The ethics of COVID-19 clinical trials: New considerations in a controversial area

Han, Zhenzhen; Wang, Junting; Zhang, Kai; Tang, Qilin

doi:10.1016/j.imr.2020.100425

Cited by 19 publications

(20 citation statements)

References 14 publications

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“…The ethical review for COVID-19 research at this time occurs under exceptional circumstances. Institutional review boards (IRBs) should particularly consider such issues as strict inclusion and exclusion criteria, participant compensation, and clearly defined risks of the trial to vulnerable patients ( 25 ). Moreover, IRBs must ensure that the standard of ethical review is not relaxed ( 26 ).…”

Section: Institutional Review Board and Ethical Approvalmentioning

confidence: 99%

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Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

et al. 2020

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The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

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Section: Institutional Review Board and Ethical Approvalmentioning

confidence: 99%

“…RCTs are the gold standard for providing efficacy data ( 18 ). During pandemics, the temptation to make unproven therapies widely available and not waiting for rigorous clinical trial data to be generated is understandable ( 25 , 40 ). However, RCTs can be conducted quite rapidly.…”

Section: Clinical Trial Design/conductmentioning

confidence: 99%

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

et al. 2020

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“…50 In terms of research ethics, the research design of COVID-19 trials should not involve reduced ethical review standards. 51,52 There are several shortcomings in this study. First, we included only the results retrieved from ClinialTrials.gov.…”

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confidence: 93%

<p>COVID-19 Clinical Trials Registered Worldwide for Drug Intervention: An Overview and Characteristic Analysis</p>

Wang¹,

Lai²,

Yan³

et al. 2020

DDDT

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“…[ 5 ] Chinese doctors and scientists have conducted many clinical studies on the treatment of COVID-19 with the combination of TCM and western medicine. [ 3 , 6 , 7 ] It is worth noting that most COVID-19 patients in China have received integrated Chinese and western medicine. The comprehensive application of acupuncture, moxibustion, and Chinese herbal medicine has provided new ideas for the treatment and prevention of COVID-19.…”

Section: Introductionmentioning

confidence: 99%

Acupuncture and related interventions for anxiety in coronavirus disease 2019

Jia

Han

Zhang³

et al. 2020

Medicine

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Background: Traditional Chinese medicine plays an irreplaceable role in the treatment and prevention of epidemic diseases in China. Acupuncture is an important part of Chinese medicine. During the coronavirus disease 2019 (COVID-19) epidemic, acupuncture and related interventions are used to treat COVID-19 patients in China. The systematic review aims to evaluate the efficacy and safety of acupuncture and relevant interventions for anxiety in COVID-19. Methods: We will search for randomized control and observational studies of acupuncture and related interventions for anxiety in COVID-19 in the 6 databases from inception to 31 October 2020. There is no language restriction. Two independent reviewers will screen and collect all trials, data extraction and evaluate the risk of bias of the researches. We will perform a meta-analysis if appropriate. Results: Our findings will evaluate the feasibility of acupuncture and related interventions as adjunctive therapy for anxiety in COVID-19 patients, which will be disseminated in a relevant conference and published in a peer-reviewed publication. Conclusion: Our research will appraise the overall quality and evidence of whether acupuncture and related interventions are effective therapies for anxiety in COVID-19.

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The ethics of COVID-19 clinical trials: New considerations in a controversial area

Cited by 19 publications

References 14 publications

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

<p>COVID-19 Clinical Trials Registered Worldwide for Drug Intervention: An Overview and Characteristic Analysis</p>

Acupuncture and related interventions for anxiety in coronavirus disease 2019

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