Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps?

• Published in: Perspectives in clinical research Vol. 14; no. 3; pp. 108 - 113
• Main Authors: Shau, Wen-Yi, Setia, Sajita, Shinde, Salil, Santoso, Handoko, Furtner, Daniel
• Format: Journal Article
• Language: English
• Published: India Medknow Publications and Media Pvt. Ltd 01.07.2023; Medknow Publications & Media Pvt. Ltd; Wolters Kluwer - Medknow; Wolters Kluwer Medknow Publications
• Subjects: asia; Clinical decision making; Clinical outcomes; Clinical trials; Data entry; decision-making; Evidence-based medicine; health technology assessment; Medical research; Medicine, Experimental; Methods; randomized controlled trials; real-world data; real-world evidence; Review; South Asia; Asia; health technology assessment; real-world data; real-world evidence; randomized controlled trials; Asia; decision-making
• ISSN: 2229-3485; 2229-5488
• DOI: 10.4103/picr.picr_193_22

Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs. In addition, few countries in Asia are catching up with the Western world in issuing practical foundational principles and guidance for conducting and adopting evidence for regulatory and reimbursement decisions. However, privacy and data protection laws are generally lagging behind technological developments in electronic medical records. While leveraging RWE in clinical and regulatory decision-making holds excellent potential, collective efforts across industry, governments, and research institutions are required for generating standardized practices and building capabilities for developing fit-for-purpose RWE in Asia.