What do we miss with the traditional efficacy/safety evaluation?

The traditional efficacy/safety evaluation has mainly been based on objective clinical features, findings and tests. Subjective symptoms have often been taken into account and much efforts have been put into the methods of their measurement. The emotional, social and functional consequences of disease, however, seldom have received much attention. Little attention has also been paid to patients expectation and the true causes of why the patient has sought medical help. Important aspects of disease and consequences of intervention are therefore often missed when adhering only to the traditional methods of evaluation.