OBJECTIVES

The heterogeneity of real-world studies (RWS) makes it challenging to assess its conduct and adequacy of reporting. This research aims to examine the trends of oncology studies conducted in real-world settings in Southeast Asia (SEA) and systematically identify and appraise the quality of these studies.

METHODS

We defined real-world evidence (RWE) as one generated using routinely collected real-world data. We searched MEDLINE and Embase for peer-reviewed articles published in English from 2010 to 2019. Countries of interest include all Southeast Asian countries, namely, Brunei, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. We excluded studies investigating the cost-effectiveness of interventions and cross-sectional patient surveys but included population health surveys.

RESULTS

Of the 3384 studies that included the use of real-world data, 368 (11%) of the articles focused on oncology. Half of these articles (50%) were published between 2015 and 2019. Approximately 29% and 27% of the studies were conducted in Thailand and Singapore, respectively. The prevailing study design was cohort study (38%). Only 14% of the studies were specific to a product or molecule. The most commonly used data sources include hospital medical records (34%) and registries (14%). All studies described the characteristics of the participants or patients and study methodology, but there were limitations that impaired the interpretability of these studies. These included incomplete reporting according to the STROBE guidelines, unclear comparator, lack of ethics review, inadequate management of missing data, biases and confounders, and limited generalizability with single-center studies and small sample sizes.

CONCLUSIONS

We found sub-optimal conduct and reporting in a considerable number of RWS in SEA. Sharing best practices for evidence generation and monitoring the quality and reporting of these studies will be critical to improving the credibility of RWS in SEA.