Abstract 575P
Background
Cancer is a leading cause of mortality worldwide with oncology products receiving the highest number of novel drug approvals in recent years. There is increasing interest in leveraging real-world evidence to contextualize and/or enhance generalizability of clinical trial outcomes. As nearly 50% of the global cancer burden is in Asia, we sought to clarify the current landscape of non-interventional oncology studies in this geographical area by analyzing information submitted to clinical trial registries.
Methods
We searched for non-interventional oncology studies in phase 0, phase 4 and post-marketing (PMS) categories across ten Asian countries (China, India, Indonesia, Japan, Malaysia, Philippines, Republic of Korea, Singapore, Thailand and Vietnam) using the International Clinical Trials Registry Platform (ICTRP). Studies recruited in the last 5 years (1 January 2019 to 31 December 2023) were included. The number of non-interventional studies per year and their characteristics (e.g., study phase, indication and cohort types) were extracted and compared between countries.
Results
In total, 752 studies were identified across the ten countries of interest. Except for four studies conducted in multiple countries (0.5%), all the remaining studies (99.5%) were conducted in China, India, Thailand or Japan. China accounted for 97.2% of all registrations, although these numbers declined in the past five years with the highest registration in 2021. Of the registrations from China, 73.9% were phase 0 studies and 33.5% were prospective studies with similar studies reported in Thailand (2, 100%) and Japan (1, 12.5%). Lung cancer and gastrointestinal cancer were the most frequent research foci in China and Japan. All multinational studies were for breast cancer and included Japan, India, Vietnam, Taiwan, Türkiye and Western Asia countries as study locations.
Conclusions
Characteristics of non-interventional cancer studies varied across the ten Asian countries of interest. Although ICTRP includes clinical research information from major national databases in Asia, a considerable number of phase 0 and 4 studies from countries other than China seems unrecorded. Therefore, we recommend that registration to international clinical trial database should be encouraged at a national level.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Syneos Health.
Funding
Has not received any funding.
Disclosure
M. Matsuo, D. Baik, F. Scaramozzino, R. Miller, S. Kim, C. Vossen: Financial Interests, Personal, Full or part-time Employment: Syneos Health.