1 ICPM2018 INTERNATIONAL PERCEPTION OF COMPETENCE Needs For Clinical Research Education Stephen Sonstein, PhD Honorio Silva, MD
Survey Objectives To validate JTF domains/competencies through perceptions of clinical research professionals. How do the competencies relate to: • Roles, Job Titles • Perceptions of competence and relevance • Educational Levels • Educational Needs • Identify gaps for future study and workforce development
3 Demographics by region and function Role # Regional Participants Clinical Research 559 (n=1584) Asia/Australia 4% Coordinator/Research Nurse Research Administrator/Project 357 Manager Western Europe 24% Principal Investigator/Co- 354 investigator Clinical Research 177 Latin Associate/Monitor America/Caribbean 41% Regulatory Affairs Professional 90 US/Canada Data Management Professional 47 31% Others 154 Total 1738
4 Scale of Self-Assessed Responses Competence: 0 Never been exposed to this content 1= Aware of the content, but never needed to become further informed; 2= Exposed and sufficiently aware of content that I can look up what might be necessary for my job; 3= Competent – Able to interpret or discuss concepts and use knowledge to solve simple problems based on application concepts; 4 = Mastery – able to apply knowledge to complex problems, integrate information and create solutions Relevance: 0 = unnecessary, no relevance to my role; Scale Rearrangements for Statistical Anaysis 1 = has some relevance to my role, but not my responsibility; 2 = relevant to my role, but not a major component; 3 = significant to my role and part of my job responsibilities; 4 = major part of my responsibility or supervisory expectations
Perceived need for training Domain Need for Training (% yes ) PI CRA CRC RM Scientific Concepts and Research Design 61 57 48 44 Ethical and Participant Safety Considerations 51 52 48 44 Medicines Development and Regulation 58 58 50 38 Clinical Trial Operations 53 52 45 36 Study and Site Management 62 57 56 48 Data Management and Informatics 60 53 45 36 Leadership and Professionalism 62 62 55 52 Communication and Teamwork 57 57 48 45
6 ICPM2018 Medicines Development and Scientific Concepts and Research Design Regulation Low levels of competence/relevance in High level of competence/relevance in all regions, but even lower in Asia Latin America; low in Western Europe 0.6 0.7 0.6 Current Level 0.5 of Competence 0.5 Current Level of 0.4 Significance Competence to my 0.4 Position 0.3 0.3 Significance of my Position 0.2 0.2 0.1 0.1 0 0 Asia/Australia Latin America USA/Canada Western Europe Asia/Australia Latin America and USA/Canada Western Europe (n = 65) and the (n = 489) (n = 377) (n = 65) the Caribbean (n = 489) (n = 377) Caribbean (n = 653) (n = 653) ANOVA: Comparison between regions, *p<0.05, **p<0.01, *** p< 0.001
7 ICPM2018 Ethical and Participant Safety Clinical Operations Domain Considerations Higher perception of 0.8 competence/relevance in Latin America 0.9 0.7 Current Level of Competence 0.8 0.6 Significance to 0.7 my Position 0.5 0.6 0.4 0.5 Current Level of Competence 0.3 0.4 Significance of 0.3 my Position 0.2 0.2 0.1 0.1 0 0 Asia/Australia Latin America and USA/Canada Western Europe (n = 65) the Caribbean (n = 489) (n = 377) Asia/Australia Latin America USA/Canada Western Europe (n = 653) (n = 65) and the (n = 489) (n = 377) Caribbean (n = 653)
8 ICPM2018 Data Management and Study and Site Management Informatics Lower competence/relevance in Western Europe Lower competence/relevance in Asia 0.8 0.7 Current Level of 0.7 Competence 0.6 0.6 Significance of 0.5 my Position 0.5 0.4 Current Level of 0.4 Competence 0.3 0.3 Significance of my Position 0.2 0.2 0.1 0.1 0 Asia/Australia Latin America and USA/Canada Western Europe 0 (n = 65) the Caribbean (n = 489) (n = 377) (n = 653) Asia/Australia Latin America USA/Canada Western Europe (n = 65) and the (n = 489) (n = 377) Caribbean (n = 653)
9 ICPM2018 Communication and Leadership and Professionalism Teamwork Lower relevance in the USA and Europe *** 0.9 0.8 *** 0.8 0.7 Current Level 0.7 Current Level 0.6 of Competence of Competence 0.6 0.5 0.5 Significance of 0.4 0.4 Significance of my Position my Position 0.3 0.3 0.2 0.2 0.1 0.1 0 0
Comments to regional differences • Need to confirm regional findings (focus groups) or surveys among representative samples from participating countries • Need to explore further according to source of employment (academic, industry, CROs) • Questionnaire was conducted in English. Need for language validation to confirm full understanding of the individual competency • In spite the large sample size, internal regional demographics could skew the interpretation of results • Several hypothesis can be formulated
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