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

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.

scholarly journals Characteristics of COVID-19 Clinical Trials in India Based on the Registration Data on CTRI (Clinical Trials Registry- India): a cross-sectional analysis

2020 ◽  
Author(s):  
P Sathiyarajeswaran ◽  
MS Shree Devi ◽  
K Kanakavalli ◽  
NP Vinod
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Multiple Drug ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Registration Data ◽  
Post Marketing Surveillance ◽  
Sectional Analysis

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

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

scholarly journals Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034666 ◽  
Author(s):  
Karolina Strzebonska ◽  
Mateusz T Wasylewski ◽  
Lucja Zaborowska ◽  
Nico Riedel ◽  
Susanne Wieschowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measure ◽  
Cross Sectional Study ◽  
Timely Manner ◽  
Cross Sectional ◽  
Journal Publication ◽  
Cross Sectional Analysis ◽  
Academic Medical ◽  
Study Completion ◽  
Sectional Analysis

ObjectivesTo establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials.DesignCross-sectional study.SettingAMCs in Poland.ParticipantsAMCs with interventional trials registered on ClinicalTrials.gov.Main outcome measureResults reporting on ClinicalTrials.gov and publishing via journal publication.ResultsWe identified 305 interventional clinical trials registered on ClinicalTrials.gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials.gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%).ConclusionsOur cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

scholarly journals A cross sectional analysis on the clinical presentation and outcome of H1N1 influenza patients in a tertiary care hospital in Central Kerala

2019 ◽  
Vol 6 (2) ◽  
pp. 302
Author(s):  
Alvin Treasa George ◽  
Grace George ◽  
David K. Simson ◽  
T. P. Antony
Keyword(s):  
Clinical Presentation ◽  
Tertiary Care ◽  
H1n1 Influenza ◽  
Clinical Profile ◽  
World Health ◽  
Care Hospital ◽  
Cross Sectional ◽  
Presenting Symptoms ◽  
Cross Sectional Analysis ◽  
Sectional Analysis

Background: The World Health Organization raised pandemic H1N1 influenza alert level to phase 6 in June 2009 due to a widespread community transmission on two continents. The recent surge in positive H1N1 cases necessitates a revisit to the clinical profile of the 2009 pandemic. This study was aimed to analyse the clinical profile and outcome of swab positive H1N1 patients.Methods: A cross sectional analysis on the clinical presentation and primary out come in the confirmed H1N1 influenza cases was done. H1N1 confirmation was done using real time reverse transcriptase-Polymerase Chain Reaction in throat swab samples. The data were analysed statistically and presented in percentage.Results: Total 31 cases of severe H1N1 were included in the study. Majority of the cases (16/31) were between15 to 30 yrs of age. Among the total cases, 27 cases were females (87.1%) of which 11 cases were pregnant (35.5%). The predominant presenting symptoms were fever (100%), breathlessness (80.6%), body ache (45.2%), headache (29%) and sore throat (29%). Twenty three of the 31 patients (74.2%) survived while 8 succumbed to the illness (25.8%). All the patients required ICU admission and 8 underwent invasive ventilation. The mortality was high among the ventilated patients (p=0.0064).Conclusions: Pregnancy was associated with higher rate of complications. Early respiratory support did not help in preventing progression to respiratory failure in most of the patients. Vaccination, early recognition of the disease and prompt initiation of treatment appear to be the only way to reduce H1N1 disease progression and mortality.

scholarly journals Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e039978 ◽  
Author(s):  
Hemalkumar B Mehta ◽  
Stephan Ehrhardt ◽  
Thomas J Moore ◽  
Jodi B Segal ◽  
G Caleb Alexander
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
Scientific Progress ◽  
Cross Sectional ◽  
Design Elements ◽  
Cross Sectional Analysis ◽  
Therapeutic Benefits ◽  
Wide Range ◽  
The Usa ◽  
Sectional Analysis

ObjectivesThe coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.Design, setting and participantsCross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.Main outcome(s)Trial intervention, sponsorship, critical design elements and specified outcomesResultsOverall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.ConclusionsWhile accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.

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