Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: A narrative review

Negative control outcome studies are increasingly used to evaluate unmeasured confounding in comparative effectiveness research, but practical guidance on how to select, implement, and interpret NCOs in real-world pharmacoepidemiologic settings was lacking.

Target RWE researchers co-authored a narrative review in Pharmacoepidemiology & Drug Safety synthesizing pragmatic considerations for NCO study design, including domain-based confounding identification, NCO selection criteria, and interpretation frameworks for non-null findings.

Providing an accessible, practice-oriented guide to NCO studies accelerates their adoption as a standard validity check in Target RWE's comparative effectiveness portfolio, strengthening study credibility for pharma partners and regulatory reviewers.

NCO study design guidance for comparative effectiveness validity in pharma partnerships, Practical framework for identifying and interpreting negative control outcomes in real-world data