Integrated Real-World Study Databases in 3 Diverse Asian Health Care Systems in Taiwan, India, and Thailand: Scoping Review

Background The use of real-world data (RWD) warehouses for research in Asia is on the rise, but current trends remain largely unexplored. Given the varied economic and health care landscapes in different Asian countries, understanding these trends can offer valuable insights. Objective We sought to discern the contemporary landscape of linked RWD warehouses and explore their trends and patterns in 3 Asian countries with contrasting economies and health care systems: Taiwan, India, and Thailand. Methods Using a systematic scoping review methodology, we conducted an exhaustive literature search on PubMed with filters for the English language and the past 5 years. The search combined Medical Subject Heading terms and specific keywords. Studies were screened against strict eligibility criteria to identify eligible studies using RWD databases from more than one health care facility in at least 1 of the 3 target countries. Results Our search yielded 2277 studies, of which 833 (36.6%) met our criteria. Overall, single-country studies (SCS) dominated at 89.4% (n=745), with cross-country collaboration studies (CCCS) being at 10.6% (n=88). However, the country-wise breakdown showed that of all the SCS, 623 (83.6%) were from Taiwan, 81 (10.9%) from India, and 41 (5.5%) from Thailand. Among the total studies conducted in each country, India at 39.1% (n=133) and Thailand at 43.1% (n=72) had a significantly higher percentage of CCCS compared to Taiwan at 7.6% (n=51). Over a 5-year span from 2017 to 2022, India and Thailand experienced an annual increase in RWD studies by approximately 18.2% and 13.8%, respectively, while Taiwan’s contributions remained consistent. Comparative effectiveness research (CER) was predominant in Taiwan (n=410, or 65.8% of SCS) but less common in India (n=12, or 14.8% of SCS) and Thailand (n=11, or 26.8% of SCS). CER percentages in CCCS were similar across the 3 countries, ranging from 19.2% (n=10) to 29% (n=9). The type of RWD source also varied significantly across countries, with India demonstrating a high reliance on electronic medical records or electronic health records at 55.6% (n=45) of SCS and Taiwan showing an increasing trend in their use over the period. Registries were used in 26 (83.9%) CCCS and 31 (75.6%) SCS from Thailand but in <50% of SCS from Taiwan and India. Health insurance/administrative claims data were used in most of the SCS from Taiwan (n=458, 73.5%). There was a consistent predominant focus on cardiology/metabolic disorders in all studies, with a noticeable increase in oncology and infectious disease research from 2017 to 2022. Conclusions This review provides a comprehensive understanding of the evolving landscape of RWD research in Taiwan, India, and Thailand. The observed differences and trends emphasize the unique economic, clinical, and research settings in each country, advocating for tailored strategies for leveraging RWD for future health care research and decision-making. International Registered Report Identifier (IRRID) RR2-10.2196/43741

To support the benefits of RWE in Asian healthcare strategy, planning and policy, we identified linked contemporary databases used in real-world studies in three representative countries in Asia by performing a systematic scoping review. 4 The collection of real-world evidence (RWE) is increasingly crucial in Asia Only ~17% of clinical trials are conducted in Asia, and Asian populations are often under-represented in pivotal clinical trials.*These economies were defined according to the World Bank analysis for the 2023 fiscal year, whereby low-income economies are those with a gross national income (GNI) per capita, calculated using the World Bank Atlas method, of $1,085 or less in 2021; lower-middle-income economies are those with a GNI per capita between $1,086 and $4,255; upper-middle-income economies are those with a GNI per capita between $4,256 and $13,205; high-income economies are those with a GNI per capita of $13,205 or more (World Bank country and lending groups.The World Bank Group.URL: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups) .

Diverse health-care reimbursement in Asia
Asia is a very diverse region.We chose a representative country for three economies in Asia.*

Scoping Data
The PubMed search strategy covered three concepts Concept 1 was designed to identify potential RWE/RWD studies by applying a variety of MeSH terms ("Treatment Outcome", "Evidence-Based Medicine", "Retrospective Studies", "Time Factors") and related keywords (e.g."real-world", "actual life", "actual practice").
Concept 2 introduced the three countries (India, Taiwan, and Thailand).

01
These searches were combined with filters for the English language and publications in the last 5 years before the search

Data Extraction Screening 02
The retrieved articles underwent Phase 1 (title and abstract) and Phase 2 (full text) screening phases 03 Data extraction of eligible citations are done using Covidence software.
The study protocol and methodology adhered to the PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines.

Inclusion and exclusion criteria for eligible citations retrieved from PubMed
*Publications with prospective descriptions of a handful of patient cases; retrospective case series with a real-world data study design 2 were eligible for inclusion (Glen S. "Retrospective Study: Case-Control and Case-Series" From StatisticsHowTo.com:Elementary Statistics for the rest of us! Available from: https://www.statisticshowto.com/retrospective-study/)Abbreviations: PCTs, pragmatic clinical trials; RCTs, randomised controlled trials References: 1. Shau WY, Setia S, Shinde SP, Santoso H, Furtner D. Contemporary Databases in Real-world Studies Regarding the Diverse Health Care Systems of India, Thailand, and Taiwan: Protocol for a Scoping Review.JMIR Res Protoc.2022 Dec 13;11(12):e43741.

Inclusion criteria Exclusion criteria
Database types

Study types
All types of real-world studies or their protocols using the following databases were included: • Electronic health records • Health insurance/administrative claims

Scope of publication
Studies with databases involving Taiwan, India, or Thailand.Eligible international/regional/multi-country studies were included, provided any of the target countries were included Studies with a scope outside Taiwan, India, or Thailand were excluded

RWE provides certainty about the safety and effectiveness of medications, health interventions and technologies in the local setting for Asian patients. 1 Unmet needs remain in increasing the adoption of RWE in Asia to support regulatory and clinical decision- making. 3 Generating fit-for-purpose real-world evidence in Asia
1,2 References: 1. Shau WY, Setia S, Shinde SP, Santoso H, Furtner D. Contemporary Databases in Real-world Studies Regarding the Diverse Health Care Systems of India, Thailand, and Taiwan: Protocol for a Scoping Review.JMIR Res Protoc.2022 Dec 13;11(12):e43741.

economies in Asia Contemporary databases for real-world studies of three diverse healthcare systems in Asia Scoping review for India, Thailand, and Taiwan METHODOLOGY Methodology
Taiwan Thailand India High-income economy Upper-middle-income economy Lower-middle income economy Health insurance for universal coverage and a single social health insurance scheme exists Health insurance for universal coverage with differential de-centralised benefit packages Largely a self-pay healthcare system Diverse Abbreviations: RCT, randomized controlled trial; RWD, real-world data; RWE, real-world evidence References: 1. Shau WY, Setia S, Shinde SP, Santoso H, Furtner D. Contemporary Databases in Real-world Studies Regarding the Diverse Health Care Systems of India, Thailand, and Taiwan: Protocol for a Scoping Review.JMIR Res Protoc.2022 Dec 13;11(12):e43741.