Implications of the lack of a unified research project framework: an investigation into the registration of clinical trials of COVID-19

Wang, Bin; Lai, Junkai; Yan, Xiaoyan; Jin, Feifei; Yao, Chen

doi:10.1080/03007995.2020.1771294

Cited by 4 publications

(7 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The global spread of the epidemic has given researchers more time to prepare their studies. Compared with previous studies, 3 our results show that the proportion of randomization increased from 71% to 94.5%, while the blinding rate increased from 5% to 52.2%. The increase in these numbers reflects the importance global researchers now place on the design quality of clinical drug trial for COVID-19.…”

contrasting

confidence: 85%

“…For example, when the outbreak first appeared in China, the clinical studies registered by some researchers on the Chinese Clinical Trial Registry (http://www.chictr.org.cn) had many design quality problems, such as a lack of blinding, replicated research, small sample sizes, and unreasonable main outcome indicators. 3 Although retractions of clinical studies receive proper attention from researchers, 4 this has been amplified for clinical studies on COVID-19. 5,6 In addition, there is persistent controversy regarding the results of some COVID-19 drug trials, such as those investigating angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (ACEIs/ARBs), 7 hydroxychloroquine, 8 and chloroquine.…”

Section: Discussionmentioning

confidence: 99%

“…Due to this misunderstanding, previous studies have suggested that COVID-19 clinical trials registered before March 2020 have many study design defects, such as a lack of blinding. 3 As the epidemic has spread throughout the world and a total of 3000 clinical research studies have been registered on the American Clinical Trials Registry (ClinialTrials.gov), an evaluation of the characteristics of studies investigating registered drug interventions is needed. 2 Therefore, the purpose of this study is to comprehensively evaluate the characteristics of clinical trials with at least one drug intervention registered on ClinialTrials.gov to facilitate the collection of evidence for the efficacy of COVID-19 drug treatments.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Wang¹,

Lai²,

Yan³

et al. 2020

DDDT

Self Cite

View full text Add to dashboard Cite

contrasting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Wang¹,

Lai²,

Yan³

et al. 2020

DDDT

Self Cite

View full text Add to dashboard Cite

“…The selection of the reference group is complex since some pre-existing conditions and the time since the appearance of the symptoms are the main determinants of the outcomes, including survival. The use of a placebo has been eliminated in many trials based on the absence of an effective therapy 5 . However, the proper allocation of side effects implies the use of a placebo in controlled studies 6 .…”

Section: Accurate Versus Fast-moving Informationmentioning

confidence: 99%

Bioethics in the COVID-19 Pandemic Research: Challenges and Strategies

González‐Duarte

Kaufer‐Horwitz

Aguilar-Salinas

2021

RIC

View full text Add to dashboard Cite

As all other aspects in times of the coronavirus disease (COVID)-19 pandemic, carrying-out quality clinical research has been challenging. Many well-established paradigms have shifted as a consequence of the rapid demand for new knowledge. New treatments are fast-moving, informed consent forms are difficult to obtain, a competitive invitation from researchers to participate in different studies is common, and non-COVID-19 research protocols are suffering continuity. However, these challenges should not imply taking shortcuts or accepting deficiencies in bioethical standards, but rather enhance the alertness for rigorous ethical approaches despite these less than ideal circumstances. In this manuscript, we point out some interrogates in COVID-19 research and outline possible strategies to overcome the difficult task to continue with high-quality research without violating the ethical principles. (REV INVEST CLIN. [AHEAD OF PRINT]

show abstract

“…The rush to conduct research during the COVID-19 crisis may compromise research quality and rigour. Several papers have highlighted issues with the emerging research landscape [1][2][3][4][5][6][7], including in clinical trials [1,8,9]. However, suboptimal trial design is common outside of pandemics (e.g.…”

Section: Introductionmentioning

confidence: 99%

Estimating the effect of COVID-19 on trial design characteristics: a registered report

et al. 2023

View full text Add to dashboard Cite

There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1 : 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB . This pre-registration was performed prior to data analysis.

show abstract

Implications of the lack of a unified research project framework: an investigation into the registration of clinical trials of COVID-19

Cited by 4 publications

References 7 publications

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

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

Bioethics in the COVID-19 Pandemic Research: Challenges and Strategies

Estimating the effect of COVID-19 on trial design characteristics: a registered report

Contact Info

Product

Resources

About