Analysis of Registered Clinical Trials in The WHO International Clinical Trials Registry Platform, 2005-2019: A Cross-section Study (Preprint)

2020 ◽  
Author(s):  
Fei Zhao ◽  
Wei Xue ◽  
Wenyuan Qi ◽  
Duanduan Cong ◽  
Huiqing Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Middle Income ◽  
Middle Income Countries ◽  
Increasing Trend ◽  
Clinical Trials Registry ◽  
Over Time ◽  
Trial Performance

BACKGROUND Background: World health organization and the international committee of medical journal editors call for clinical trial registration before the start of the recruitment of participants. The registration promotes transparency and accessibility to all researchers and targeted patients globally. OBJECTIVE Objective: We conducted this research to explore the tendency and change of clinical trial registration among different classifications, in order to show the development of the registered clinical trials in the world. METHODS Methods: All clinical trials which had registered in the database of the International Clinical Trials Registry Platform (ICTRP) from 2005 to 2019 were collected as the database for analysis in this study. Developments of clinical trial registration were analyzed in terms of different registries, different regions, different income country classifications by covariance analysis for the difference in clinical trial registration and Cochran-Armitage Test for trend. The sample size enrolled was analyzed to explore whether there was any change in the scale of the clinical trials over time. RESULTS Results: Totally 205,228 clinical trials were registered in the ICTRP from 2005 to 2019. The numbers of clinical trial implementation annually increased as an exponential function (R2=0.83，t=10.45，P< .001). Almost 65% of clinical trials were performed in North American and East Asia & Pacific regions. There was a significant increasing trend in the numbers of clinical trial performance over time (F=184.85, P< .001). The numbers of clinical trial registration were different significantly between different income classifications of the country (F=90.84, P< .001). The sample sizes of the same Phases of clinical trials had no significant difference adjusted by income classification over time changes (F=0.57, P= .45). CONCLUSIONS Conclusions: The clinical trials were becoming flourishing in the world. Most of the clinical trials had performed in high and upper-middle-income countries, especially North American and East Asia & Pacific. And the lower-middle-income countries had a much faster-increasing trend in the clinical trial performance.

scholarly journals Updated Analysis of Pediatric Clinical Trials Registered in ClinicalTrials.gov, 2008-2019

2021 ◽  
Author(s):  
Yang Zhong ◽  
Li-jun Zhou ◽  
Lei Li ◽  
Tao Zhang ◽  
Xingyu Zhang
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Missing Data ◽  
Small Scale ◽  
Clinical Trial Registration ◽  
Clinical Trial Results ◽  
Data Elements ◽  
Study Type ◽  
Clinical Trials Registry ◽  
Over Time

Abstract Background Since the national clinical trials registry (ClinicalTrials.gov) launched in February 2000, more than 300,000 trials have been registered. However, little is known about the registered pediatric clinical trials with regarding to characteristics, trends and quality over time.Methods To describe patterns of the registered pediatric clinical trials, a dataset of trials involving children was downloaded from ClinicalTrials.gov on August 1st, 2020. To further trace the registration of pediatric disease types, we selected the top four infectious diseases to describe their trends over time. To examine reporting completion rate of clinical trial results, we identified completed studies and then observed the proportion of trials subject to reporting.Results Between 2000 and 2019, a total of 53,060 pediatric trials were registered at ClinicalTrials.gov, including 36,136 (68.1%) interventional trials and 6,692(31.5%) observational trials. The number of them increased significantly over time. Meanwhile, the number of missing data elements has generally declined.Most interventional pediatric trials were single center (61.4%), small-scale(58.9%), randomized (66.0%), and none masking(56.9%), with fewer drug trials being conducted over time.Many pediatric clinical trials were funded by other organizations.The proportion of trials complianced with reporting results varied by study type, trial phase and lead sponsor.Conclusion The pediatric clinical trial registration are on the rise, with significant changes in registration information such as trial type, main purpose, and intervention characteristics, which can help stakeholders inform the decision to conduct trials in children. Although the proportion of missing data was decreasing, the proportion of reporting results remained to be improved.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals

