Successful clinical trials need good patient stratification
Clinical trials fail for several reasons, with efficacy and safety being commonly cited reasons. But another issue may be due to a lack of proper patient stratification. In addition to obvious parameters, patients may need to be stratified in a manner that reflects the pathogenic diversity seen within a disease or by their response to a candidate drug. The reliance on humanized transgenic animal models, coupled with a lack of proper patient stratification, is likely working to reduce the success of clinical trials.