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

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.

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.

Demonstrating NCO utility for biologic vs. small-molecule comparisons validates the approach for an expanding range of comparative effectiveness questions relevant to pharma partners developing biologics.

NCO-based comparability assessment for biologic vs. small-molecule comparative effectiveness in pharma programs, NCO gating framework extension to biologic therapy comparative effectiveness design