问答

Q&A

Favorite

Question: Two questions about the clinical trial of COVID-19: 1) At present, the testing and treatment costs of patients are reimbursed by the national or local medical insurance. How to deal with the testing costs of patients participating in the clinical trial of COVID-19? 2) Due to the high false negative rate of test results, the frequency of patient testing is even higher than the protocol requirements, and there are many testing methods (such as nasopharyngeal swabs, sputum, feces, mouthwash, etc.). Considering that the testing methods and conditions vary in different regions, and many patients may experience negative throat swabs but positive sputum culture, etc. If one method is strictly restricted, it may affect judgment, Therefore, there is no clear detection method in the plan. In this case, if paid by the applicant, should all inspections be paid by the applicant

Answer： 1) Whether the sponsor should bear all the costs of the clinical trial process is not clearly defined in the current Chinese GCP and ICH-E6. The current Chinese GCP mentions "the sponsor... provides trial funding", and 4.8.10 in ICH-E6 mentions "The affiliated expenses, if any, to the subject for participating in the trial" regarding informed consent, which means that under ethical conditions, if the subject agrees, the subject is allowed to pay related fees for participating in the trial. According to the COVID-19 prevention and control measures, the government will have funds to support the treatment of COVID-19 patients, and the sponsor only needs to compensate the part of COVID-19 clinical trials that subjects need to pay personally (excluding government support and overall medical insurance). To understand the national measures for epidemic control and protection, please refer to the National Infectious Disease Prevention and Control Law and the management measures for infectious disease prevention and control in each province. 2) The patient screening procedure of the clinical trial should clearly stipulate that in the trial scheme, the sponsor needs to consider and clearly stipulate the diversity of patient screening methods and the instability of the results of the COVID-19 clinical trial mentioned in the question when designing the scheme and evaluating the feasibility, so as to ensure that there is a uniform standard when implementing the scheme.