Trial Evidence & Real-World Evidence
Randomised trials and studies of real-world data answer different questions and can complement each other. This page lists frameworks, methods and research on real-world evidence, and resources for judging how far trial results apply to patients in Saudi Arabia. Saudi population figures for such comparisons are in the national health facts on the Overview page.
Regulatory & Health Technology Assessment Frameworks
| Resource | What it offers | Access |
|---|---|---|
| Framework on the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to Support Effectiveness and Safety for Marketing Authorization of Medicinal Products — Saudi Food and Drug Authority | Saudi expectations for real-world data quality, study designs and use of real-world evidence | Named document; on the authority's website |
| Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products — US Food and Drug Administration | FDA guidance on real-world evidence in drug decisions | Free |
| Real-world evidence — European Medicines Agency | EMA's reflection paper, data quality framework and guidance on registries | Free |
| ICH E6(R3) Annex 2 — International Council for Harmonisation | Good clinical practice for trials with decentralised or pragmatic elements, or that use real-world data | Free |
| Real-world data and real-world evidence in regulatory decision making — Council for International Organizations of Medical Sciences (CIOMS) | An international consensus report on concepts, data quality and regulatory use | Free |
Methods & Protocols
| Resource | What it offers | Access |
|---|---|---|
| Causal Inference: What If — free online textbook | Causal inference, confounding and target trial emulation, with code and data | Free |
| HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force — Pharmacoepidemiology and Drug Safety, 2022 | HARPER, a shared protocol template for real-world evidence studies | Free |
| Guide on Methodological Standards in Pharmacoepidemiology — European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) | Methods for study design, bias, target trial emulation and protocols | Free |
| Catalogues of real-world data sources and studies — Heads of Medicines Agencies and European Medicines Agency | Searchable European real-world data sources and registered studies, with protocols | Free |
| Real-World Evidence Registry — ISPOR and partners | Registration of real-world evidence study protocols before the study starts | Free, registration |
| The Book of OHDSI — OHDSI | The OMOP common data model, vocabularies and analytics | Free |
| OMOP Common Data Model — OHDSI | The specification for standardising health data for multi-site studies | Free |
Comparing Real-World Evidence With Trial Results
| Resource | What it offers | Access |
|---|---|---|
| Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses — JAMA, 2023 | Compares results of database studies designed to emulate published trials with the trials' own results | Free |
Applying Trial Results To Patients In Saudi Arabia
| Resource | What it offers | Access |
|---|---|---|
| Completing 'Summary of findings' tables and grading the certainty of the evidence — Cochrane Handbook | Judging indirectness when a trial's population differs from the population of interest | Free |
| Drug Trials Snapshots — US Food and Drug Administration | Demographics and countries of participants in the main trials behind new US drug approvals | Free |
| Clinical trials guidance documents — US Food and Drug Administration | FDA trial guidance, including guidance on enhancing the diversity of trial populations | Free |
| Table of Pharmacogenomic Biomarkers in Drug Labeling — US Food and Drug Administration | Drugs whose US labels contain pharmacogenomic information | Free |
Where Trials Were Run
| Resource | What it offers | Access |
|---|---|---|
| ClinicalTrials.gov — US National Library of Medicine | Registered trials worldwide, with sites, eligibility criteria and posted results | Free |
| International Clinical Trials Registry Platform — World Health Organization | A single search across WHO primary trial registries | Free |
| Clinical Trials Information System public portal — European Medicines Agency | Trials in the European Union and European Economic Area | Free |
| Saudi Clinical Trials Registry (SCTR) — Saudi Food and Drug Authority | The national registry for clinical trials in Saudi Arabia; see Research In Saudi Arabia | Named only |
Research On Saudi Arabia & The Region
| Resource | What it offers | Access |
|---|---|---|
| Navigating barriers to real-world evidence utilization for drug regulatory affairs and market access in Saudi Arabia — Frontiers in Pharmacology, 2025 | Stakeholders' views on barriers to generating and using real-world evidence | Free |