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Ethics of Using Controls and Placebo in Clinical Trials

HENRY WILDE, M.D.*, CHUMSAK PRUKSAPONG, M.D.***, SURASAK TANEEPANICHSKUL, M.D.** SUKHIT PHAOSAVASDI, M.D.**, YUEN TANNIRANDORN, M.D.**,

Affiliation : * Queen Saovabha Memorial Institute, Thai Red Cross Society, Bangkok 10330. ** Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330. *** Department of Surgery, Police Hospital, Bangkok 10330, Thailand.

Thailand has a solid academic medical community and a good health care infrastructure. This makes it attractive for the pharmaceutical in- dustry to use as a product testing ground. Consi- derable support for medical research has resulted from this and has generally benefited the academic community and industry. However, not all of the projects were well designed or ethica1Cl,2). Fortu- nately, international standards for clinical trials have now been formulated and are known as the "WHO Good Clinical Practices Guidelines" (GCP)(3). These, however, seem to be more concerned with raining in poor study design and lax scientific practices rather than poor ethics. We have had many past examples of studies having been conducted in this country that were of questionable ethics as well as poor design and could never be published in a respected international peer review journal. Such studies often served as a tool to promote the product and had no other merit other than that the local team was later invited to present the data at conferences, usually .held at luxury resorts.

Keywords : Ethics, Placebo


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MEDICAL ASSOCIATION OF THAILAND
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