[Challenges of international collaborative clinical trials in Asia].

Clinical trials with a solid strategy are indispensable for improving outcomes of rare childhood leukemias such as infant acute lymphoblastic leukemia (ALL) and ALL associated with Down syndrome, and international collaboration contributes to trial success. I am part of a group conducting an international trial of ALL associated with Down syndrome in collaboration with Asian countries. Although we are meeting enrollment targets, there have been no enrollments outside Japan. We also planned a clinical trial in unclassifiable acute leukemia, but abandoned this effort due to a lack of consensus on the choice of treatment regimen. Many elements must fit together for an international trial to succeed, including not only the study's concept, theme, and objectives, but also the organization, the logistics, and, ultimately, trained professionals to carry it out. At the same time, of course, there is the need for appropriate timing and luck. International trials across countries with different cultures, social organizations, and medical systems require persistent effort and negotiation skills. Professional training and infrastructure development are necessary to make this possible.

How to help countries improve resilience during a pandemic: an example of a Rapid Exchange Forum.

BACKGROUND: The COVID-19 pandemic demanded quick exchanges between experts and institutions supporting governments to provide evidence-based information in response to the crisis. Initially, there was no regular cross-country forum in the field of population health. This paper describes the set-up and benefits of implementing such a forum. METHODS: A group of public health practitioners from academia, national public health institutes and ministries of health decided in April 2020 to meet bi-monthly to discuss a vast array of population health topics in a structured format called a Rapid Exchange Forum (REF). An ad-hoc mailing group was established to collect responses to questions brought forward in the forum from at least five countries within 24 h. This endeavour, which evolved as network of networks was awarded an EU grant in autumn 2020 and was called PHIRI (Population Health Information Research Infrastructure). RESULTS: Responses from up to 31 countries were compiled and shared immediately via the European Health Information Portal. This exchange was complemented by special REFs that focused on the advantages and disadvantages of vaccination, for example. By July 2023, 54 REFs had taken place with topics going beyond COVID-19. CONCLUSION: The REF demonstrated its value for quick yet evidence-based cross-country exchange in times of crisis and was highly appreciated by countries and European Commission. It demonstrated its sustainability even after the acute crisis by expanding the topics covered and managing to continue exchange with the aim of capacity building and mutual learning, making it a true EU response and coordination mechanism.

Currency risk analysis of belt and road initiative countries.

The UN's Sustainable Development Goals (SDGs) highlight the role of debt sustainability in achieving sustainable development. China's Belt and Road Initiative (BRI) is an international cooperation effort that is endorsed by over 150 countries and organizations. Given the alignment between BRI development goals and the SDGs, the issue of debt sustainability in BRI countries warrants attention. While existing studies focus on sovereign risk in debt sustainability, there is a lack of emphasis on currency risk, indicating a need for further investigation to mitigate risks and comprehensively evaluate debt stability. Using data from 142 countries, this study examines currency risk reduction in BRI countries by assessing currency competitiveness. We find that the US dollar (USD) is the most competitive currency among BRI countries, followed by the Euro (EUR), Chinese yuan (CNY), sterling pound (GBP), and Japanese yen (JPY). The USD maintains its competitive edge over time, making it the preferred choice, with the EUR as a less optimal option and the CNY showing potential. Geographically, the EUR's close ties with BRI countries lend it prominence, followed by the USD, with the CNY gaining traction. GBP and JPY are considered conservative choices. Recommendations for currency selection vary based on countries' competitiveness, bilateral relationships, and development status.

Trade in torture tools threatens detainees and protestors everywhere - it must be banned.

