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Guest Editorial

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

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The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.

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Byline
Laura A. Levit, JD
Senior Director, Research Analysis and Publications, Center for Research and Analytics, American Society of Clinical Oncology
Mark J. Ratain, MD
Director, Center for Personalized Therapeutics, Leon O. Jacobson Professor of Medicine, Chief hospital pharmacologist, University of Chicago Medicine
Julie R. Gralow, MD
Chief medical officer, Executive vice president, American Society of Clinical Oncology
Clifford A. Hudis, MD
CEO, American Society of Clinical Oncology, Executive vice chair, Conquer Cancer Foundation; Consultant medical oncologist, Memorial Sloan Kettering Cancer Center
Elizabeth Garrett-Mayer, PhD
Vice president, Center for Research and Analytics, American Society of Clinical Oncology
Table of Contents

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Byline
Laura A. Levit, JD
Senior Director, Research Analysis and Publications, Center for Research and Analytics, American Society of Clinical Oncology
Mark J. Ratain, MD
Director, Center for Personalized Therapeutics, Leon O. Jacobson Professor of Medicine, Chief hospital pharmacologist, University of Chicago Medicine
Julie R. Gralow, MD
Chief medical officer, Executive vice president, American Society of Clinical Oncology
Clifford A. Hudis, MD
CEO, American Society of Clinical Oncology, Executive vice chair, Conquer Cancer Foundation; Consultant medical oncologist, Memorial Sloan Kettering Cancer Center
Elizabeth Garrett-Mayer, PhD
Vice president, Center for Research and Analytics, American Society of Clinical Oncology
Table of Contents

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