Real-World Evidence Conference

Cohort blindness is the gap between the patient population a protocol describes and the one structured data can actually see: eligibility criteria written against clinical reality, then tested against coded fields that never captured it. The cost is measurable. Seventy-six percent of clinical trial protocols now require an amendment, most often to eligibility criteria, at $141K to $535K and an average of 260 days each (Tufts CSDD), and most of these trace back to cohort assumptions that could not be validated before protocol lock. Dr. Or Shaked will show how cohort blindness arises from coding practice, missingness, and data model constraints, why it stays invisible until enrollment fails, and what changes when eligibility logic can be tested, kept visible, and recalculated before lock. Attendees will leave with a framework for diagnosing cohort blindness in their own studies and criteria for judging whether an AI approach is methodologically aware or simply fast.