Follow-up in Clinical Trials of Anti-tumor Drugs after the Normalization of COVID-19’s Prevention and Control: An Investigation Study

Li D and Zhang Y

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), National Drug Clinical Trial Center, China
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Cancer Center, Ward I, Peking University Cancer Hospital & Institute, China

^*Correspondance to: Yan Zhang 

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Abstract:

Background and Objective: After May 2020, the prevention and control of COVID-19 in China has entered precision and normalization period, and sporadic cases appear everywhere. Under these circumstances, we ensure the safety of subjects and their trial drug treatment based on scientific big data and practical measure. At last, most subjects completed the clinical trial drug treatment and data collected according to the protocol, and COVID-19 did not have a significant impact on clinical trials. Methods: The number of new COVID-19 cases per month in China, and subjects visiting on site, mailing drugs, delayed visiting and new enrolled per month in Department of Renal Cancer and Melanoma, Peking University Cancer Hospital were collected from May 2020 to October 2021. The correlation between the number of COVID-19 new cases and the other four items was analyzed. Results: The number of increased COVID-19 cases in China fluctuated every month, followed by the number of subjects mailing drugs and delayed visiting in Department of Renal Cancer and Melanoma. The correlation coefficients are 0.690 and 0.624 respectively (P<0.05). The number of subjects visiting on site and new enrolled increased in fluctuation, which has no obvious correlation with the increased COVID-19 cases. From May 2020 to October 2021, the number of subjects visiting on site was 8366 (98.35%) and 0 subjects withdrew from clinical trials. Conclusion: Relying on scientific big data and practical measures, subjects' visiting on Department of Renal Cancer and Melanoma and enrolling didn't affect by COVID-19 greatly. The number of drug mailing and delayed visiting accounted for small proportion. The data collection is effective, and COVID-19 will not have a significant impact on clinical trials carried out in Department of Renal Cancer and Melanoma.

Keywords:

Clinical trials; Subjects; Follow-up; COVID-19; Investigation

Cite the Article:

Li D, Zhang Y. Follow-up in Clinical Trials of Anti-tumor Drugs after the Normalization of COVID19’s Prevention and Control: An Investigation Study. World J Surg Surgical Res. 2023; 6: 1475..