OBJECTIVES: The purpose of medical interventions is to better patients' lives, necessitating an understanding of their experiences, needs, and priorities. In this context, Clinical Outcome Assessments (COAs) serve a crucial role within clinical trials. However, standards for COAs differ across countries, reflected in their distinct drug approval guidelines. This study compares the incorporation of COAs in the guidelines of China, Japan, and India.

METHODS: We utilized a conceptual thematic analysis of the guidelines: China's patient-centered clinical trial design issued by the National Medical Products Administration (NMPA), Japan's Pharmaceutical and Medical Devices Agency (PMDA) guidelines, and India's drug approval guidelines. Our focus was on the content comparison of these guidelines concerning the application, evaluation, and articulation of COA standards aiding regulatory decisions.

RESULTS: The analysis unveiled a more detailed elaboration of COA content in China's guidelines compared to Japan's and India's. Integral COA aspects such as measure selection, patient involvement in study design, and assessment of respondent burden are distinctly outlined in Chinese guidelines. China also emphasizes COA-based endpoint considerations in its regulations. In contrast, Japan and India lack similarly detailed, nation-specific data, leaning heavily on US and EU regulatory guidelines instead. Despite COA modules being considered during clinical trial protocol approval in both countries, explicit mention of COAs in their guidelines is lacking.

CONCLUSIONS: China exemplifies substantial progress in establishing patient-centric clinical trial design with COA integration. However, comparable advancements are yet to be seen in other APAC regions like Japan and India. Future efforts should concentrate on APAC collaboration to implement COA guidelines, factoring in participants' literacy, technological capabilities, cultural, and personal needs. This would foster a more tailored, patient-centric approach in clinical trials across these culturally diverse nations.