International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs

Introduction: Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs.Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials.Methods: The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP).Results: Non-communicable diseases such as diabetes, cancer, and asthma—studies which were financed mainly by industries—were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue.Conclusion: The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials

Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured.Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region.Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities.Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children.Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because vulnerability is not applicable to all risk situations

GQ-16 treatment reduces diet-induced weight gain and visceral adipose tissue mass despite increasing energy intake.

<p>(<b>A</b>) Body weight gain, (<b>B</b>) epididymal (epiWAT) fat pad mass, (<b>C</b>) inguinal (ingWAT) fat pad mass, (<b>D</b>) energy intake, (<b>E</b>) metabolic efficiency and (<b>F</b>) daily water intake after treatment with vehicle, rosiglitazone (RSG, 4 mg/kg/d), or QG-16 (40 m/kg/d) for two weeks. Visceral adiposity was expressed as the ratio of visceral fat weight to body weight. Subcutaneous adiposity was expressed as the ratio of subcutaneous fat weight to body weight. Data are presented as mean ± SEM. Statistical analysis was done using ANOVA followed by Newman-Keuls post hoc test. * <i>p</i> < 0.05 <i>vs</i> control diet group that received vehicle, # <i>p</i> < 0.05 <i>vs</i> HFD group that received vehicle, + <i>p</i> < 0.05 <i>vs</i> HFD that received rosiglitazone, & <i>p</i> < 0.05 <i>vs</i> all other groups. n = 4 animals per group.</p

GQ-16 treatment increases UCP-1 expression in interscapular brown adipose tissue.

<p>UCP-1 immunostaining in sections of interscapular brown adipose tissue (iBAT) obtained from mice after treatment with vehicle, rosiglitazone (RSG, 4 mg/kg/d), or QG-16 (40 mg/kg/d) for two weeks. Representative Images (three total images per group) are shown at 20x magnification, scale bar, 50 μm. Slides were stained with NovaRED substrate that produces a red-stain in UCP-1 protein and they were counterstained with hematoxylin that results in blue-violet staining of nuclei.</p