The management of clinical trials for COVID-19: The importance of Ethics Committees Re: Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK
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Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK
The management of clinical trials for COVID-19: The importance of Ethics Committees Re: Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK
Dear Editor
Since the global outbreak of COVID-19, many Countries have been stuck in the prevention and treatment of this infectious disease. People have to self-isolate at home, cities are blocked, schools, museums and stores are closed.[1] Medical students and retired doctors are convened to resist COVID-19. [2,3] However, there are still no effective drugs or vaccines to be used on COVID-19.
The “Guidance For Managing Ethical Issues In Infectious Disease” published by the World Health Organization (WHO) in 2016 suggests that, during an infectious outbreak, research has an important role in the detection of new strategies for disease prevention, diagnosis and treatment.[4] Therefore, except for current therapeutic and diagnostic methods, more effective drugs and diagnostic strategies should be developed urgently. Despite the urgent situation, clinical trials should not be conducted excessively without supervision. The safety and quality of clinical trials should also be guaranteed.
Up to March 24, 2020, the data of the Chinese Clinical Trial Register (ChiCTR) showed that there were 471 registered items involved with COVID-19. And 143 items registered on ClinicalTrials.gov. [5,6] Such a large number of clinical trials were carried out. There will be many high risk and low benefit drugs being used on COVID-19 patients if Ethics Committees cannot review strictly. Not only will the patients be in danger, but the more meaningful research may lose its chance because the valuable subject resource is taken up. Zhang et al. reported the experience of high efficiency and quality ethical review at one hospital in China and summarized the high frequency issues with the studies.[7] The studies of COVID-19 were reviewed via emergency video conference during the epidemic to avoid crowd gathering. Which ensured the significant research could be implemented scientifically and timely.
Thus, Ethics Committees have a vital role in the review of COVID-19 studies during the outbreak. Especially for intervention studies which might cause physical injury to patients. Ethics Committees not only need to improve the review efficiency, but also make sure the standard of ethical review is not relaxed.
References
1. Elisabeth Mahase. Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK. BMJ 2020;368:m1071.
2. Elisabeth Mahase. Covid-19: medical students to be employed by NHS as part of epidemic response. BMJ 2020;368:m1156.
3. Elisabeth Mahase. Covid-19: UK could delay non-urgent care and call doctors back from leave and retirement. BMJ 2020;368:m854.
4. Guidance for managing ethical issues in infectious disease. World Health Organization website. Published October 27, 2016. Accessed February 2, 2020. https://www.who.int/tdr/news/2016/ethical-issues-in-inf-dis-outbreaks/en/.
5. Chinaclinicaltrials.com. March 24, 2020. http://www.chinaclinicaltrials.com/.
6. U.S. National Library of Medicine. ClinicalTrials.gov. March 24, 2020. https://clinicaltrials.gov/.
7. Hui Zhang, Fengmin Shao, Jianqin Gu, et al. Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic. JAMA. 2020. doi:10.1001/jama.2020.4362.
Rapid Response:
The management of clinical trials for COVID-19: The importance of Ethics Committees Re: Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK
Dear Editor
Since the global outbreak of COVID-19, many Countries have been stuck in the prevention and treatment of this infectious disease. People have to self-isolate at home, cities are blocked, schools, museums and stores are closed.[1] Medical students and retired doctors are convened to resist COVID-19. [2,3] However, there are still no effective drugs or vaccines to be used on COVID-19.
The “Guidance For Managing Ethical Issues In Infectious Disease” published by the World Health Organization (WHO) in 2016 suggests that, during an infectious outbreak, research has an important role in the detection of new strategies for disease prevention, diagnosis and treatment.[4] Therefore, except for current therapeutic and diagnostic methods, more effective drugs and diagnostic strategies should be developed urgently. Despite the urgent situation, clinical trials should not be conducted excessively without supervision. The safety and quality of clinical trials should also be guaranteed.
Up to March 24, 2020, the data of the Chinese Clinical Trial Register (ChiCTR) showed that there were 471 registered items involved with COVID-19. And 143 items registered on ClinicalTrials.gov. [5,6] Such a large number of clinical trials were carried out. There will be many high risk and low benefit drugs being used on COVID-19 patients if Ethics Committees cannot review strictly. Not only will the patients be in danger, but the more meaningful research may lose its chance because the valuable subject resource is taken up. Zhang et al. reported the experience of high efficiency and quality ethical review at one hospital in China and summarized the high frequency issues with the studies.[7] The studies of COVID-19 were reviewed via emergency video conference during the epidemic to avoid crowd gathering. Which ensured the significant research could be implemented scientifically and timely.
Thus, Ethics Committees have a vital role in the review of COVID-19 studies during the outbreak. Especially for intervention studies which might cause physical injury to patients. Ethics Committees not only need to improve the review efficiency, but also make sure the standard of ethical review is not relaxed.
References
1. Elisabeth Mahase. Covid-19: outbreak could last until spring 2021 and see 7.9 million hospitalised in the UK. BMJ 2020;368:m1071.
2. Elisabeth Mahase. Covid-19: medical students to be employed by NHS as part of epidemic response. BMJ 2020;368:m1156.
3. Elisabeth Mahase. Covid-19: UK could delay non-urgent care and call doctors back from leave and retirement. BMJ 2020;368:m854.
4. Guidance for managing ethical issues in infectious disease. World Health Organization website. Published October 27, 2016. Accessed February 2, 2020. https://www.who.int/tdr/news/2016/ethical-issues-in-inf-dis-outbreaks/en/.
5. Chinaclinicaltrials.com. March 24, 2020. http://www.chinaclinicaltrials.com/.
6. U.S. National Library of Medicine. ClinicalTrials.gov. March 24, 2020. https://clinicaltrials.gov/.
7. Hui Zhang, Fengmin Shao, Jianqin Gu, et al. Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic. JAMA. 2020. doi:10.1001/jama.2020.4362.
Competing interests: No competing interests