scholarly journals Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bronwyn Myers ◽  
Claire van der Westhuizen ◽  
Megan Pool ◽  
Nancy Hornsby ◽  
Katherine R. Sorsdahl
Keyword(s):  
Clinical Trials ◽  
Psychological Intervention ◽  
High Income ◽  
Lessons Learned ◽  
Feasibility Trial ◽  
Pharmacological Intervention ◽  
Middle Income ◽  
Trial Conduct ◽  
The Impact ◽  
Low And Middle Income

Abstract The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited to pharmacological intervention trials from high-income settings. The purpose of this paper is to expand the literature to include a low- and middle-income country perspective. We describe the challenges posed by COVID-19 for a randomised feasibility trial of a psychological intervention for adolescents in Cape Town, South Africa, and lessons learned when implementing strategies to facilitate trial continuation in this context. We used a Plan-Do-Study-Act cycle method to explore whether our adaptations were having the desired effect on trial accrual and retention. We found that stakeholder engagement, trial coordination and team communication need to be intensified while testing these procedural changes. We learned that strategies found to be effective in high-income countries required significant adaptation to our resource-constrained setting. The detailed documentation of extraneous influences, procedural changes and trial process information was essential to guiding decisions about which adaptations to retain. This information will be used to examine the potential impact of these changes on study outcomes. We hope that these reflections will be helpful to other trialists from low- and middle-income countries grappling with how to minimise the impact of public health emergencies on their research. Trial registration The trial is registered with the Pan African Clinical Trials Registry (PACTR20200352214510). Registered 28 February 2020.  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9795.

scholarly journals Capital account opening and economic growth——an empirical test based on systematic GMM

2021 ◽  
Vol 235 ◽  
pp. 01019
Author(s):  
Siming Jia
Keyword(s):  
Economic Growth ◽  
Empirical Test ◽  
Statistical Significance ◽  
High Income ◽  
Capital Account ◽  
Middle Income ◽  
Middle Income Countries ◽  
National Differences ◽  
The Impact ◽  
Low And Middle Income

This paper collected panel data of 74 countries from 1990 to 2017, and based on the Chinn-It index to depict the degree of capital account opening. Under the framework of the neoclassical economic growth model, the impact of capital account opening on economic growth was empirically tested by systematic GMM. The results show that: first, taking the overall capital account openness as the explanatory variable, the coefficient of the capital account openness of the whole sample is significantly positive. Further, considering the national differences found that high income countries capital account openness coefficient is significantly positive, but in low and middle-income countries capital account openness coefficient on economic and statistical significance were not significant, indicating that high income countries made open dividends, while in low and middle-income countries and earnings in the capital account liberalization. Finally, it proposes to open the capital account sub-projects step by step, strengthen prudent supervision in the process of further opening the capital account, and improve the regulatory legal system.

scholarly journals COVID-19, Governance, and Conflict: Emerging Impacts and Future Evidence Needs

2021 ◽  
Author(s):  
Siân Herbert ◽  
Heather Marquette
Keyword(s):  
Social Sciences ◽  
Public Health ◽  
High Income ◽  
Middle Income ◽  
Middle Income Countries ◽  
The Social ◽  
Global Nature ◽  
Bodies Of Evidence ◽  
The Impact ◽  
Low And Middle Income

This paper reviews emerging evidence of the impact of COVID-19 on governance and conflict, using a “governance and conflict first” approach in contrast to other research and synthesis on COVID-19 in the social sciences that tends to be structured through a public health lens. It largely focuses on evidence on low- and middle-income countries but also includes a number of examples from high-income countries, reflecting the global nature of the crisis. It is organised around four cross-cutting themes that have enabled the identification of emerging bodies of evidence and/or analysis: Power and legitimacy; Effectiveness, capacity, and corruption; Violence, unrest, and conflict; and Resilience, vulnerability, and risk. The paper concludes with three over-arching insights that have emerged from the research: (1) the importance of leadership; (2) resilience and what “fixing the cracks” really means; and (3) why better ways are needed to add up all the “noise” when it comes to COVID-19 and evidence.

Cross-country income variations and inclusive financing

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Muhammad Nabeel Safdar ◽  
Tian Lin ◽  
Saba Amin
Keyword(s):  
Information Technology ◽  
Principal Component ◽  
High Income ◽  
Financial Inclusion ◽  
Middle Income ◽  
Content Type ◽  
Middle Income Countries ◽  
Cross Country ◽  
The Impact ◽  
Low And Middle Income

Purpose This study, a symposium, aims to explore the determinants of financial inclusion, impact of cross-country income-variations on financial inclusion, do high-income countries really uplift the financial inclusion and does the higher financial inclusion index indicate the larger economy? Design/methodology/approach This study adopts the panel data model to investigate the impact of high-income countries and low- and middle-income countries on financial inclusion. However, this study further adopts the principal component analysis rather than Sarma’s approach to calculate the financial inclusion index. Findings Based on the Data of World Bank, United Nations, International Monetary Fund, World Development Indicators, this study concludes that there is no nexus between income variations and financial inclusion, as the study reveals that some low- and middle-income countries have greater financial inclusion index such as Thailand (2.8538FII), Brazil (1.9526FII) and Turkey (0.8582FII). In low- and middle-income countries, the gross domestic product per capita, information technology and communication, the rule of law, age dependency ratio and urbanization have a noteworthy impact on financial inclusion that accumulatively describe the 83% of the model. Whereas, in high-income countries, merely, information technology and urbanization have a substantial influence on the growth of financial revolution and financial inclusion that describes the 70% of the total. Research limitations/implications The biggest limitation is the availability of data from different countries. Originality/value The originality of this paper is its technique, which is used in this paper to calculate the financial inclusion index. Furthermore, this study contributes to 40 different countries based on income, which could help to boost financial inclusion, and ultimately, it leads them toward economic growth.

