruk Mulugeta, Michelle Roth-Cline, Nitin Mehrotra, Gregory H. Reaman

Clinical Cancer Research Jan 2017, 23 (1) 9-12; DOI: 10.1158/1078-0432.CCR-16-1367
Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study
Kun He, Huanyu Chen, Thomas Gwise, Sandra Casak, Steven Lemery, Patricia Keegan, Richard Pazdur, Rajeshwari Sridhara

Clinical Cancer Research Nov 2016, 22 (21) 5167-5170; DOI: 10.1158/1078-0432.CCR-16-1010
The Role of Neoadjuvant Trials in Drug Development for Solid Tumors
Samuel A. Funt, Paul B. Chapman

Clinical Cancer Research May 2016, 22 (10) 2323-2328; DOI: 10.1158/1078-0432.CCR-15-1961
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative
Jonathan P. Jarow, Sandra Casak, Meredith Chuk, Lori A. Ehrlich, Sean Khozin

Clinical Cancer Research May 2016, 22 (9) 2111-2113; DOI: 10.1158/1078-0432.CCR-15-2082

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