With social upheaval, economic strain, and political unrest growing, peaceful demonstrations worldwide are increasingly met with brutal tactics by law enforcement and security forces. The UN Special Rapporteur on Torture outlines her call for States to negotiate a new international treaty to ban the manufacture, use and trade in "torture tools" and regulate the trade in law enforcement equipment. Her proposal outlines two critical components: a prohibited list of items that she has deemed to be inherently cruel, inhuman or degrading, and a second controlled list of ordinary law enforcement equipment that has a high risk of misuse. Effective international regulation is imper-ative to curb the indiscriminate use of force by law enforcement and to uphold human dignity. Improved national regulation is also required. Research has revealed a pervasive market for these items, with more than 335 companies in 54 countries manufacturing or promoting the most egre-gious torture instruments. Major producers include China, the EU, and the USA, with emerging economies also contributing significantly. The outsourcing of public functions to private security companies further exacerbates the issue, underscoring the pressing need for robust national and international regulations.

Reinforcing the Unsettled Problem of Biological Weapon Convention in Pakistan: Reasons of Concern and Action.

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Joint WHO/EDQM Collaborative study for the establishment of WHO 3rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7.

An international collaborative study was jointly organised by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO 3rd International Standard (IS) for Prekallikrein activator (PKA) and European Pharmacopoeia (Ph. Eur.) PKA in albumin Biological Reference Preparation (BRP) batch 7. Twenty-six laboratories took part in the study to calibrate these replacement batches, as well as an additional reserve batch for the WHO IS, against the current WHO 2nd IS for PKA (02/168). Ph. Eur. PKA in albumin BRP batch 6 was also included to evaluate the continuity of the consecutive batches of BRP. The centrally calculated overall Huber's means based on the results from laboratories with at least two valid assays were 29.6 and 29.6 IU/ampoule for the candidate WHO 3rd IS (Sample A) and reserve batch (Sample B), and were 38.4 and 37.0 IU/vial for the current BRP batch 6 (Sample C) and the candidate BRP batch 7 (Sample D). The intra-laboratory variation expressed as coefficient of variation (CV) ranged between 1.4 and 16.6 %. The inter-laboratory variation expressed as CV based on Huber's means ranged between 4.4 and 5.4 %. The Huber's mean activity of Sample D against Sample C was 36.6 IU/vial with a CV of 1.7 %. These results confirm the good continuity of the consecutive batches of BRP. Based on the results of this study, it is recommended to establish Sample A as the WHO 3rd IS for PKA with an assigned potency of 30 IU/ampoule and Sample D as the Ph. Eur. PKA in albumin BRP batch 7 with an assigned potency of 37 IU/vial. Sample B is intended to be kept as a future reserve replacement WHO IS.

The "Investigating and translating genomic evidence for public health response to SARS-CoV-2 (INSIDE SARS-CoV-2)" project - Network of excellence. Commentary.

The "Investigating and translating genomic evidence for public health response to SARS-CoV-2 (INSIDE SARS-CoV-2)" project is part of the initiative "Joint science and technology cooperation call for joint project proposals for the years 2021-2023" promoted by the Italian Ministry of Foreign Affairs and International Cooperation (MAECI) and the Republic of India. To start the project activities, the pandemic response and the epidemiological situation in Italy and in India, together with the genomic surveillance strategies for SARS-CoV-2 virus in the two countries, are here described.

Estrategia de Cooperación Técnica con el País: Ecuador 2024-2028

La Organización se complace en suscribir con el Gobierno de Ecuador la Estrategia de Cooperación con el País (ECP) para el período 2024-2028. En virtud de su mandato, condición jurídica independiente y en coordinación con el Sistema de las Naciones Unidas, la OPS colabora con los gobiernos nacionales sobre la base de planes de trabajo bienales (PTBs) y presupuestos elaborados y acordados conjuntamente, los cuales son los principales instrumentos de rendición de cuentas entre la OPS y sus Estados Miembros y la base de los esfuerzos de movilización de recursos financieros y humanos de la OPS. La presente es una apuesta estratégica a mediano plazo para articular las acciones del plan de trabajo de la Organización con las iniciativas y políticas en salud adelantadas por el Estado ecuatoriano, así como las del nivel regional y mundial en apoyo al cumplimiento de los compromisos de la agenda sanitaria internacional.

