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Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum
(Oxford University Press, 2023)
Participants enrolled in cardiovascular disease (CVD) randomized controlled trials are not often representative of the population living with the disease. Older adults, children, women, Black, Indigenous and People of ...
Botanical drug clinical trial: common issues and future options
Botanical drugs are plant-derived, complex mixtures which may have synergistic effects.
In order to understand this disparity between human use and drugs approved by regulatory agencies,
we analyzed botanical drug clinical ...
Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design
(BioMed Central, 2013)
Background: Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials ...
Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials
(BioMed Central, 2021)
Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective ...
Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20.850 (Ley Ricarte Soto) y su proyecto de reglamento “De los ensayos clínicos de productos farmacéuticos y elementos de uso médico”.
(Sociedad Chilena de Infectología, 2017)
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will ...
Tocilizumab in COVID-19: Enthusiasm vs. evidence
(Wolters Kluwer Health, 2021)
Based on the pathophysiological characterization of COVID-19, initial studies suggested the use of tocilizumab (TCZ), a recombinant humanized monoclonal antibody of the immunoglobulin G1 class, for management of the cytokine ...
Triclabendazole for the treatment of human fascioliasis and the threat of treatment failures
(Taylor and Francis, 2021)
Introduction: The only drug effective against the infection caused by Fasciola hepatica or F. gigantica is triclabendazole (TCBZ), recommended by the WHO and recently approved by the FDA. Here, we describe the evolution ...
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation
(Public Library of Science, 2018)
Introduction: Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated ...
Recent advances in the treatment and prophylaxis of cholera
(Wolters Kluwer Health, 1996)
The utility of antimicrobials in the treatment of cholera is clearly recognized and widely accepted. In recent years the selection of an effective antimicrobial therapy for cholera has been complicated by the appearance ...