Version 1
: Received: 17 October 2023 / Approved: 17 October 2023 / Online: 18 October 2023 (18:25:50 CEST)
How to cite:
Chen, Y.; Walters, J.; Bruckner, T. Clinical Trial Registration and Reporting in China and the United States: Legal and Regulatory Frameworks, Compliance and Enforcement. Preprints2023, 2023101108. https://doi.org/10.20944/preprints202310.1108.v1
Chen, Y.; Walters, J.; Bruckner, T. Clinical Trial Registration and Reporting in China and the United States: Legal and Regulatory Frameworks, Compliance and Enforcement. Preprints 2023, 2023101108. https://doi.org/10.20944/preprints202310.1108.v1
Chen, Y.; Walters, J.; Bruckner, T. Clinical Trial Registration and Reporting in China and the United States: Legal and Regulatory Frameworks, Compliance and Enforcement. Preprints2023, 2023101108. https://doi.org/10.20944/preprints202310.1108.v1
APA Style
Chen, Y., Walters, J., & Bruckner, T. (2023). Clinical Trial Registration and Reporting in China and the United States: Legal and Regulatory Frameworks, Compliance and Enforcement. Preprints. https://doi.org/10.20944/preprints202310.1108.v1
Chicago/Turabian Style
Chen, Y., Janie Walters and Till Bruckner. 2023 "Clinical Trial Registration and Reporting in China and the United States: Legal and Regulatory Frameworks, Compliance and Enforcement" Preprints. https://doi.org/10.20944/preprints202310.1108.v1
Abstract
Background and Objectives: Clinical trials are a critical step in the development of new medicines and medical devices, testing the efficacy and safety of new treatment regimens. However, if the results of clinical trials are not made public, the evidence base on interventions is incomplete and possibly distorted, which lead to suboptimal treatment choices and negatively affect public health. This study analyses and contrasts the laws and regulations governing clinical trial registration and reporting in China and the United States. Methods: We used desk research to compile, assess and compare current laws, regulations, compliance patterns, and enforcement mechanisms and actions in China and the United States (U.S.). Policy documents were downloaded from Chinese and U.S. government websites. A spreadsheet analysis was utilized for direct comparison.Results: Both China and the U.S. have laws and regulations governing clinical trial registration and reporting. Chinese legislation covers a broader range of trials. In the U.S. trial results must be disclosed to both the national regulator and the public, while Chinese law mandates disclosure to the regulator alone. Cross-country comparisons of regulatory compliance by trial sponsors are impossible due to the opacity of the Chinese data platform. Neither country effectively ensures that all clinical trial results are made public as required by the Declaration of Helsinki and recommended by the WHO. Interpretation: While neither country is perfect, both may be able to learn from each other. There is a major gap in the literature regarding the extent of non-publication of clinical trial results by sponsors operating in China.
Public Health and Healthcare, Health Policy and Services
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
