Abstract

Hilden and Gammelgaard's (H&G) comments on the evaluation and application of statistical trials and on informed consent lead to the same conclusion that there are special circumstances when clinical trials are performed in emergency situations.

The decision to comment on the work that H&G responded to was motivated by the wish to manifest the need to reach a consensus on modifying the conditions in which clinical trials should be performed in special circumstances.

One unquestionable fact must first be addressed: clinical trials are necessary for acquiring new knowledge and consequent improvements in health care services. At the same time, patient participation should be encouraged under conditions that respect patients' decision making capability.

Are these conditions being met at present? An answer to this is given below.