Introduction: The purpose of this study was to review the validity of clinical trials and checklists used to evaluate them in systematic reviews and meta-analyses.
Methods: We researched Medline and bibliographies of relevant articles with use of keywords and author names.
Results: Methodological choices that have a demonstrated influence on the results of clinical trials include collecting informed consent, comparison of publication with protocol, selection of patients, randomization procedure, number of subjects to include, number lost to follow-up, blinding of patients and evaluation. The type of comparison (with placebo and classic treatment, adjustment of level of significance to the number of measures and number of criteria) and intent-to-treat analysis has a demonstrated influence. The level of this influence is not always precisely determined. In some other fields we didn't find any scientific demonstration even if they have a potential effect.
Conclusion: The validity of quantitative checklists is low because of lack of scientific demonstration of their relevance.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.annrmp.2005.02.004 | DOI Listing |
Viruses
December 2024
Pharmalex India Pvt. Ltd., Noida 201301, India.
Nasal spray treatments that inhibit the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) entry into nose and nasopharynx at early stages can be an appropriate approach to stop or delay the progression of the disease. We performed a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentric, phase II clinical trial comparing the rate of hospitalization due to COVID-19 infection between azelastine 0.1% nasal spray and placebo nasal spray treatment groups.
View Article and Find Full Text PDFViruses
November 2024
Laboratório de Imunofarmacologia, Instituto Oswaldo Cruz (IOC), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro 21040-361, RJ, Brazil.
Coronavirus disease 2019 (COVID-19) still causes death in elderly and immunocompromised individuals, for whom the sustainability of the vaccine response may be limited. Antiviral treatments, such as remdesivir or molnupiravir, have demonstrated limited clinical efficacy. Nirmatrelvir, an acute respiratory syndrome coronavirus 2 (SARS-CoV-2) major protease inhibitor, is clinically effective but has been associated with viral rebound and antiviral resistance.
View Article and Find Full Text PDFViruses
November 2024
Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003 Lisbon, Portugal.
This systematic review assessed the prevalence of transmitted and acquired HIV drug resistance (HIVDR) and the associated risk factors in Mozambique. A search of the PubMed, Cochrane, B-On, and Scopus databases up to December 2023 was conducted and included 11 studies with 1118 HIV-1 pol sequences. Drug resistance mutations (DRMs) to NNRTIs were found in 13% of the drug-naive individuals and 31% of those on ART, while NRTI resistance occurred in 5% and 10%, respectively.
View Article and Find Full Text PDFVaccines (Basel)
December 2024
School of Healthcare, University of Leicester, Leicester LE1 7RH, UK.
Vaccinating care home staff is essential to protect vulnerable residents by reducing infection risks and creating a safer care environment. However, vaccine hesitancy amongst staff remains a challenge, particularly since the COVID-19 pandemic raised concerns about side effects and vaccination mandates. This study examines how the pandemic influenced flu vaccine hesitancy amongst UK care home staff.
View Article and Find Full Text PDFVaccines (Basel)
December 2024
Center for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!