Principles and Practice of Clinical Research, Third Edition

Principles and Practice of Clinical Research, Third Edition

Language: English

Pages: 796

ISBN: 0123821673

Format: PDF / Kindle (mobi) / ePub

The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

  • Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research
  • Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research
  • Delves into data management and addresses how to collect data and use it for discovery
  • Contains valuable, up-to-date information on how to obtain funding from the federal government

















minimal risk to children is acceptable, research with more than minimal risk must either be counterbalanced by a prospect of direct therapeutic benefit for the children in the study, or by the importance of the question in children with the disorder 3/21/2007 3:47:28 PM 20 Principles and Practice of Clinical Research under study, or be approved by a special panel convened by the U.S. Secretary of DHHS.22 Permission for the research participation of children is sought from their parents or

Emanuel EJ. Cost savings at the end of life: What do the data show? JAMA 1996;275:1907–1914. 51. Brooks CH, Smyth-Staruch K. Hospice home care cost savings to third party insurers. Med Care 1984;22:691–703. 52. Spector WD, Mor V. Utilization and charges for terminal cancer patients in Rhode Island. Inquiry 1984;21:328–337. 53. Mor V, Kidder D. Cost savings in hospice: Final results of the National Hospice Study. Health Serv Res 1985;20:407–422. 54. Kane RL, Bernstein L, Wales J, Leibowitz A,

and other clinical or research alternatives.26 Attention has been given to additional protections for research involving people with mental disorders27 and research conducted in emergency circumstances.28 Subject Privacy and Confidentiality Are Maximized (Table 5-1, #7) Confidentiality refers to the management of information that an individual has disclosed in a relationship of trust; an expectation is that it will not be divulged to others in ways that are inconsistent with the understanding of

to answer the questions posed. If participant accrual or adherence to the intervention regimen is poor, the study’s power may be inadequate, and study continuation may not be scientifically or ethically appropriate. The latter type of report would consist of primary outcome variables, adverse events, other outcome measures such as laboratory tests, and interim variables that assess if the intervention is having the postulated physiologic or biochemical effects. The frequency of data reports

hepatitis B. Gastroenterology 1988;95:1318–1325. 17. Perillo RP, et al. A randomized, controlled trial of interferon-a2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. N Engl J Med 1990;323:295–301. 3/21/2007 3:51:47 PM 94 Principles and Practice of Clinical Research 18. Paar DP, et al. The effect of FIAU on chronic hepatitis B virus (HBV) infection in HTV-infected subjects (ACTG 122b). In Program and Abstracts of the 32nd Interscience Conference on

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