Real-World Data & RWE

RWD, RWE, registries, claims data, and their use in safety evaluation (EMA RWE guidance, FDA 2026).

21 terms

Data relating to patient health and/or delivery of care routinely collected from sources such as electronic health records, claims, registries, or wearables (FDA RWE Framework).

Real-World Evidence(RWE)

Clinical evidence about use and benefits/risks of a medicine derived from analysis of RWD (FDA). Used to support regulatory decisions including post-market safety.

RWD in Signal Evaluation

Use of real-world data (e.g., claims, EHR, registries) to evaluate or validate safety signals, estimate rates, or assess confounders.

Fitness for Use RWD

Assessment of whether a given RWD source is adequate for the intended PV or safety question (completeness, accuracy, relevance, timeliness).

Loading…

Real-World Data & RWE

RWD, RWE, registries, claims data, and their use in safety evaluation (EMA RWE guidance, FDA 2026).

21 terms

Real-World Data(RWD)

Data relating to patient health and/or delivery of care routinely collected from sources such as electronic health records, claims, registries, or wearables (FDA RWE Framework).

Real-World Evidence(RWE)

Clinical evidence about use and benefits/risks of a medicine derived from analysis of RWD (FDA). Used to support regulatory decisions including post-market safety.

RWD in Signal Evaluation

Use of real-world data (e.g., claims, EHR, registries) to evaluate or validate safety signals, estimate rates, or assess confounders.

Fitness for Use RWD

Assessment of whether a given RWD source is adequate for the intended PV or safety question (completeness, accuracy, relevance, timeliness).

Pregnancy Registry

Prospective, organized collection of data on pregnancy outcomes following exposure to a drug; used for risk characterization and RMP (GVP Module V, XVI).

Pregnancy Follow-Up

Systematic follow-up of reported pregnancies in which the suspect drug was used, to collect outcome data (live birth, miscarriage, congenital anomaly, etc.).

Claims Database Study

Analysis of healthcare claims data (e.g., insurance) to assess drug use, outcomes, and safety in real-world populations.

Post-Authorization Safety Study(PASS)

Study carried out after approval to collect safety (or efficacy) data; may be imposed by authority or voluntary.

Post-Authorization Efficacy Study(PAES)

Study to assess efficacy in real-world use when condition of approval; distinct from PASS but may include safety.

Pregnancy Category

Classification of drug use in pregnancy (e.g., FDA categories, SmPC). Relevant for pregnancy reporting and PPP.

RWD Protocol

Predefined protocol for RWD study (objectives, data source, analysis plan) to ensure scientific rigor.

Electronic Health Record(EHR)

Digital record of patient health information; source of RWD for safety studies.

Confounding RWD

Bias in RWD where another factor is associated with both exposure and outcome; must be addressed in analysis.

Sentinel Initiative

FDA's national system for monitoring medical product safety using electronic health data.

EU PAS Register

EU register of post-authorization studies (PASS, PAES); transparency and protocol registration.

Pharmacoepidemiology

Study of drug use and effects in populations; methods used in signal evaluation and RWE.

Case-Control Study

Study comparing cases (with outcome) to controls (without) for exposure; used in signal evaluation.

Cohort Study

Study following exposed (and sometimes unexposed) cohort for outcomes.

Observational Study

Non-interventional study (e.g., cohort, case-control) using RWD; protocol and ethics required.

Channeling

Bias where drug is prescribed to different patient types; confounds RWD analyses.

Patient Registry

Registry of patients on a drug or with a condition; used for safety and effectiveness.