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Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a 'rescue option' when submitted data are not strong enough to justify full marketing authorization. [ABSTRACT FROM AUTHOR]

The present study aims to test the impact of a self-leadership intervention on the work engagement, performance, and health of health care workers. By integrating self-determination theory and self-leadership theory, we propose that when employees are trained how they can autonomously influence own cognitions and behaviour, this will impact their work engagement, perceived performance, and general health. To test the hypotheses, a longitudinal field experiment with three measurement waves was conducted (pre-intervention, immediately after the intervention, and 2 months after the intervention). Health care professionals ( n  = 195) from five different organizations participated on voluntary basis and were randomly assigned to the intervention or control group. Results show that a self-leadership training positively impacts work engagement and performance of health care workers. Furthermore, the improved work engagement also mediates the effects of the training on health and performance 2 months later. No direct effect was found on general health. Theoretical and practical implications are discussed., Practitioners Points: The self-leadership intervention facilitates healthcare workers to develop self-determination and autonomous motivation, which will positively impact their work engagement, health, and performanceParticipation in the self-leadership intervention needs to be based on volition as this will contribute to the intrinsic motivation for actual self-leadership development through training., Competing Interests: All authors declare no conflict of interest., (© 2021 The Authors. Journal of Occupational and Organizational Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.)

Objective: We examined the prevalence of mental health problems in refugees living in camps that emerged in Tanzania during the Rwanda crisis that started in 1994., Method: Using the 28-item version of the General Health Questionnaire (GHQ-28), we examined two samples: a random sample (n = 854) and a sample of clients of a psychosocial support programme in these camps (n = 23). Sensitivity, specificity and positive- and negative predictive values were estimated for several cut-off scores of the GHQ-28., Results: The prevalence of serious mental health problems was estimated at 50% (SE 12%). When using the GHQ-28 as a screener, a cut-off score of 14 is recommended., Conclusion: Given the high prevalence of mental health problems, psychosocial programmes for large refugee populations should aim at strengthening community structures and supporting groups instead of focusing at individuals. The screening capacity of the GHQ-28 could be used to identify mentally vulnerable groups.

We studied the short- and long-term effects of a fractionated injection of cis-diamminedichloroplatinum (II) (CDDP) upon the haemopoietic stroma and the haemopoietic precursor cell compartment of young and adult mice. The integrity of the stromal microenvironment was investigated using three different assays including quantification of (a) the fibroblastoid progenitor cell compartment, (b) the regenerative capacity after subcutaneous implantation of spleen and femur, and (c) the growth of normal bone marrow progenitors in lethally irradiated CDDP-treated mice. CDDP treatment induced a slight anaemia which lasted for the observation period of 1 year, and could not be restored by infusion of normal bone marrow cells. The population size of haemopoietic progenitors was severely decreased immediately after CDDP treatment and the CFU-S recovery in the bone marrow was slow and temporary. Stromal function was significantly decreased and normalization occurred within approximately 40 d, depending on the stromal parameter measured. Subsequently, the regenerative capacity of the stroma showed a second decrease which was still detected at 1 year. This pattern of stromal damage has not been reported for any other cystostatic agent. Since the other two assays did not detect a second decrement in stromal integrity it is implied that the three stromal assays used detect different stromal functions. We conclude that CDDP treatment of both young and adult mice results in severe short-term damage and a late occurring secondary regenerative defect of the haemopoietic organ stroma.