Module 2-2A – Choosing Outcomes and Endpoints (16-min video)

• This module explores how to select trial endpoints that reflect real-world priorities, emphasizing that outcomes must matter to patients, providers, and healthcare systems. It explains the difference between “endpoints” and “outcomes,” and guides learners in choosing measures that are both clinically meaningful and feasible to collect using routine care data. 

** The content, slides, and narrator's voice were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **

Outcome measures in the real world (PDF) 

• Pragmatic clinical trials aim to mirror real-world care so their findings can guide everyday treatment choices. Selected outcomes should ideally:

  • Matter to patients, clinicians and policy-makers, 

  • Be easy to capture using routinely collected data, and 

  • Not be a “surrogate” endpoint. 

• Researchers are urged to follow participants over meaningful time-frames for the outcomes to manifest, use objective data to reduce bias in open-label settings, and keep trial procedures from disrupting normal practice. Early discussion with all partners helps ensure outcomes are relevant, feasible and accurately recorded, delivering evidence that can be trusted for everyday clinical decisions.