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 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 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 Progress in trial registration in Latin America and the Caribbean, 2007–2013

2017 ◽  
Vol 41 ◽  
pp. 1 ◽  
Author(s):  
Pablo Rodríguez-Feria ◽  
Luis Gabriel Cuervo
Keyword(s):  
Clinical Trial ◽  
Latin America ◽  
Trial Registration ◽  
World Health ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Publication Rates ◽  
Clinical Trial Registries ◽  
The Caribbean ◽  
Health Organization

This descriptive study identifies trends in clinical trial registration in the World Health Organization International Clinical Trial Registry Platform (ICTRP) for Latin America and the Caribbean (LAC), from 2007–2013, and provides adjusted estimates for registration rates by population and publications (2007–2011). Trends and data are presented by subregion and language in interactive graphs, including annual registration rates by population (2007–2011) and publications (LILACS and MEDLINE) listed in SCIENTI Network (Science and Technology Indicators). Of the 11 945 clinical trials involving LAC countries, 8 282 were in South America, with Brazil leading at 4 070 (49%); 2 421 in North and Central America, with Mexico leading at 1 886 (78%); and 1 242 in the Caribbean, with Puerto Rico leading at 857 (69%). After adjusting by population and publication rates Chile, Panama, Argentina, and Peru led registration rates per 1 million inhabitants. Variations in the number of trials per year are quite substantial. Clinical trial registration increased in a steady yet inconsistent way. The implementation of the Policy on Research for Health has been followed by an increase in countries that require registration and have established clinical trial registries. However, there is room for improvement in adherence throughout LAC. Trial registration is offered gratis by Brazilian, Cuban, Peruvian, and United States registries, among others.

scholarly journals Clinical Trial Registration in Physical Therapy Journals: A Cross-Sectional Study

2014 ◽  
Vol 94 (1) ◽  
pp. 83-90 ◽  
Author(s):  
Abraham Samuel Babu ◽  
Sundar Kumar Veluswamy ◽  
Pratiksha Tilak Rao ◽  
Arun G. Maiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Physical Therapy ◽  
Prospective Trial ◽  
Theory And Practice ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Editorial Policies ◽  
Journal Editors

Background Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. Objective The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. Design This study was carried out using a cross-sectional design. Methods Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Results Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. Limitations The study was limited to MEDLINE-indexed ISPJE member journals. Conclusions Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show greater commitment to prospective trial registration to make it a rule rather than an option.

Adherence to reporting guidelines and clinical trial registration policies in oncology journals: a cross-sectional review

2018 ◽  
Vol 23 (3) ◽  
pp. 104-110 ◽  
Author(s):  
Cole Wayant ◽  
Gretchan Moore ◽  
Mark Hoelscher ◽  
Courtney Cook ◽  
Matt Vassar
Keyword(s):  
Clinical Trial ◽  
Observational Studies ◽  
Quality Standards ◽  
Reporting Guidelines ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Specific Guideline ◽  
Trial Outcomes ◽  
Quality Study

Reporting guidelines (RG) aim to improve research transparency and ensure high-quality study reporting. Similarly, clinical trial registration policies aim to reduce bias in results reporting by ensuring prospective registration of all trial outcomes. Failure to adhere to quality standards documented in RGs may result in low-quality and irreproducible research. Herein, we investigate the adherence to common RGs and trial registration policies in 21 oncology journals. We surveyed the Instructions for Authors page for each of the included oncology journals for adherence to common reporting guidelines and trial registration policies. We corresponded with editors to determine accepted study types and cross-referenced this information with a journal’s RGs and trial registration policies to calculate the per cent of journals that adhere to a specific guideline or policy. 76.2% (16/21) of oncology journals surveyed adhere to Consolidated Standards of Reporting Trials guidelines for clinical trials while only 33.3% (7/21) adhere to Strengthening the Reporting of Observational Studies in Epidemiology for observational studies. Similarly, 76.2% (16/21) of oncology journals adhere to clinical trial registration policies. We further demonstrate that journal adherence to RGs positively affects author reporting, despite adherence to trial registration policies showing no such benefit. Our results show that oncology journals adhere to RGs and trial registration policies at a higher rate than other specialties, but nonetheless show room for improvement. We conclude that oncology journal adherence to RGs and trial registration policies is encouraging, but nonetheless suboptimal. We recommend the adoption of RGs and trial registration policies by all oncology journals.

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.

scholarly journals Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bassey Edem ◽  
Chukwuemeka Onwuchekwa ◽  
Oghenebrume Wariri ◽  
Esin Nkereuwem ◽  
Oluwatosin O. Nkereuwem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
Descriptive Analysis ◽  
Sub Saharan Africa ◽  
Trial Registration ◽  
Reporting Bias ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Sub Saharan

Abstract Objective Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020. Methods A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis. Results CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018–2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias. Conclusion Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.

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