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Background: Migrants and refugees/asylum seekers, as a large part of the European work force, are often confronted with unfavorable working conditions in the host country. Main aim of this systematic review was to compare the association of these working conditions with mental health between migrants and refugees/asylum seekers due to their diverse migration experiences and cultural origins, and between different European host countries., Methods: Systematic search for eligible primary studies was conducted in three electronic databases (PubMed/MEDLINE, PsycINFO and CINAHL) using quantitative study designs written in English, German, French, Italian, Polish, Spanish or Turkish and published from January 1, 2016 to October 27, 2022. Primary health outcomes were diagnosed psychiatric and psychological disorders, suicide and suicide attempts, psychiatric and psychological symptoms, and perceived distress. Secondary health outcomes were more general concepts of mental health such as well-being, life satisfaction and quality of life. Two reviewers independently completed screening, data extraction and the methodological quality assessment of primary studies using the Newcastle-Ottawa-Scale. Descriptive summary of primary studies on working conditions and their relationship with mental health were conducted, comparing migrants and refugees/asylum seekers, migrants and refugees/asylum seekers of different cultural backgrounds (collectivistic and individualistic) and migrants and refugees/asylum seekers living in different host countries., Results: Inclusion criteria were met by 19 primary studies. Voluntary migrants are more likely to experience overqualification in the host country than refugees. In all examined host countries, migrants and refugees suffer from unfavorable working conditions, with migrants from collectivistic countries being slightly at risk compared to migrants from individualistic countries. Most unfavorable working conditions are related to poor mental health, regardless of migrant status, cultural origin or host country., Conclusions: Although the results should be interpreted with caution due to the small number of studies, it is evident that to maintain both the mental health and labor force of migrants and refugees/asylum seekers, their working conditions in host countries should be controlled and improved. Special attention should be paid to specific subgroups such as migrants from collectivistic societies., Ethics and Dissemination: This systematic review is excluded from ethical approval because it used previously approved published data from primary studies., Trial Registration Number: CRD42021244840., (© 2024. The Author(s).)

Objective: Migrants and refugees/asylum seekers make up a significant proportion of the European workforce. They often suffer from poor working conditions, which might impact mental health. The main objective of this systematic review was to summarize and analyze existing research on working conditions of migrants and refugees/asylum seekers in European host countries and compare them to those of natives. Furthermore, the relationship between working conditions and mental health of migrants/refugees/asylum seekers and natives will be compared., Methods: Three electronic databases (PubMed/MEDLINE, PsycInfo and CINAHL) were systematically searched for eligible articles using quantitative study designs written in English, German, French, Italian, Polish, Spanish or Turkish and published from January 1, 2016 to October 27, 2022. Primary health outcomes were diagnosed psychiatric and psychological disorders, suicide (attempts), psychiatric and psychological symptoms, and perceived distress. Secondary health outcomes were more general concepts of mental health such as well-being, life satisfaction and quality of life. Screening, data extraction and the methodological quality assessment of primary studies by using the Newcastle-Ottawa Scale were done independently by two reviewers. The results of the primary studies were summarized descriptively. Migrants and refugees/asylum seekers were compared with natives in terms of the association between working conditions and mental health., Results: Migrants and refugees often face disadvantages at work concerning organizational (low-skilled work, overqualification, fixed-term contracts, shift work, lower reward levels) and social conditions (discrimination experiences) in contrast to natives. Most unfavorable working conditions are associated with worse mental health for migrants as well as for natives., Conclusions: Even if the results are to be taken with caution, it is necessary to control and improve the working conditions of migrants and refugees/asylum seekers and adapt them to those of the native population to maintain their mental health and thus their labor force., (© 2023. The Author(s).)

