Learning Objectives After completing this course, the reader will be able to: Describe the importance of the informed consent process in clinical trials. Discuss the implications of the randomized phase III trial of maintenance paclitaxel chemotherapy in advanced ovarian cancer. Explain the responsibilities of clinical investigators and clinicians to inform their patients of new results that may affect their willingness to participate in clinical trials. Access and take the CME test online and receive one hour of AMA PRA category 1 credit at CME.TheOncologist.com The principle of respect for patient autonomy and the importance of informed consent are well established in the conduct of clinical research. However, in actual clinical practice, how one applies this concept is not always clear. The provocative results of a randomized trial examining “consolidation/maintenance” therapy in women with advanced ovarian cancer who achieved a clinically defined complete response to primary chemotherapy have raised difficult issues for clinicians and clinical investigators regarding their obligations to provide patients with information that may interfere with the conduct of ongoing or future research studies.
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Maurie Markman (2004) studied this question.
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