The paradigm of the professional education program “Clinical Research Management”

Abstract

Aim. To substantiate the need to develop professional management knowledge essential to conduct clinical research in Ukraine, as well as develop the paradigm of the professional education program “Clinical Research Management”. Materials and methods. Scientific and statistical publications, as well as the results of a questionnaire survey designed to interview specialists working for medical and scientific institutions were used as research materials; the methods of systematization of theoretical and practical materials, content analysis, generalization of the survey results were applied. Results. The relevance of the professional education program “Clinical Research Management” has been substantiated based on scientific literature and recommendations of professional organizations for conducting clinical studies in healthcare. The questionnaire survey of specialists working for medical and scientific institutions has shown their participation in planning, organizing, and controlling the clinical studies. The results of the survey have demonstrated that a significant part of the specialists is involved directly in the clinical studies at different phases; it actualizes the need for professional knowledge on modern management. The study has revealed that all categories of specialists interviewed create the demand for an advanced training or additional education in the field of management. However, medical specialists and researchers are the most interested in gaining new knowledge. Based on the peculiarities of phases of clinical research the paper develops the main learning outcomes that convey the knowledge, skills, and competencies required to conduct clinical research and assure enhanced quality. Conclusions. Taking into account the urgent need for training the specialists who should be able to carry out clinical research in Ukraine the program for training professional clinical research managers has been offered. After completion, the specialist should be able to organize the clinical trials of new drugs, ensure effective allocation of limited resources, develop and implement the quality management system according to the requirements of current standards, carry out audits and manage risks to assure the appropriate quality of clinical research.