Ethics and clinical trials

The current reference guideline about ethics in clinical trials is the Decl aration of Helsinki of human rights in medical research. Three major princi ples are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participat e in studies. The investigator is responsible for obtaining a free and well -informed consent from patients before their inclusion in a study. Where: p ossible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versu s a reference treatment can lead to an erroneous conclusion of absence of d ifference. Moreover, good results or improvement are obtained in at least 3 0% of cases with placebo, whatever the disease. The use of placebo is uneth ical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, i n some severe diseases even when an active reference treatment is available , and in all moderate and functional diseases. In order to detect flawed st udies, most journals now ask for any manuscript submitted and reporting res ults of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doc tor to decide whether or not a protocol is ethical, to participate or not a nd to include patients or not.