In clinical research, “fit-for-purpose” refers to a tool, method, dataset, or process that is appropriate and validated for its intended use, even if it does not meet the highest possible standard across all use cases.

Regulators, such as the FDA and EMA, often use this term when evaluating biomarkers, endpoints, or data sources that may not be fully validated for every setting, but are sufficient and reliable for a specific decision-making context within a given trial.