The changing atlas of clinical research in cancer: Measuring accessibility to clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14123-e14123
Author(s):  
Luca Mazzarella ◽  
Giulia Tini ◽  
Pammolli Fabio ◽  
Righetto Lorenzo ◽  
Giuseppe Curigliano ◽  
...  
Keyword(s):  
Resource Allocation ◽  
Clinical Trials ◽  
Clinical Research ◽  
Phase 1 ◽  
Healthcare Research ◽  
Site Location ◽  
Middle Income ◽  
Trial Conduct ◽  
Global Economic Growth ◽  
The Impact

e14123 Background: The recent global economic growth produced dramatic social changes that impacted healthcare. Private industries, low and middle income countries increased their interest in clinical research. How these changes impact on accessibility to clinical trials has not been sufficiently studied, an issue becoming more relevant as trials increasingly constitute a relevant source of access to innovative drugs. Methods: We analyzed changes related to funding source, phase and locations involved in all interventional clinical trials on cancer extracted from clinicaltrials.gov from 2005 to 2019. We studied the evolution of accessibility to clinical trials on worldwide scale, by developing a family of indexes weighted on population, distance from the site location, numbers of trials. These indexes were also used to simulate different resource allocation models. Results: The absolute involvement of industry in clinical trials consistently increased (~6 fold over 2005), with a significant bias for phase 1 trials; however, its relative impact has globally remained the same. The geographical distribution of trial sites changed dramatically: some nations (China, Korea) increased their total number of trials 50 fold. The number of countries with ≥10 multicentric studies grew from 3 to 16. Our accessibility index (Table, relative increment on 2005 in parenthesis) shows that Asia had the highest improvement, with Korea and Taiwan as leading countries. The analysis captures significant trends associated with changing policies on trial conduct, such as the introduction in 2012 and abandonment in 2015 of centralized ethical committees in Brazil, or the introduction of EUdract in Europe in 2015. Simulations allowed to identify specific resource allocations to maximize accessibility. Conclusions: Accessibility to clinical trials is improving worldwide, but with important differences across continents and countries, which follow social, economic and political changes. Our accessibility indexes can inform national and continental healthcare/research policies, as they predict the impact of different resource allocation models, representing useful tools to facilitate access to innovative treatments. [Table: see text]

scholarly journals Challenges of clinical trials in low- and middle-income countries

2012 ◽  
Vol 9 (2) ◽  
pp. 30-31
Author(s):  
Akwasi Osei
Keyword(s):  
Clinical Trials ◽  
Low Income ◽  
High Income ◽  
International Standards ◽  
Low Income Countries ◽  
Profit Motive ◽  
High Quality ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Clinical trials have been conducted almost wholly in high-income countries until recently, yet their results may not always be valid or applicable in middle- and low-income countries. Clinical trials are now, though, increasingly being done in less wealthy countries. While this is welcome, there is a need to ensure the profit motive does not override the benefits. Partnership with local counterparts while adhering to international standards should help to maintain high-quality output from clinical trials.

scholarly journals Timing of Pubertal Milestones in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 11 (4) ◽  
pp. 951-959 ◽  
Author(s):  
Jenna L Moodie ◽  
Susan C Campisi ◽  
Kristen Salena ◽  
Megan Wheatley ◽  
Ashley Vandermorris ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Grey Literature ◽  
Tanner Stage ◽  
High Income ◽  
Age At Menarche ◽  
Middle Income ◽  
Middle Income Countries ◽  
The Impact ◽  
Low And Middle Income

ABSTRACT Despite increasing global attention to adolescent health in low- and middle-income countries (LMICs), limited literature exists on the timing of pubertal development in these settings. This study aimed to determine the age at menarche (AAM) and age of puberty onset [female Tanner Stage Breast 2 (B2) and male Tanner Stage Genital 2 (G2)] among healthy adolescents living in LMICs. It also aimed to explore the impact of nutritional status on pubertal timing in this population. MEDLINE, Embase, Cochrane CENTRAL, Web of Science, Scopus, and grey literature databases were searched. Observational studies and control arms of randomized controlled trials (RCTs) with healthy participants from LMICs born in or after 1998 were included. Pooled estimates with 95% CIs were calculated by random-effects meta-analyses using the DerSimonian and Laird inverse variance method for each pubertal milestone and by BMI category subgroups. Twenty-seven studies were included in the meta-analysis, representing 90,188 adolescents (78.3% female). Pooled mean estimates for AAM for normal, thin, and overweight BMI groupings were 12.3 y (95% CI: 12.1, 12.5), 12.4 y (95% CI: 12.2, 12.6), and 12.1 y (95% CI: 11.7, 12.5), respectively. For Tanner Stage B2, pooled mean age estimates for normal, thin, and overweight BMI groupings were 10.4 y (95% CI: 9.2, 11.6), 10.2 y (95% CI: 9.3, 11.4), and 8.4 y (95% CI: 6.8, 10.0), respectively. Finally, for Tanner Stage G2, pooled mean estimates for normal, thin, and overweight BMI groupings were 11.0 y (95% CI: 10.3, 11.7), 11.3 y (95% CI: 9.8, 12.9), and 10.3 y (95% CI: 10.0, 10.6), respectively. Data on the timing of pubertal milestones has traditionally come from high-income settings. In this systematic review of contemporary data from adolescents in LMICs, AAM, as well as age at pubertal onset, were similar to those reported from high-income settings.

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