The coronavirus disease 2019 (COVID-19) pandemic has a major impact not only on public health and daily living, but also on clinical trials worldwide. To investigate the potential impact of the COVID-19 pandemic on the initiation of clinical trials, we have descriptively analyzed the longitudinal change in phase II and III interventional clinical trials initiated in Europe and in the United States. Based on the public clinical trial register EU Clinical Trials Register and clinicaltrials.gov, we conducted (i) a yearly comparison of the number of initiated trials from 2010 to 2020 and (ii) a monthly comparison from January 2020 to February 2021 of the number of initiated trials. The analyses indicate that the COVID-19 pandemic affected both the initiation of clinical trials overall and the initiation of non-COVID-19 trials. An increase in the overall numbers of clinical trials could be observed both in Europe and the United States in 2020 as compared with 2019. However, the number of non-COVID-19 trials initiated is reduced as compared with the previous decade, with a slightly larger relative decrease in the United States as compared to Europe. Additionally, the monthly trend for the initiation of non-COVID-19 trials differs between regions. In the United States, after a sharp decrease in April 2020, trial numbers reached the levels of 2019 from June 2020 onward. In Europe, the decrease was less pronounced, but trial numbers mainly remained below the 2019 average until February 2021., (© 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Introduction Migrants make up a significant proportion of the European working population. Previous studies have already shown that migrants and refugees often suffer from poor work-related conditions in the host country, which might have an impact on mental health. Thus, the main objective of this systematic review is to analyse and summarise existing research on work-related conditions of migrants and refugees in Europe and to investigate the relationship of these conditions with their mental health., Methods and Analysis: Three electronic databases (PubMed/MEDLINE, PsycINFO and CINAHL) will be systematically searched for eligible articles using quantitative study designs (randomised controlled trials, cohort, case-control and cross-sectional studies with and without control groups) written in English, German, French, Italian, Polish, Spanish or Turkish and published from 1st January 2016 onwards. The primary health outcomes will be diagnosed psychiatric and psychological disorders, suicide and suicide attempts, psychiatric and psychological symptoms, and perceived distress. The secondary health outcomes will be more general concepts of mental health such as well-being, life satisfaction and quality of life. Outcome measures must have been assessed by validated questionnaires. Screening of all articles, reference lists of included studies and relevant reviews as well as data extraction will be performed independently by two review authors. Methodological quality of primary studies will be assessed and discussed. The results of the primary studies will be summarised descriptively. Migrants and natives, migrants and refugees, migrants of different cultural backgrounds and migrants living in different host countries will be compared in terms of the association between their work-related conditions and their mental health., Ethics and Dissemination: This systematic review is excluded from ethical approval because it will use previously approved published data from primary studies. The results of this review will be submitted to a related peer-reviewed journal., Prospero Registration Number: CRD42021244840., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Timely and successful drug development for rare cancer populations, such as pediatric oncology, requires consolidated efforts in the spirit of shared responsibility. In order to advance tailored development efforts, the concept of multistakeholder Strategy Forum involving industry, academia, patient organizations, and regulators has been developed. In this study, we review the first five pediatric oncology Strategy Forums co-organized by the European Medicines Agency between 2017 and 2020, reflecting on the outcomes and the evolution of the concept over time and providing an outline of how a "safe space" for multistakeholder engagement facilitated by regulators could be of potential value beyond pediatric oncology drug development., (© 2020 The Authors Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.)

On March 28, 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the marketing authorization for the medicinal product plerixafor. The marketing authorization holder for this medicinal product is Genzyme Europe B.Th. The adoption was for an extension of the existing adult indication in combination with granulocyte colony-stimulating factor (G-CSF) to pediatric patients (aged 1 year to <18 years) to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumors. This treatment is indicated either preemptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regard to desired hematopoietic stem cells yield, or in children who previously failed to collect sufficient hematopoietic stem cells. The efficacy and safety of plerixafor were evaluated in an open label, multicenter, phase I/II, dose-ranging, and randomized controlled study (DFI12860) in pediatric patients with solid tumors, including neuroblastoma, sarcoma, Ewing sarcoma, or lymphoma, who were eligible for autologous hematopoietic stem cell transplantation. Forty-five patients (aged 1 year to <18 years) were randomized, 2:1, using 0.24 mg/kg of plerixafor plus standard mobilization (G-CSF with or without chemotherapy) versus control (standard mobilization alone). The primary analysis showed that 80% of patients in the plerixafor arm experienced at least a doubling of the peripheral blood (PB) CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus 28.6% of patients in the control arm (p = .0019). The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm. The observed safety profile in the pediatric population was consistent with that in adults, with adverse events mainly related to injection site reactions, hypokalemia, and increased blood bicarbonate. Importantly, plerixafor exposure did not seem to negatively affect transplant efficiency. This article summarizes the scientific review of the application leading to regulatory approval in the European Union. IMPLICATIONS FOR PRACTICE: This review of the marketing authorization of plerixafor will raise awareness of pediatric indication granted for this medicinal product., (© AlphaMed Press 2020.)