TY - JOUR PY - 1987// TI - The ethics of randomized clinical trials JO - American journal of medicine A1 - Rosner, F. SP - 283 EP - 290 VL - 82 IS - 2 N2 - Randomized clinical trials pose a number of fundamental ethical problems to which morally sensitive investigators must give careful consideration. The randomized double-blind clinical trial is ethically justified and the preferred method of demonstrating therapeutic effectiveness and safety. Alternate methods such as crossover and self-controlled designs, the use of historical controls, observational methods, and practitioner's clinical trials also exist and have their place in certain circumstances. The use of randomized double-blind clinical trials must assure adequate explanation of the research plan to the patient, the documentation of informed consent, adequate consideration of safety, and an acceptably low risk/benefit ratio.

Language: en

LA - en SN - 0002-9343 UR - http://dx.doi.org/ ID - ref1 ER -