Response Assessment in Clinical Trials: Implications for Sarcoma Clinical Trial Design

Response assessment and design of clinical trials require careful consideration of many factors, especially as validated response criteria can ultimately lead to the approval of an anticancer agent. Current anatomic imaging criteria are difficult to apply for evaluation of certain types of tumors, i...

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Bibliographic Details
Published in:The oncologist (Dayton, Ohio) Ohio), 2008-01, Vol.13 (S2), p.14-18
Main Author: Jaffe, C. Carl
Format: Article
Language:English
Subjects:
Antineoplastic Agents - therapeutic use
Clinical trial design
Clinical Trials as Topic
Contrast Media
Diagnostic Imaging
Disease Progression
Humans
Imaging response
RECIST
Research Design
Response assessment
Sarcoma - diagnosis
Sarcoma - drug therapy
Treatment Outcome
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Summary:Response assessment and design of clinical trials require careful consideration of many factors, especially as validated response criteria can ultimately lead to the approval of an anticancer agent. Current anatomic imaging criteria are difficult to apply for evaluation of certain types of tumors, including soft tissue sarcomas. The emergence of new molecular imaging techniques, such as 64‐slice computed tomography scanners and dynamic contrast magnetic resonance imaging, provide complementary information to conventional anatomical imaging. Currently the U.S. National Cancer Institute and the U.S. Food and Drug Administration are aiming to revise existing response criteria based on the development of volumetric anatomic imaging for oncology. Reviewing existing and new approaches in the design of clinical trials will help to optimize the clinical development and evaluation of new therapies for sarcomas.
ISSN:1083-7159
1549-490X
DOI:10.1634/theoncologist.13-S2-14