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 Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias.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 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 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 Publish or perish: reporting characteristics of peer-reviewed publications, pre-prints and registered studies on the COVID-19 pandemic

2020 ◽  
Author(s):  
S Gianola ◽  
TS Jesus ◽  
S Bargeri ◽  
G Castellini
Keyword(s):  
Clinical Trial ◽  
Systematic Reviews ◽  
Case Reports ◽  
Time Frame ◽  
Trial Registry ◽  
Medical Subject Headings ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Publish Or Perish ◽  
Print Publications

AbstractBackgroundThe COVID-19 pandemic has resulted in a mass of academic papers being published in a very brief span of time. Our aim was to compare the amount and reporting characteristics of COVID-19 related peer-reviewed and pre-prints publications. We also investigated the amount of ongoing trials and systematic reviews.Methods and findingsA cross-sectional study of publications covering the COVID-19 pandemic time frame, up to May 20, 2020 was conducted. PubMed with appropriate combinations of Medical Subject Headings and COVID-19 section of MedRxiv and BioRxiv archives were searched. We examined Clinicaltrial.gov, Chinese Clinical Trial Registry, EU Register and 15 other trial registers as well as the international prospective register of systematic reviews (PROSPERO). Characteristics of each publication source were extracted. Regression analyses and Z tests were used to analyze publication trends over the weeks and compare their relative proportions.We found 3635 peer-reviewed publications and 3805 pre-prints, of which 8.6% (n=329) were published in indexed journals. Peer-reviewed and pre-print publications amount both increased significantly over time (p<0.001). Case reports (peer-reviewed: 6% vs pre-prints: 0.9%, p<0.001) and letters (17.4% vs 0.5%, p<0.001) accounted for a greater share of the peer-reviewed compared to pre-print publications. In turn, randomized controlled trials (0.22% vs 0.63% p<0.001) and systematic reviews (0.08% vs 5%) accounted for a significantly greater share of the pre-print publications. Clinicaltrials.gov, Chinese Clinical Trial Registry and EU register included 57.9%, 49.5 % and 98.9% trials mostly still “recruiting”. PROSPERO amounted to 962 systematic review protocols.ConclusionPre-prints were slightly more prevalent than peer-reviewed publications, yet both are growing. To fill the void given by the absence of published primary studies, immediate opinions (i.e., letters) has virulently been published in PubMed. However, preprints has been promoted as rapid responses to give direct and promptly access at scientific findings in this pandemic.

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.

Guidance for reporting clinical trial registry records and published protocols use in systematic reviews of interventions

2019 ◽  
Author(s):  
Julia Bidonde ◽  
Jose Francisco Meneses-Echavez ◽  
Angela Jean Busch ◽  
Catherine Boden
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Systematic Reviews ◽  
Cochrane Collaboration ◽  
Subject Area ◽  
Selective Reporting ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Reporting Practices ◽  
Starting Point

Abstract Background: Transparency is a tenet of systematic reviews. Searching for clinical trial registry records and published protocols has become a mandatory standard when conducting a systematic review of interventions. However, there is no comprehensive guidance for review authors on how to report the use of registry records and published protocols in their systematic review. The objective of this study was to generate initial guidance to assist authors of systematic reviews of interventions in the reporting of registry records and published protocols in systematic reviews of interventions. Methods: We used a compilation of the procedures recommended by expert organizations (e.g., Cochrane Collaboration) related to the reporting of use of registry records and published protocols in the conduct of systematic reviews. The compilation was developed by one of the authors in this study and served as a starting point in developing the algorithm. We extracted current practice data related to registry records and published protocols from a stratified random sample of Cochrane systematic reviews of interventions published between 2015 and 2016 (n=169). We identified examples that adhered to or extended the current guidance. Based on the on the elements above, we created the algorithm to bridge gaps and improve current reporting practices. Results: Trial protocols should be used to account for all evidence in a subject area, evaluate reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates. Review authors’ terminology (e.g., ongoing, terminated) and consequent reporting in the review should reflect the phase of the trial found. Protocols should be clearly and consistently reported throughout the review (e.g. abstract, methods, results) as is done with published articles. Conclusions: Our study expands on available guidance to describe in greater detail the reporting of registry records and published protocols for review authors. We believe this is a timely investigation that will increase transparency in the reporting of trial records in systematic reviews of interventions and bring clarification to current fuzziness in terminology. We invite researchers to provide feedback on our work for its improvement and dissemination. Trial Registration: not applicable

The Radiotherapy Clinical Trial Research Landscape in the UK Between 2004 and 2013: A Cross-sectional Analysis

2015 ◽  
Vol 27 (9) ◽  
pp. 491-494 ◽  
Author(s):  
C.M. Evans ◽  
N.G. Burnet ◽  
E. Hall ◽  
R.A. Huddart ◽  
C.M. Nutting ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cross Sectional ◽  
Clinical Trial Research ◽  
Cross Sectional Analysis ◽  
The Uk ◽  
Sectional Analysis
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