Maurie Markman, MD
In recent years there has been much discussion about the serious limitations of the conduct and interpretation of randomized trials examining the utility of antineoplastic drug therapy. Concerns include the intentional or unintentional exclusion of elderly patient populations and individuals with common and clinically relevant comorbidities (eg, current or past history of cardiac illness). Although the desire is to create the most homogeneous study population possible in order to isolate the clinical utility of an investigative strategy, the unfortunate end result is often that a very large percentage of real-world patients with cancer is excluded, casting doubt upon the overall relevance of the trial outcome.
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