Negative Control Outcomes to Assess the Comparability of Biologics versus Small-molecule Therapeutics for Osteoporosis: Considerations for Differential Non-adherence.

Challenge

NCOs had been applied primarily in studies of conventional small-molecule drugs, but whether they could reliably assess the comparability of biologic versus small-molecule treatment groups had not been evaluated in an osteoporosis setting.

Solution

Target RWE researchers applied NCOs to compare biologic versus small-molecule treatment groups in an osteoporosis cohort, demonstrating how NCO balance or imbalance reveals whether standard confounding adjustment has achieved comparable groups.