Using Real-world Data to Take Better Baseline Patient Measurements

After recruitment and on-boarding, patients in clinical trials undergo a battery of baseline measurements. However, measurements can vary significantly from moment to moment and “normal” ranges are often wide. Therefore, an approach that uses multiple measurements could help reduce this uncertainty and improve clinical trials.

According to Terry Katz, “But perhaps even more promising is making available the patient’s historical records for the clinician to judge whether the current reading is in line with historical readings. In a clinical trial setting, however, that real-world data (RWD) is typically not available. That could potentially be rectified by gaining approval from the study participant for proactive access to their historical records. Historical values could then be used to project the range for a new value to establish if a baseline is within or outside of historical expectations.”

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(Source: Clinical Leader, March 6^th, 2023)