By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in background Affecting the law of scientific learn (pages 1–11):
Chapter 2 the method: constructing New medications, Biologics, and units (pages 13–48):
Chapter three reliable medical perform and the laws (pages 49–72):
Chapter four expert Consent and the rules (pages 73–100):
Chapter five Institutional assessment forums (pages 101–121):
Chapter 6 adversarial occasions and Unanticipated difficulties regarding hazards to topics or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The central Investigator, the scientific examine Coordinator, and the learn web site (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 learn Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven learn actions (pages 213–244):
Chapter 12 learn Documents/Essential files (pages 245–269):
Chapter thirteen administration of analysis medicines, Biologics, and units (pages 271–279):
Chapter 14 coping with scientific Trial info (pages 281–311):
Chapter 15 worldwide future health 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 resources for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
N A protocol for each planned study. n Names of investigators, facilities, and Institutional Review Boards (IRBs) (or completed Forms FDA 1572) where studies will be conducted. n Chemistry, manufacturing, and control data. n A summary of previous human experience with the test product, including information acquired if the product was investigated or marketed in another country, or if used in combination with other products previously investigated or marketed. 23(a)(1–11). 16 11/16/09 15:17 Page 17 Once the FDA receives an IND application, the FDA has 30 days to review the application before the sponsor can begin clinical testing.
Bendamustine was approved for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL). According to the National Cancer Institute, an estimated 30,000 people in the United States are expected to be diagnosed annually with indolent NHL, a serious and slow-growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. 15 Early or Expanded Access to Unapproved Drugs and Biologics In some situations, drugs or biologics that have not been approved for marketing may be used outside of a clinical trial to save a patient’s life or to relieve suffering from a disease with no alternative treatment.
In such cases, a treatment IND may be issued for the purpose of expanding access to promising new drugs for desperately ill patients who are 24 11/16/09 15:17 Page 25 not participating in the clinical trials. 18 The requirements to issue a treatment IND are: 1) the drug is intended to treat a serious or immediately life-threatening disease; 2) there is no satisfactory alternative treatment; 3) the drug is under investigation or trials have been completed; and 4) the sponsor is actively pursuing market approval.