By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in historical past Affecting the law of scientific examine (pages 1–11):
Chapter 2 the method: constructing New medicinal drugs, Biologics, and units (pages 13–48):
Chapter three sturdy scientific perform and the laws (pages 49–72):
Chapter four proficient Consent and the laws (pages 73–100):
Chapter five Institutional evaluation forums (pages 101–121):
Chapter 6 opposed occasions and Unanticipated difficulties related to dangers to matters or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The critical Investigator, the medical study Coordinator, and the research web site (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 examine Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven research actions (pages 213–244):
Chapter 12 examine Documents/Essential records (pages 245–269):
Chapter thirteen administration of research medicines, Biologics, and units (pages 271–279):
Chapter 14 handling scientific Trial info (pages 281–311):
Chapter 15 worldwide well-being and overseas Trials (pages 313–324):
Read or Download A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition PDF
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Additional info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
Unlike drugs, which are chemically synthesized, biologics are complex mixtures not easily identified or characterized. They include: n Allergenics, such as patch tests used to diagnose causes of dermatitis and extracts used to diagnose and treat hay fever, allergic sinusitis, allergic conjunctivitis, and bee stings n Blood and blood components including red blood cells, platelets, and plasma n Pharmaceutical products made from blood including immunoglobulins and clotting factors n Medical devices and tests used to safeguard blood and blood components n Cellular products, such as human stem cells and pancreatic islet cells n Gene therapies n Human tissues, including skin, tendons, ligaments, and cartilage n Vaccines n Xenotransplantation products that use live animal cells, tissues, or organs to treat human diseases such as liver failure and diabetes, where human materials are not always available12 over-the-counter, before marketing; b) watching for problems, such as unexpected health problems and inadequate supply after drug approval and marketing; c) monitoring drug information for accuracy and truthfulness regarding effectiveness and side effects; and d) protecting drug quality to ensure a safe and effective supply.
The Form FDA 1571 includes the statements “I agree not to begin clinical investigations until 30 days after FDA’s receipt of the IND unless I receive earlier notification by FDA that the studies may begin. I also agree not to begin or continue clinical investigations covered by the IND if those studies are placed on clinical hold. I agree that an Institutional Review Board (IRB) that complies with the requirements set forth in 21 CFR Part 56 will be responsible for initial and continuing review and approval of each of the studies in the proposed clinical investigation.
Liu and Kate Davis © 2010 by Duke Clinical Research Institute. qxd 11/16/09 15:17 Page 14 The process of developing new drugs is expensive and lengthy, requiring an average of ten years or longer to move a product from pre-clinical studies to marketing approval; the costs can range up to a billion dollars. Many experimental compounds never make it out of the laboratory; those that do move out of the laboratory often fail testing in animal models; and still others that reach clinical trials in humans may demonstrate toxicity or a lack of efficacy.
A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition by Margaret B. Liu, Kate Davis(auth.)