Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals.

BACKGROUND: The need to define core competencies for clinical research professionals has been widely recognized. And after the Joint Task Force have proposed Core Competency Framework in 2014 (Sonstein et al. in JAMA 28(3):17-23, 2014), it has been tested and implemented by a variety of researchers and practitioners worldwide, while Ukraine avoided implementing this until recently. METHODS: We surveyed Ukrainian-based clinical research practitioners on their self-assessment in the competency domains proposed by Sonstein et al. (JAMA 28(3):17-23, 2014), tested their GCP knowledge, assessed their level and means of education, and the need to broaden the range of educational tools to reach the standards suggested by the Core Competency Framework. RESULTS: We identified competence issues in four competence domains: Medicines Development and Regulation, Data Management and Informatics, Scientific Concepts and Research Design, and Study and Site Management. Our study also determined that short-term GCP trainings, attended by most of Ukrainian-based clinical research professionals, are insufficient to provide thorough competence in all domains. CONCLUSIONS: The identified knowledge gaps provide evidence for the need to broaden the range of educational tools for Ukrainian-based clinical research professionals; we suggest launching long-term academic program with its curriculum based on the Core Competence Framework.

[The follow-up study of childhood-onset schizophrenia: clinical and social aspects].

Fifty-eight patients, 13 girls and 45 boys, with early-onset schizophrenia (mean 5.4 years) were followed up for 9.5 years. The men age at end point was 19.7 years. Full remission or recovery was not identified in any of the patients. The partial remission was observed in 14 (24%) patients and 44 (76%) patients had chronic course without remissions. Two thirds of patients were disabled including 9 patients with severe, 25 patients with moderate and 1 patient with mild disability. Most of the patients (62%) became disabled in childhood. Fourteen patients need the constant care and control from caregivers; 24 patients were able to work in special conditions, 20 patients can live independently and support themselves; 57 patients lived with parents and 1 patient was married. It has been concluded that notwithstanding the intensive psychopharmacotherapy and rehabilitative programs, patients with early-onset schizophrenia show poor outcomes. Therefore, new social-therapeutic approaches for providing care to these patients are needed.