2013 ◽  
Vol 29 (6) ◽  
pp. 1095-1100 ◽  
Author(s):  
Ludovic Reveiz ◽  
Eleana Villanueva ◽  
Chimaraoke Iko ◽  
Iveta Simera
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latin American ◽  
Randomized Clinical Trials ◽  
Reporting Guidelines ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Biomedical Journals ◽  
The Caribbean ◽  
Latin American And Caribbean

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

scholarly journals Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017246 ◽  
Author(s):  
Samuel R P Franzen ◽  
Clare Chandler ◽  
Sisira Siribaddana ◽  
Julius Atashili ◽  
Brian Angus ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Necessary Conditions ◽  
Evidence Based ◽  
Middle Income ◽  
Trial Conduct ◽  
Middle Income Countries ◽  
Barriers And Enablers ◽  
Research Systems ◽  
Clinical Trial Conduct

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

scholarly journals Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Jalemba Aluvaala ◽  
Lucy Bradshaw ◽  
Jane P Daniels ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Global Health ◽  
Good Clinical Practice ◽  
Research Experience ◽  
Middle Income ◽  
Middle Income Countries ◽  
Training Package

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

scholarly journals Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019983 ◽  
Author(s):  
Kylie Elizabeth Hunter ◽  
Anna Lene Seidler ◽  
Lisa M Askie
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Zealand ◽  
Random Sample ◽  
Descriptive Analysis ◽  
Perceived Usefulness ◽  
Trial Registration ◽  
Industry Type ◽  
Complete Dataset ◽  
Clinical Trials Registry

ObjectivesTo analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration.DesignPart 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey.ParticipantsPart 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015.Main outcome measuresPart 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance.ResultsPart 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration.ConclusionsDespite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance.

scholarly journals Visualization analysis of the characteristics of COVID-19 clinical trials

2020 ◽  
Author(s):  
Xiaoqiong Cai ◽  
Zengliang Zheng ◽  
Jihan Huang ◽  
Qianmin Su
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Endpoint ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Trial Registration ◽  
Developmental Trend ◽  
Integrated Medicine ◽  
Multiple Sources ◽  
Clinical Trial Registration

Abstract Background As a highly contagious disease, COVID-19 is raging on and is faced by every human being. Clinical trials are one of the most important means of investigating treatments for COVID-19, and their effective implementations may address the massive spread of the pandemic. As clinical trials continue to be conducted, the inability to view large amounts of data at a glance becomes a problem for many researchers. In order to provide reference and assistance for clinical trial design, this study collected and analyzed the current COVID-19 clinical trial registration data from multiple sources, and subsequently discussed their research status and developmental trend. Method The registered data of COVID-19 clinical trials were gathered from the ChiCTR and ClinicalTrials.gov website, which were transformed by Python and further demonstrated by Apache ECharts. Results As of March 28, 2020, records of 677 eligible registered trials had been retrieved. Overall, there are 407 (60.12%) interventional studies and 270 (39.12%) observational studies; 522 (77.10%) trials were conducted by hospitals; 53.32% of trials would be completed within six months; 523 (77.25%) subjects in trials were confirmed cases. Among interventional studies, 70.27% of the trials were randomized parallel studies; 55 (13.51%) trials considered time condition for clinical recovery as the primary endpoint, and 46 (11.30%) trials through clinical parameters and laboratory index as the primary endpoint. In the selection of intervention measures, chemical or biological agents constituted 43.49%, of which antiviral ones accounted for 14.50%, and antimalarials accounted for 8.85%, and 98 (24.14%) cases of studies involving TCM or integrated medicine. In addition, this study further analyzed antiviral drugs and explored possibilities of using combined drugs. Although a large number of clinical trials are already underway, interim research data will be helpful for future trial design and drug selection. Conclusions By compiling representative information of topical COVID-19 clinical trial registration, this study complements and enhances the effects of future researchers' trial designs.

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