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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10496585 | PMC |
| http://dx.doi.org/10.1590/1516-3180.2014.00441803 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Allogeneic DNT cell therapy synergizes with T cells to promote anti-leukemic activities while suppressing GvHD.
J Exp Clin Cancer Res
January 2025
Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a second-line treatment with curative potential for leukemia patients. However, the prognosis of allo-HSCT patients with disease relapse or graft-versus-host disease (GvHD) is poor. CD4 or CD8 conventional T (Tconv) cells are critically involved in mediating anti-leukemic immune responses to prevent relapse and detrimental GvHD.
View Article and Find Full Text PDFAlzheimer's disease: an integrative bioinformatics and machine learning analysis reveals glutamine metabolism-associated gene biomarkers.
BMC Pharmacol Toxicol
January 2025
Yantai Affiliated Hospital of Binzhou Medical University, Yantai, Shandong, 264100, PR China.
Background: Alzheimer's disease (AD), a hallmark of age-related cognitive decline, is defined by its unique neuropathology. Metabolic dysregulation, particularly involving glutamine (Gln) metabolism, has emerged as a critical but underexplored aspect of AD pathophysiology, representing a significant gap in our current understanding of the disease.
Methods: To investigate the involvement of GlnMgs in AD, we conducted a comprehensive bioinformatic analysis.
Effect of early administration of fibrinogen replacement therapy in traumatic haemorrhage: a systematic review and meta-analysis of randomised controlled trials with narrative synthesis of observational studies.
Crit Care
January 2025
Centre for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, England.
Background: In severely injured trauma patients, hypofibrinoginaemia is associated with increased mortality. There is no evidence-based consensus for what constitutes optimal fibrinogen therapy, treatment dose or timing of administration. The aim of this systematic review was to evaluate the effects of early fibrinogen replacement, either cryoprecipitate or fibrinogen concentrate (FgC) on mortality, transfusion requirements and deep venous thrombosis (DVT).
View Article and Find Full Text PDFEffects of intra-class peer mentorship intervention programme on the academic performances of academically underperforming medical students in Nigeria.
BMC Med Educ
January 2025
Department of Human Physiology, Nnamdi Azikiwe University, Awka, Nigeria.
Background: A significant gap exists in understanding the effectiveness of intra-class (same-class) level peer mentorship programmes designed to enhance academic performance, well-being, and student involvement among underperforming medical students. This study assessed the effectiveness of intra-class (same-class) peer mentorship programme on the academic performances, subjective well-being and school engagement of academically underperforming medical students in Nigeria.
Methods: This was a quasi-experimental research consisting of the pretest-posttest control design at Nnamdi Azikiwe University, Awka, Nigeria.
Self-administered active versus sham acupressure for diarrhea predominant irritable bowel syndrome: a nurse-led randomized clinical trial.
BMC Nurs
January 2025
Medical Surgical Nursing Department, Faculty of Nursing, Alexandria University, Alexandria, Egypt.
Background: Diarrhea-predominant irritable bowel syndrome (IBS-D) significantly impacts patients' quality of life, with existing treatments offering limited relief. Self-administered acupressure presents a potential non-invasive, cost-effective treatment option that could alleviate symptoms and enhance health outcomes in these patients.
Aim: This randomized controlled trial aimed to evaluate the effect of active acupressure compared to sham acupressure on primary and secondary outcomes among IBS-D patients.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!