Cross-Sectional Analysis of Data from the U.S. Clinical Trials Database Reveals Poor Translational Clinical Trial Effort for Traumatic Brain Injury, Compared with Stroke

AbstractObjectivesThe 2019 pandemic of coronavirus disease (COVID-19) has prompted several efforts to find safe and effective drugs, but little is understood as to where early efforts were centered. Several clinical trials, both Allopathy and AYUSH medicines have been registered in the Clinical Trial Registry of India (CTRI). We aimed to characterize and extract relevant data registered under CTRI for COVID-19.Materials and MethodsA cross-sectional analysis was performed of clinical trials for the treatment of COVID-19 that were registered in the Clinical Trial Registry of India (CTRI) from 1st March 2020 to 22nd June 2020. Relevant trial records were downloaded, deduplicated, and independently analyzed by three reviewers.Main outcomesTrial intervention, design, sponsorship, phase of the trial, and indicated outcomes.Results233 COVID-19 clinical trials, was registered from India in CTRI. Out of these, 146 were Interventional trials, 84 Observational trials, and three Post-marketing surveillance. Questionnaire and survey-based intervention occupy a significant portion. Randomized control trials are large in number 37.8% than non-randomized. 20% of the trials were recruiting patients, and the Research institution (34%) sponsored more than half of the trials. Global trials are minimal, occupying 3% of total trials and Indian trials were 97%. In most of the trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration. Among the trials, 46 Allopathic interventions, 41 Ayurveda interventions, 14 Homeopathy interventions, one in Unani, and 2 in yoga and Naturopathy.ConclusionThis study will provide a background of COVID-19 clinical trials registered in CTRI and provide specific issues observed related to clinical trial designs, which offer information to perform clinical trials on COVID-19

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Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials

BMC Medical Research Methodology ◽

10.1186/s12874-021-01324-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Christopher W. Jones ◽

Amanda C. Adams ◽

Elizabeth Murphy ◽

Rachel P. King ◽

Benjamin Saracco ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

H1n1 Influenza ◽

World Health ◽

Trial Registry ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

2009 H1n1 ◽

Study Completion ◽

Sectional Analysis

Abstract Background Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. Methods This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO’s established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. Results Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16–76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9–34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). Conclusions Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

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Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

Journal of Ayurveda and Integrative Medicine ◽

10.1016/j.jaim.2015.09.003 ◽

2016 ◽

Vol 7 (1) ◽

pp. 48-52 ◽

Cited By ~ 3

Author(s):

S. Kannan ◽

S. Gowri

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

World Health Organization ◽

World Health ◽

Trial Registry ◽

Clinical Trial Registry ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

Health Organization ◽

Sectional Analysis

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Effect of hypoxia on mortality and disability in traumatic brain injury according to shock status: A cross-sectional analysis

The American Journal of Emergency Medicine ◽

10.1016/j.ajem.2018.12.022 ◽

2019 ◽

Vol 37 (9) ◽

pp. 1709-1715 ◽

Cited By ~ 5

Author(s):

Dong Eun Seo ◽

Sang Do Shin ◽

Kyoung Jun Song ◽

Young Sun Ro ◽

Ki Jeong Hong ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

Sectional Analysis

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A cross-sectional analysis of compassion fatigue, burnout, and compassion satisfaction in pediatric surgeons in the U.S.

Journal of Pediatric Surgery ◽

10.1016/j.jpedsurg.2021.01.046 ◽

2021 ◽

Author(s):

Alex Sarosi ◽

Brian A. Coakley ◽

Loren Berman ◽

Claudia M Mueller ◽

Kristy L. Rialon ◽

...

Keyword(s):

Compassion Fatigue ◽

Compassion Satisfaction ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

Sectional Analysis ◽

The U.S

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The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

Journal of Cerebral Blood Flow & Metabolism ◽

10.1177/0271678x18760109 ◽

2018 ◽

Vol 38 (5) ◽

pp. 749-754 ◽

Cited By ~ 1

Author(s):

Olivia Kiwanuka ◽

Bo-Michael Bellander ◽

Anders Hånell

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Clinical Trials ◽

Brain Injury ◽

Network Analysis ◽

Clinical Studies ◽

Phase Iii ◽

Phase Iii Clinical Trial ◽

Phase Iii Clinical Trials ◽

Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

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