Experience has indicated, however, that if that patient is accepted, another physician will request that a patient be accepted although therapy begins 35 days after operation, because there is no proof that 3 more days will matter. Before long, there seems to be no rational reason for imposing a time restriction. Yet there is likely to be a time beyond which delay would be unacceptable. Modulation of restrictions may be justified, but any changes must be decided upon before the onset of a trial and then rigidly adhered to once the study has begun. Less rigid rules are to be encouraged as long as there is no reason to believe that doing so will interfere with obtaining firm answers to the biologic and clinical questions under investigation.
Clinical trials supply information about the value of therapies before their widespread use.
It is impossible to estimate the number of patients who might have been spared treatment by therapies of dubious repute had the value of those therapies been assessed by proper clinical trials before being replaced by treatments of equally questionable worth. This approach presents no problem when the treatment in the control arm is used, since that most often represents standard therapy. It must be emphasized, however, that the implementation of a trial to evaluate the worth of a therapeutic agent does not provide physicians with an imprimatur to administer, outside of a trial, the therapy being tested in the trial. That action is improper. Clinical trials are conducted to ensure that a group of patients who receive a particular therapy is as comparable as possible to a control group that does not receive it.