What are the Challenges of Flexible Inclusion Criteria?
While flexible criteria have numerous benefits, they also present certain challenges:
Heterogeneity: A more diverse patient population can lead to greater variability in responses, complicating data analysis. Safety Concerns: Including patients with comorbidities or poor performance status may increase the risk of adverse events. Regulatory Hurdles: Approval processes might be more stringent when flexible criteria are used, requiring additional justifications and safeguards.
