Excerpt from National Cancer Institute Annual Report, Vol. 2: October 1, 1989, Through September 30, 1990
The Investigational Drug Branch (108) is responsible for sponsoring trials of new investigational drugs and of evaluating them for efficacy and toxicity. It does this by: I) Coordinating and monitoring the trials of new agents developed by the oct; 2) Planning with members of the Clinical Investigations Branch (see below overall strategies for new agent studies in specific tumor types; 3) Regulating the distribution of investigational new drugs for which oct is the sponsor; 4) Maintain close contact and ongoing dialogue with the pharmaceutical industry in an attempt to ensure that new agent development proceeds in a coordinated way.
The Clinical Investigations Branch (cib) is responsible for development and implementation of disease-oriented treatment strategies across the spectrum of human malignancies. In doing so, it provides management and oversight of the clinical cooperative group program. It manages the oncology portfolios of R01 and P01 grants.
The Regulatory Affairs Branch (rab) monitors the conduct of clinical trials performed in the nci-supported clinical trials network. It also assures that clinical investigators using experimental agents are in compliance with federal regulations regarding the use of such agents. At the start of the clinical testing of each investigational agent, rab obtains Investigational New Drug (nda) exemption authorization from the Food and Drug Administration (fda) and maintains close communication with fda in all matters relating to experimental drug studies.
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Paperback. Zustand: New. Print on Demand. This book presents a comprehensive analysis of the Cancer Therapy Evaluation Program (CTEP), a vital component of the National Cancer Institute (NCI). The CTEP plays a crucial role in coordinating and monitoring clinical trials for cancer treatments, ensuring the safety and effectiveness of new therapies. The author provides a detailed account of the CTEP's history, structure, and functions, highlighting its impact on cancer research and patient care. Through the examination of various case studies, the book demonstrates the CTEP's rigorous approach to clinical trial design, data analysis, and regulatory oversight. The author also explores the challenges faced by the CTEP, including the need for efficient trial designs, effective communication with the medical community, and maintaining a balance between scientific rigor and patient safety. This book serves as a valuable resource for researchers, clinicians, and policymakers involved in cancer treatment development, offering insights into the complexities and importance of clinical trial evaluation in advancing the fight against cancer. This book is a reproduction of an important historical work, digitally reconstructed using state-of-the-art technology to preserve the original format. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in the book. print-on-demand item. Bestandsnummer des Verkäufers 9780243586332_0
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