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 Visualization analysis of the characteristics of COVID-19 clinical trial

2020 ◽  
Author(s):  
Xiaoqiong Cai ◽  
Zengliang Zheng ◽  
Qianmin Su ◽  
Jihan Huang
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Endpoint ◽  
Trial Registration ◽  
Integrated Medicine ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Intervention Measures ◽  
Laboratory Index ◽  
Design Ideas

Abstract Objectives: This article points out the characteristics and trends of COVID-19 clinical trials through data collection, translation, mining and visualization to help in clinical trial design.Method: The registered data of COVID-19 clinical trials are gathered from the Chinese Clinical Trial Registry and ClinicalTrials.gov website transformed by Python, further demonstrated by visual tools.Results: As of 24:00 on March 28, 2020, totally 732 trial registration records have been retrieved. Overall, there are 406 (55.46%) interventional studies and 271 (37.02%) observational studies. Among interventional studies, 38.93% are randomized parallel trials, 55 (13.55%) trials considered time condition for clinical recovery as the primary endpoint, and 46 (11.33%) trials through clinical parameters and laboratory index as the primary endpoint. In the selection of intervention measures, chemical or biological agents was under the responsibility of 43.60%, of which antivirals accounted for 14.53%, antimalarials accounted for 8.87%, and 98 cases (24.14%) of studies involving Traditional Chinese Medicine or Integrated Medicine. In addition, joint network analysis of antivirals to explore the combination of drugs is further conducted.Conclusions: By Mining characteristic information of topical COVID-19 clinical trial registration, this article deserves further trial design ideas for researchers to enhance the effects.

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.

Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors

2004 ◽  
Vol 141 (6) ◽  
pp. 477 ◽  
Author(s):  
Catherine De Angelis ◽  
Jeffrey M. Drazen ◽  
Frank A. Frizelle ◽  
Charlotte Haug ◽  
John Hoey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Journal ◽  
International Committee ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Journal Editors

Clinical trial registration: a statement from the International Committee of Medical Journal Editors

The Lancet ◽  
2004 ◽  
Vol 364 (9438) ◽  
pp. 911-912 ◽  
Author(s):  
Catherine De Angelis ◽  
Jeffrey M Drazen ◽  
Frank A Frizelle ◽  
Charlotte Haug ◽  
John Hoey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Journal ◽  
International Committee ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Journal Editors

Registration of Rectal Cancer-Related Clinical Trials on Chinese Clinical Trial Registry over past decades

2020 ◽  
Author(s):  
Jun-hong Hu ◽  
Shi-Can Zhou ◽  
Quan Zhang ◽  
Xing- Wang Li ◽  
Chen-Yu Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Hospital Funding ◽  
Local Finance ◽  
Multicenter Clinical Trials ◽  
Data Library

Abstract Background This study investigated and analyzed rectal cancer-related clinical trials registered on Chinese Clinical Trial Registry (Chi-CTR) by the end of 2018. We aimed to discuss the characteristics and developmental trends. Methods The Chi-CTR database was searched and all clinical trials related to rectal cancer extracted. The time limit for the search was from the establishment of the data library to December 31, 2018. The characteristics of registered clinical trials were then analyzed. Results A total of 70 clinical trials were retreived. Beijing, Shandong, and Guangzhou accounted for 47.1% of the total number of registered clinical trials. Sichuan and Sun Yat-sen Universities having the highest number of registrations. The registration status of the 55 trials was prospective registration. The top sources of funding were self-financing (41.4%), hospital funding (22.9%) and local finance (15.7%). Out of the 43 randomized controlled trials, 39 were either blank or missing in the blinded section. The sample size of clinical trials was high in 100 to 199 cases. Only eight of the 70 trials were multicenter clinical trials. Conclusions Relevant departments should increase the registration of clinical trials, increase the awareness of registration, and promote the development of high-quality clinical trials. At the same time, researchers should raise the awareness of clinical trial registration, and actively carry out multi-center clinical trials.

Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development

2016 ◽  
Vol 27 (1) ◽  
pp. 2-9
Author(s):  
Abhishek Biswas ◽  
C V Shendkar ◽  
Bikas K Arya ◽  
PK Lenka ◽  
Ratnesh Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Device ◽  
Point Of Care ◽  
Clinical Trial Design ◽  
Trial Protocol ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration

Abstract Objective This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed. Design and Methods The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI. Conclusions Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.

scholarly journals Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Heba Omar ◽  
Wessam Adel Aboella ◽  
Mohammed Mahmoud Hassan ◽  
Amany Hassan ◽  
Passaint Hassan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Magnesium Sulfate ◽  
Spinal Anaesthesia ◽  
Sedation Score ◽  
Trial Registration ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Hyperbaric Bupivacaine ◽  
Clinical Trial Registration ◽  
Group D

Abstract Background Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. Methods This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 μg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. Results Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. Conclusions Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. Trial registration Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727; January 2018, “retrospectively registered”.

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.

Sign in / Sign up

Export Citation Format

Share Document