ABSTRACT
Background: To examine the outcomes heterogeneity of clinical trial protocols of coronavirus disease 2019 (COVID-19) to prioritize the establishment of a core outcome set. Methods: Databases of the International Committee of Medical Journal Editors - accepted clinical trial registry platforms were searched on February 14, 2020 and May 31, 2020. Randomized controlled trials and non-randomized controlled trials of COVID-19 were considered. Patient condition was classified as common, severe, or critical. Interventions included traditional Chinese medicine and Western medicine. We excluded trials that involved discharged patients, psychological intervention, and complications of COVID-19. The general information and outcomes, outcome measurement instruments, and measurement times were extracted. The results were analyzed by descriptive analysis. Results: In all, 19 registry platforms were searched. A total of 97 protocols were selected from among 160 protocols for the first search. For protocols of traditional Chinese medicine clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of the outcomes were reported only once;the most frequently reported outcome was time taken for severe acute respiratory syndrome coronavirus 2 RNA to become negative. Twenty-seven (27/76, 35.53%) outcomes provided one or more outcome measurement instruments. Ten outcomes provided one or more measurement time frame. For protocols of Western medicine clinical trials, 126 outcomes from 17 outcome domains were reported;almost half (62/126, 49.21%) of the outcomes were reported only once;the most frequently reported outcome was proportion of patients with negative severe acute respiratory syndrome coronavirus 2. Twenty-seven outcomes provided one or more outcome measurement instruments. Forty (40/126, 31.75%) outcomes provided one or more measurement time frame. There were > 40 duplicated outcomes between the clinical trials protocols of traditional Chinese medicine and western medicine protocols. All of them were included in the Delphi survey when developing core outcome set for COVID-19. A total of 1,027 protocols were selected from 2,741 protocols for the second search. Forty-two new outcomes and 47 new outcome measurement instruments were reported. Conclusion: Outcome reporting in clinical trial protocols of COVID-19 is inconsistent. Thus, establishing a core outcome set is necessary for diagnosis and management.
ABSTRACT
A large number of traditional Chinese medicine (TCM) prescriptions have played an active role in the prevention and treatment of emerging epidemic diseases, which contain huge potential of research and development (R&D). However, in recent years, few TCM new drugs have been approved for market and the industry is in a downturn. With examples of the recent drug review policies and the "three Chinese patent medicines and three TCM prescriptions" for Corona Virus Disease 2019 (COVID-19), this article proposed a series of strategies from the perspectives of review and R&D of TCM new drugs as well as resource allocation. The strategies are improving the R&D layout of TCM new drugs, clarifying the evaluation criteria of human experience evidence, supervising the syndrome indications for TCM new drugs other than diseases, implementing differentiation competitive strategy, applying multi-disciplinary methods in prescription screening, applying integrated research design, increasing investment in high-quality clinical research, and integrating resources to break through international barriers. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved.