© 2003 by Oxford University Press
© 2003 Oxford University Press
EDITORIAL |
Inflammatory Breast Issue
Affiliation of authors: C. N. Coleman, P. E. Wallner (Radiation Research Program), J. S. Abrams (Cancer Therapy Evaluation Program), Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Correspondence to: C. Norman Coleman, MD, Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bldg. 10, Rm. B3B69, MSC 1002, Bethesda, MD 20892 (e-mail: ccoleman@mail.nih.gov).
| The first 150 words of the full text of this article appear below. |
When we were invited to write an editorial on the emerging use of partial-breast irradiation and accelerated partial-breast irradiation, the following questions arose:
- When should and do new treatment approaches enter routine clinical use?
- When are phase II and pilot data from single institutions ready for general applicability?
- Does the approval of a new device by the U.S. Food and Drug Administration imply it is ready for general clinical applicability?
- How can innovative approaches that require long-term data to judge equivalency be made available in the short and medium term?
- What are the roles of professional societies, research institutions, oversight bodies, and the National Cancer Institute in the introduction of new treatments?
- How might overly cautious interpretation of pilot data inappropriately delay implementation of novel and/or breakthrough treatments?
- How might overly enthusiastic interpretation of pilot data inappropriately promote implementation of novel treatments?
- How does one ensure proper quality assurance as
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