The dilemma of clinical research. Historical and philosophical considerations of physicians' ambitions and patients' fear.
2004
undreds of years ago, the tradition of experimenting on individual patients was carried out sporadically. There was very little distinction between experimentation and therapy as most therapies were experimental. Systematic evidence of the effectiveness of various treatment interventions was lacking. Experimental therapies were then tried to benefit ailing patients. Unfortunately at times such therapies led to worsening medical status. Most researchers were medical practitioners, who were motivated and trusted to do what they thought best for the patients. Fraud and abuse were minimized through peer censorship rather than reviewership. There was no specific code of ethics, laws, or regulations governing the conduct of scientific research. Early in the 19th century after the development of Penicillin by Alexander Fleming and other antibiotics, drugs were required to prove evidence of safety by law before being marketed. This stipulation has given immense attention to scientific research particularly from regulating bodies and pharmaceutical industry and also led to distinguishing the clinical practitioner from the clinical researcher. Generally, clinical practice refers to activities and interventions that are designed solely to enhance the well being of an individual patient and have a reasonable expectation of success. However, the goal of the research is to develop a general knowledge to better understand health and improve health care with similar disorders or risk profiles as well as for future patients and the society. 1 Therefore, clinical practice consists of activity to diagnose, prevent, treat or care for an illness or condition in a particular individual in order to benefit that individual whereas, clinical research is designed to answer a question and generate knowledge useful to others. Hence, it is paramount to distinguish between conducting biomedical and behavioral research on one hand and the practice of medicine on the other for several reasons. These relate to ethical, professional, financial and other issues that can generate potential conflicts of interest when physicians conduct research involving people, and particularly their own patients. Clinical
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