Topic > Clinical Trials - 652

IntroductionClinical trials are biomedical or health-related research studies conducted on humans that follow a predefined protocol. Research is an activity designed to test a hypothesis that helps conclude and develop knowledge. It is a protocol that provides objectives and procedures to achieve these objectives (1). There are two types of clinical trials. One is interventional studies in which research subjects are assigned by the researcher to a treatment or other intervention and their outcomes are measured. The second is an observational study in which individuals are observed and their outcomes measured by researchers. The first clinical trial of a new therapy was unintentionally conducted by Renaissance surgeon Ambroise Parè in 1537. He used a mixture of turpentine, rose oil and egg yolk to prevent infection of battlefield wounds, pointing out that the new treatment was very more effective than the traditional formula. The first study using adequately randomized treatment and control groups was conducted in 1948 by the Medical Research Council and involved the use of streptomycin to treat pulmonary tuberculosis. This process also involved blind evaluation (2). In December 1946, the Nuremberg War Crimes Tribunal indicted 20 Nazi doctors and 3 administrators for their willing participation in carrying out harmful research on non-consenting human subjects. Therefore, the Nuremberg Code was the first international code for ethics to be followed during research involving human subjects. Medical experiments carried out in August 1947 were permitted. The code also provides little direction for clinical trials (3). The Tuskegee syphilis study in 1974 was the most influential event leading to HHS policy to protect… half of the document… genome. A brief history of clinical trials. [http://genome.wellcome.ac.uk/doc_wtd020948.html.] Accessed April 2011, 153) Protection of participants in human research. [http://phrp.nihtraining.com/history/04_history.php.] Accessed April 2011 154) Beauchamp, T. and Childress, J. Principles of Biomedical Ethics. Oxford Press, 6th edition, 20095) Freedman B. Equipoise and the ethics of clinical research. N English J Med. 1987; 317(3): 141-1456) http://www.bioethics.nih.gov/hsrc7) Jenkins J., Hubbard S. History of clinical trials. Semin Oncol Nurs. 1991; 7(4): 228-2348) Paul J., Seib R., Prescott T. Internet and clinical trials: context, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e59) 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