From Regulatory Compliance to Competence in Clinical Research

The Joint Task Force for Clinical Research Competency Initiative

Stephen A. Sonstein, PhD

Director, Clinical Research Administration

Eastern Michigan University

Presented to:

11/17/2015

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Expected Learning Outcomes

• Recognize the evolution of clinical research as an academic discipline

• Recognize the growing relevance of competency based education and training in career development

• Describe the outcomes of the Joint Task Force (JTF) initiative to define the Core Competencies in Clinical Research

• Describe the preliminary lessons learned from an international initiative to validate the JTF Core Competencies

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Drug and device development is one of the most highly regulated activities globally

–Governmental regulatory authorities

•FDA

•OHRP

–ICH – GCPs

–IRB/IEC

–Pharmacovigilance

–Comparative efficacy vs cost

Personnel who conduct clinical trials

– Very general requirements

– In most countries, anyone with a medical license can conduct clinical trials….irrespective of their experience or education in clinical research

– Little detail in regulatory authority definitions of criteria required for responsible individuals

• ICH 4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies)

Personnel who conduct clinical trials

– Declaration of Helsinki

• Previous – 3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

• Revised – (2014) 12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

The Harsh Reality of Clinical Research Sites Today

• 70% of clinical research sites never do more than one clinical trial

in the business lifetime

• Fewer than half of sites meet enrollment goals and 10% never

enroll a single subject

• Few sites have professionally trained and certified research

personnel

• Many sites are still using paper records without EDC/CTMS

• Monitoring accounts for nearly one-third of clinical trial budgets

• Redundancy, delays, non-compliance, and poor quality are the

norm rather than the exception

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Clinical Investigator Deficiencies.

CDER Inspections 2004-2011

Enhancing the quality of clinical trials

Deficiencies and Opportunities

Khin NA et al. Clin Pharmacol Therap,2013; 94,2:230 Education and Training

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• Improved trial design principles

• Defined personnel roles and responsibilities

• Improved policies and procedures

• Improved study start-up

• Quality assurance and auditing

• Document management

• Improved adverse event reporting

• Record retentionPerspect Clin Res.

2011 Oct-Dec; 2(4):

124–128.

What are we expecting when we hire a clinical research

professional?

• Principal investigator – Any licensed physician anywhere in the

world can serve as Principal Investigator

• CRC – there are no educational requirements

• CRA – there are no educational requirements

• Regulatory Affairs Professional – there are no educational

requirements

How do we differentiate between an entry level

and an advanced level professional?

What criteria do we use to justify promotion?

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Activity

• Informal training: coaching, tutoring• Short term courses: how to do it!

• Professional bodies (training, support)

Discipline

• Academic involvement: Standards and competencies• Formal Curriculum: short and long term programs• National accreditation and certification

Profession

• International Standards/Harmonization of Training/mutual recognition

• International Certification/Specialization• Maintenance through CPD

Evolution of Education and Training in

Clinical Research

Honorio Silva MD, 2010

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How to do it?

• Systematic harmonization and broad based acceptance

of job descriptions and performance outcomes for the

many roles that exist in the clinical research enterprise

• Standardization and Documentation of

education/ training and experience in clinical research

• Required personnel certification

• Accreditation of the sites which conduct clinical trials

Moving the clinical research enterprise from a focus on

regulatory compliance to professional competence

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Traditional Vs Outcomes Based education

TRADITIONAL EDUCATION OUTCOMES BASED

EDUCATION

Based upon knowledge Based upon competencies

Time fixed; Time is variable

Learners grouped in classes and

move together

Learners advance in various

ways to achieve outcomes

Teachers are responsible for a

course

Teachers are responsible for a

set of outcomes

Learners accumulate courses

and grades lead ing to a

credential

Learners demonstrate

achievement of outcomes at

their own pace

Defined competencies are

important

Defined competencies are a

paradigm 11

Competency vs. Competence

Competencies encompass knowledge, skills, attitudes, and behaviors

necessary for a particular set of tasks or objectives in a specific

job/function

• Are usually organized in clusters (domains)

• Can be measured (assessed)

• Can be improved

A competent professional is one possessing the required abilities in all

domains in a certain context at a defined stage of education or practice.

(Frank J. Medical Teacher, 2010)

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Use of competencies

• Competency profiles

• Competency-based education and training

• Job profiles – linked – personnel profiles

• Level of competency vs level of job

• Self-assessment & competence

• Competence & career development

• Gap analysis

• Training to fill gaps

• Continuous process (competence not static, jobs change,

gaps appear); lifelong learning

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Competence: Self-Assessment

What learning opportunities can help

me?

How can I consolidate

the learning & become

competent?

What competencies

do I need for my work & what are

the gaps?

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The Joint Task Force for Clinical Trial

Competency

• Organized under the sponsorship of MRCT and ACRES at Harvard University.

