INTERNATIONAL PERCEPTION OF COMPETENCE Needs For Clinical Research - - PowerPoint PPT Presentation

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INTERNATIONAL PERCEPTION OF COMPETENCE Needs For Clinical Research - - PowerPoint PPT Presentation

Oct 21, 2022 222 likes •340 views

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.

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SLIDE 1

INTERNATIONAL PERCEPTION OF COMPETENCE

Needs For Clinical Research Education

Stephen Sonstein, PhD Honorio Silva, MD

ICPM2018

1

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SLIDE 2

Survey Objectives

To validate JTF domains/competencies through perceptions

  • f 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
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SLIDE 3

Demographics by region and function

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Role

#

Clinical Research Coordinator/Research Nurse

559

Research Administrator/Project Manager

357

Principal Investigator/Co- investigator

354

Clinical Research Associate/Monitor

177

Regulatory Affairs Professional

90

Data Management Professional

47

Others

154

Total

1738

Asia/Australia 4% Latin America/Caribbean 41% US/Canada 31% Western Europe 24%

Regional Participants (n=1584)

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SLIDE 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;

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 4

Scale Rearrangements for Statistical Anaysis

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SLIDE 5

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

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Scientific Concepts and Research Design

Medicines Development and Regulation

ICPM2018

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0.1 0.2 0.3 0.4 0.5 0.6 0.7

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level

  • f

Competence Significance to my Position

0.1 0.2 0.3 0.4 0.5 0.6

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level of Competence Significance of my Position

High level of competence/relevance in Latin America; low in Western Europe Low levels of competence/relevance in all regions, but even lower in Asia

ANOVA: Comparison between regions, *p<0.05, **p<0.01, *** p< 0.001

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SLIDE 7

Ethical and Participant Safety Considerations Clinical Operations Domain

ICPM2018

7

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level

  • f Competence

Significance to my Position 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level of Competence Significance of my Position

Higher perception of competence/relevance in Latin America

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SLIDE 8

Study and Site Management Data Management and Informatics

ICPM2018

8

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level of Competence Significance of my Position

Lower competence/relevance in Asia

0.1 0.2 0.3 0.4 0.5 0.6 0.7

Asia/Australia (n = 65) Latin America and the Caribbean (n = 653) USA/Canada (n = 489) Western Europe (n = 377)

Current Level of Competence Significance of my Position

Lower competence/relevance in Western Europe

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SLIDE 9

Leadership and Professionalism

Communication and Teamwork

ICPM2018

9

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Current Level

  • f Competence

Significance of my Position 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 Current Level

  • f Competence

Significance of my Position

Lower relevance in the USA and Europe

*** ***

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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