Clinical trials

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Introduction Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Second is an observational study in which individuals are observed and their outcomes are measured by the investigators. The first clinical trial of a novel therapy was conducted unintentionally by the Renaissance surgeon Ambroise Parè in 1537. He used a concoction of turpentine, rose oil and egg yolk to prevent the infection of battlefield wounds, noting that the new treatment was much more effective than the traditional formula. The first trial using properly randomized treatment and control groups was carried out in 1948 by the Medical Research Council, and involved the use of streptomycin to treat pulmonary tuberculosis. This trial also featured blind assessment (2). In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 Nazi physicians and 3 administrators for their willing participation in carrying out the harmful research on unwilling human subjects. Thus, Nuremberg code was the first international code for the ethics to be followed during human subject research. It was permissible medical experiments implemented in August 1947. The code also provides few directives for clinical trials (3). Syphilis study at Tuskegee in 1974 was the most influential event that led to the HHS Policy for Protecti... ... middle of paper ... ...genome. A brief history of clinical trials. [http://genome.wellcome.ac.uk/doc_wtd020948.html.] Accessed 2011 Apr. 15 3) Protecting Human Research Participants. [http://phrp.nihtraining.com/history/04_history.php.] Accessed 2011 Apr. 15 4) Beauchamp, T. and Childress, J. Principles of Biomedical Ethics. Oxford Press, 6th edition, 2009 5) Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145 6) http://www.bioethics.nih.gov/hsrc 7) Jenkins J., Hubbard S. History of clinical trials. Semin Oncol Nurs. 1991; 7(4): 228-234 8) Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5 9) Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
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