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

Autor: Shau WY; Medical Affairs, Emerging Asia, Pfizer Corporation Hong Kong Limited, Quarry Bay, Hong Kong., Setia S; Executive Office Transform Medical Communications Limited, Wanganui, New Zealand., Shinde S; Medical Affairs, Emerging Asia, Pfizer Corporation Hong Kong Limited, Quarry Bay, Hong Kong., Santoso H; Medical Affairs, Emerging Asia, Pfizer Corporation Hong Kong Limited, Quarry Bay, Hong Kong., Furtner D; Executive Office Transform Medical Communications Limited, Wanganui, New Zealand.
Jazyk: angličtina
Zdroj: Perspectives in clinical research [Perspect Clin Res] 2023 Jul-Sep; Vol. 14 (3), pp. 108-113. Date of Electronic Publication: 2023 Jun 05.
DOI: 10.4103/picr.picr_193_22
Abstrakt: 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.
Competing Interests: There are no conflicts of interest.
(Copyright: © 2023 Perspectives in Clinical Research.)
Databáze: MEDLINE
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