An observational study, also referred to as a non-interventional study (NIS), is a study design in which patients are observed in their natural treatment routine without active intervention in the therapy. The medicinal product is prescribed in accordance with its marketing authorisation and routine medical practice; no protocol-driven diagnostic measures take place beyond standard care.
Such studies are of inestimable value for generating Real-World Evidence (RWE). While classic RCTs assess efficacy under ideal conditions, observational studies show effectiveness and safety in a heterogeneous patient population in everyday practice. They are frequently used for long-term safety surveillance (PASS) or to investigate real-world care patterns.
For CROs, conducting such studies requires specific expertise in data modelling and in handling Real-World Data (RWD). Because control over the data is less strict than in interventional trials, statistical methods such as propensity score matching must be applied to minimise confounding factors. NIS are an essential component of a medicinal product’s lifecycle management.
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