TY - JOUR
T1 - What can be done to improve research biopsy quality in oncology clinical trials?
AU - Ferry-Galow, Katherine V.
AU - Datta, Vivekananda
AU - Makhlouf, Hala R.
AU - Wright, John
AU - Wood, Bradford J.
AU - Levy, Elliot
AU - Pisano, Etta D.
AU - Tam, Alda L.
AU - Lee, Susanna I.
AU - Mahmood, Umar
AU - Rubinstein, Lawrence V.
AU - Doroshow, James H.
AU - Chen, Alice P.
N1 - Publisher Copyright:
Copyright © 2019 American Society of Clinical Oncology. All rights reserved.
PY - 2018/2
Y1 - 2018/2
N2 - Purpose Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient’s contribution to and potential benefit from a clinical trial. Methods To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices. Results Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality. Conclusion Implementing these recommendations at the National Cancer Institute’s Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.
AB - Purpose Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient’s contribution to and potential benefit from a clinical trial. Methods To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices. Results Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality. Conclusion Implementing these recommendations at the National Cancer Institute’s Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.
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U2 - 10.1200/JOP.18.00092
DO - 10.1200/JOP.18.00092
M3 - Article
C2 - 30285529
AN - SCOPUS:85069932945
SN - 1554-7477
VL - 14
SP - e722-e728
JO - Journal of oncology practice
JF - Journal of oncology practice
IS - 11
ER -