Factors influencing IMF assistance in the Sub-Saharan African region.

This study examines the determinants influencing the likelihood of Sub-Saharan African (SSA) countries seeking assistance from the International Monetary Fund (IMF). The IMF, as a global institution, aims to promote sustainable growth and prosperity among its member countries by supporting economic strategies that foster financial stability and collaboration in monetary affairs. Utilising panel-probit regression, this study analyses data from thirty-nine SSA countries spanning from 2000 to 2022, focusing on twelve factors: Current Account Balance (CAB), inflation, corruption, General Government Net Lending and Borrowing (GGNLB), General Government Gross Debt (GGGD), Gross Domestic Product Growth (GDPG), United Nations Security Council (UNSC) involvement, regime types (Closed Autocracy, Electoral Democracy, Electoral Autocracy, Liberal Democracy) and China Loan. The results indicate that corruption and GDP growth rate have the most significant influence on the likelihood of SSA countries seeking IMF assistance. Conversely, factors such as CAB, UNSC involvement, LD and inflation show inconsequential effects. Notable, countries like Sudan, Burundi, and Guinea consistently rank high in seeking IMF assistance over various time frames within the observed period. Sudan emerges with a probability of more than 44% in seeking IMF assistance, holding the highest ranking. Study emphasises the importance of understanding SSA region rankings and the variability of variables for policymakers, investors, and international organisations to effectively address economic challenges and provide financial assistance.

Health policy and regulatory authorities: challenges of technology regulation in Public Health Emergencies. / Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública.

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.

As Emergências em Saúde Pública (ESP) têm repercutido nos sistemas de saúde em escala global. O acesso às novas tecnologias em saúde em tempo oportuno é um desafio para a política de saúde. As autoridades reguladoras nacionais (ARN) têm papel fundamental na avaliação e regulação dessas tecnologias. O estudo objetiva analisar as principais estratégias e instrumentos regulatórios utilizados para lidar com os desafios da regulação de novas tecnologias necessárias à resposta do sistema de saúde durante as ESP. Trata-se de uma pesquisa normativa e documental, tendo como fonte a OMS e a ARN brasileira. Foram consideradas as dimensões relacionadas às estratégias para o fortalecimento das atividades regulatórias e os instrumentos regulatórios utilizados para acelerar o acesso às tecnologias, especialmente durante as ESP. A cooperação e a colaboração internacional entre as ARN e com a OMS foram importantes estratégias para o fortalecimento das ARN, com destaque para o uso de confiança, regionalização, avaliações aceleradas e compartilhamento de trabalho/informações, bem como os processos de harmonização e convergência regulatória. Identificou-se, além da utilização de instrumentos regulatórios já existentes, esforços na implementação de novos, com destaque para Autorização de Uso Emergencial.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

Presentation of the first international research network to foster high-quality clinical trials testing non-pharmacological interventions (TRACTION network).

Clinical trials are essential for evaluating the efficacy and safety of new treatments and health interventions. However, while pharmacological trials are well-established, non-pharmacological trials face unique challenges related to their complexity and difficulties such as recruitment, retention, intervention standardisation, selection of outcome measures and blinding of clinicians, participants and data collectors. This communication paper describes the objectives, implementation steps and bylaws of the 'Trials foR heAlth Care inTerventIONs' Network (TRACTION), established by an international multiprofessional task force of experts to foster high-quality non-pharmacological research, ultimately improving patient care and healthcare outcomes.The TRACTION research network will provide information and resources through a collaborative hub for researchers, health professionals, patient research partners and stakeholders in diverse biomedical and healthcare areas, connecting people with different levels of expertise but with the same interests (eg, to evaluate the effect of non-pharmacological interventions, recruiting participants). This open network will support researchers in optimising trial design, participant recruitment, data management and analysis, and disseminating and implementing trial results.The network will also facilitate specialisation training and provide educational materials and mentoring.