Academic Cancer Center Phase I Program Development

Author:

Frankel Arthur E.1,Flaherty Keith T.2,Weiner George J.3,Chen Robert4,Azad Nilofer S.5,Pishvaian Michael J.6,Thompson John A.7,Taylor Matthew H.8,Mahadevan Daruka9,Lockhart A. Craig10,Vaishampayan Ulka N.11,Berlin Jordan D.12,Smith David C.13,Sarantopoulos John14,Riese Matthew15,Saleh Mansoor N.16,Ahn Chul1,Frenkel Eugene P.1

Affiliation:

1. University of Texas Southwestern Medical Center, Dallas, Texas, USA

2. Harvard Medical School, Boston, Massachusetts, USA

3. Holden Comprehensive Cancer Center at the University of Iowa, Iowa City, Iowa, USA

4. City of Hope Comprehensive Cancer Center, Duarte, California, USA

5. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA

6. Georgetown University Medical Center, Lombardi Cancer Center, Washington, DC, USA

7. Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, Washington, USA

8. Oregon Health and Science University, Portland, Oregon, USA

9. University of Arizona Cancer Center, Tucson, Arizona, USA

10. Alvin J. Siteman Cancer Center at the Washington University School of Medicine, St. Louis, Missouri, USA

11. Karmanos Cancer Institute at Wayne State University, Detroit, Michigan, USA

12. Vanderbilt University Medical Center, Nashville, Tennessee, USA

13. University of Michigan, Ann Arbor, Michigan, USA

14. Institute for Drug Development at the Cancer Therapy and Research Center of the University of Texas Health Science Center, San Antonio, Texas, USA

15. Medical College of Wisconsin, Milwaukee, Wisconsin, USA

16. Comprehensive Cancer Center at the University of Alabama, Birmingham, Alabama, USA

Abstract

Abstract Multiple factors critical to the effectiveness of academic phase I cancer programs were assessed among 16 academic centers in the U.S. Successful cancer centers were defined as having broad phase I and I/II clinical trial portfolios, multiple investigator-initiated studies, and correlative science. The most significant elements were institutional philanthropic support, experienced clinical research managers, robust institutional basic research, institutional administrative efforts to reduce bureaucratic regulatory delays, phase I navigators to inform patients and physicians of new studies, and a large cancer center patient base. New programs may benefit from a separate stand-alone operation, but mature phase I programs work well when many of the activities are transferred to disease-oriented teams. The metrics may be useful as a rubric for new and established academic phase I programs.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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