The ethics of randomized clinical trials

Am J Med. 1987 Feb;82(2):283-90. doi: 10.1016/0002-9343(87)90069-6.


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.

MeSH terms

  • Clinical Trials as Topic* / methods
  • Clinical Trials as Topic* / supply & distribution
  • Control Groups
  • Disclosure
  • Double-Blind Method
  • Ethics, Medical*
  • Humans
  • Informed Consent
  • Patient Selection
  • Placebos
  • Random Allocation
  • Research Design
  • Research Subjects
  • Risk Assessment
  • Therapeutic Human Experimentation*


  • Placebos