Evidence gaps take many forms. A patient group that was excluded from the pivotal trials. A comparison with a competitor that has never been made head to head. Long-term outcomes that a two-year study cannot show. An endpoint payers care about that the trials did not measure. Uncertainty about how a treatment performs in everyday practice rather than in a trial.
Medical Affairs teams find evidence gaps in several ways: by analyzing the published literature, by listening to the questions experts raise in scientific exchange, by tracking the topics that come up repeatedly in medical information inquiries, and by reading the feedback from health technology assessment bodies and payers.
Once identified, gaps are prioritized by how much they matter and how feasible it is to close them, and they shape the evidence generation plan. That plan might include new clinical trials, investigator-initiated studies, analyses of existing data, or real-world evidence studies.
A gap that is well documented is also useful for communication. Being able to say clearly what is not yet known is part of a credible scientific position.