ABSTRACT
For traditional clinical trials, the inclusion and exclusion criteria for the intended patient population include clinical endpoints and clinical-pathological signs or symptoms. However, despite the efforts to reduce the heterogeneity of patients, substantial variation exists in the responses to the new treatment even for the patients meeting the same inclusion and exclusion criteria. Because these endpoints and clinical signs or symptoms are not well correlated with the clinical benefits of the treatments in the patient population defined by clinical-based inclusion and exclusion criteria, the current paradigm for the development of a drug or a treatment uses a shot-gun approach that may not be beneficial for most patients. One of the reasons is that the potentially important genetic or genomic variability of the trial participants is not utilized by the traditional inclusion/exclusion criteria.
