The impact of social cohesion and risk communication on excess mortality due to COVID-19 in 213 countries: a retrospective analysis.

Background: Tools for assessing a country's capacity in the face of public health emergencies must be reviewed, as they were not predictive of the COVID-19 pandemic. Social cohesion and risk communication, which are related to trust in government and trust in others, may have influenced adherence to government measures and mortality rates due to COVID-19.

Objective: To analyse the association between indicators of social cohesion and risk communication and COVID-19 outcomes in 213 countries.

All-fiber broadband spectral acousto-optic modulation of a tubular-lattice hollow-core optical fiber.

We demonstrate a broadband acousto-optic notch filter based on a tubular-lattice hollow-core fiber for the first time to our knowledge. The guided optical modes are modulated by acoustically induced dynamic long-period gratings along the fiber. The device is fabricated employing a short interaction length (7.

National governance and excess mortality due to COVID-19 in 213 countries: a retrospective analysis and perspectives on future pandemics.

Background: National governance may have influenced the response of institutions to the Covid-19 pandemic, being a key factor in preparing for the next pandemics. The objective was to analyze the association between excess mortality due to COVID-19 (daily and cumulative per 100 thousand people) and national governance indicators in 213 countries.

Method: Multiple linear regression models using secondary data from large international datasets that are in the public domain were performed.

Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.

Background Aims: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on gene, tissues or cells. ATMPs have peculiar characteristics when compared with traditional medicines. In this regard, long-term safety and efficacy follow-up systems of individuals treated with ATMPs have become necessary and may present unique challenges, because unlike conventional drugs and biologics, these products can exert their effects for years after administration.

The High "Cost" of Experimental Drugs Obtained Through Health Litigation in Brazil.

Background: Brazilian patients have legal right to access unlicensed medicines undergoing clinical research, if there is evidence of efficacy and safety. This study investigated the occurrence of serious adverse events related to very high-cost medicines from clinical studies, expanded access and compassionate use programs, obtained by patients though health litigation.

Methods: A descriptive study using secondary data investigated unlicensed medicines obtained through lawsuits from 2010 to 2017, costing more than 1 million Brazilian reais (BRL), adjusted by the Brazilian Consumer Index to July 2017.

Research Priorities and Resource Allocation in the Investigation of New Drugs for Cancer in Least Developed Countries.

Cancer incidence has increased significantly in low- and middle-income countries. The priorities of international health research are not always aligned with the global burden of cancer. This study aims to analyze global tendencies in clinical trials in oncology and discuss research priorities and resource allocation in the investigation of new drugs for cancers that significantly affect the least developed countries.

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Purpose: Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development.

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

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.

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

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. 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. 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).