Clinical trials in developing countries - ethical considerations.

When designing clinical trial or considering decision to take part in particular clinical trial as investigators, even before submission to responsible Central Ethic Committee, we always make certain private assessment about ethical justification of this clinical trial. When making assessment if any clinical trial is ethically justifiable, there should make no difference in which country this clinical trial will be executed. Physicians coming from developing countries must ensure that patient population of developing countries is not misused in any ethically questionable clinical trial. There must be careful assessment of clinical protocols by various independent local advisory committees (e.g. hospital review boards, hospital drug committees, hospital administration and whatever is applicable) to exclude the possibility that only one person or one group of people has concentrated power to make decisions for entire country. Many times physicians/clinical researchers from developing countries are faced with the criticisms that they are not of the same quality as physicians from developed countries and that they can be easily bribed by sponsors, which are based on the prejudice that any clinical trial can be executed in developing countries, no matter of quality or risks for patients. Physicians coming from developing countries must ensure that patient population of developing countries is not misused in any ethically questionable clinical trial.