• Supported by MAGI, DIA and ACRP

• Included representatives from industry, academy and nonprofit organizations

• Agreed to work toward aligning and harmonizing the many more focused statements relating to core competencies for clinical research professionals into a single, high-level set of standards which could be adopted globally and serve as a framework for defining professional competence throughout the clinical research enterprise

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Joint Task Force for Clinical Trial Competency

Contributors and Collaborators

Representatives met in person or via TC during the

period October 2013-June 2015

JTF Coordinators: S. Sonstein and R. Li

Outcomes of the JTF on Core Competencies in Clinical

Research

• 51 specific competencies within the 8 domains derived from the published and presented efforts of specific related groups

• Based upon cognitive parameters

• Not expected that each member of the clinical research enterprise is competent in all

• Still need to be leveled as Expert, Competent, Novice

• Hope is that Harmonized Core Competencies will be u tilized as a basic framework for job descriptions and job portfolios

Sonstein, S.A., Seltzer, J., Li, R., Jones, C.T., Silva, H., Daemen, E. (2014, June). Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clinical Researcher. 28(3)17-23.

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Harmonized Core Competency Domains for the Clinical

Research Professional

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A cooperative multi-institutional effort

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The JTF International Validation of

Core Competencies and Educational

Needs Assessment

Initiative in final stages

•Globally distributed questionnaire including demographics, domains and competencies.

• Respondents were asked to share their own perception of competence, role relevance and needs for training utilizing the JTF Core Competency Domains and statements

• Data to be used for:

• Needs assessment for training

• Standard ization of position descriptions

• Integration into personnel and site certification efforts

• Validation and identification of key competencies

• Standardization of curricula for academic programs

- complete statistical analysis currently ongoing….

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Demographics by region and function

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ONLY 366 CERTIFIED

Role #

Clinical Research

Coordinator/Research Nurse

338

Research Administrator/Project

Manager

229

Principal Investigator/Co-

investigator

228

Clinical Research

Associate/Monitor

129

Regulatory Affairs Professional 52

Educator/Trainer 50

Pharmaceutical Physician/Medical

Director

42

Data Management Professional 38

Others 107

Total 1213

Latin America41%

US/CAN35%

Europe20%

Scale of Self-Assessed Responses to Perception of

Competence and job relevance

Competency Key:

• 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 Key:

•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

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Criteria for Competency Relevance to Role

• Percentage of responses rated 3 or 4

• 1 – High Relevance - >80%

• 2- Significant Relevance – 60-79%

• 3- Intermediate Relevance– 40-59%

• 4- Low Relevance– 20-39%

• 5- No relevance - <20%

• Applied to both domains and specific competencies.

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Self-assessment of Competence, Relevance and Training Needs - Overall

N=1213

Domain Self Assessment of Competence (%)

Relevance to the job (%)

Additional Training Needs (%)

Scientific Concepts

& research design

42 36 51

Ethics & Safety 67 61 43

Medicines Dev. &

regulations

46 40 50

Clin. Trials Ops 68 63 45

Study & Site Mgmt 57 57 55

Data Mgt & inform 59 55 47

Leadership &

professionalism

65 64 55

Communication &

Teamwork

62 57 50

Perception of Competence and Relevance by Role

Domain Relevance to Role (% 3-4) Competency (%3-4)

PI CRA CRC RM PI CRA CRC RM

Scientific Concepts and Research Design 74 34 22 27 76 35 27 39

Ethical and Participant Safety Considerations 81 66 63 54 86 67 67 66

Medicines Development and Regulation 52 42 32 39 52 47 48 50

Clinical Trial Operations 79 76 64 62 79 76 64 73

Study and Site Management 73 54 56 70 67 53 53 74

Data Management and Informatics 72 59 59 49 68 62 59 61

Leadership and Professionalism 83 57 62 70 79 57 61 75

Communication and Teamwork 81 51 55 56 81 55 59 65

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Perceived need for training by role

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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Competency (% 3-4) Relevance (%3-4)

Years of Experience 2-5 6-10 10-19 20+ 2-5 6-10 10-19 20+

Ethical and Participant Safety Considerations

Compare and contrast clinical care and clinical management of research participants (317)

52 63 75 74 44 62 71 68

Define the concepts of “clinical equipoise” and “therapeutic misconception” as they relate to the conduct of a clinical trial (315)

25 39 43 57 21 40 39 55

Compare the requirements for human subject protection and privacy under different national and international regulations and ensures their implementation throughout all phases of a clinical study (315)

56 71 75 74 56 69 77 82

Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key documents which ensure the protection of human participants in clinical research (313)

85 90 93 96 81 85 92 91

Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards (314)

81 88 87 100 74 80 85 86

Evaluate and apply an understanding of the past and current ethical issues, cultural variation and commercial aspects on the medicines development process (313)

39 59 64 82 36 46 59 68

Explain how inclusion and exclusion criteria are included in a clinical protocol to assure human subject protection (313)

84 85 90 95 80 78 83 100

Summarize the principles and methods of distributing balancing risk and benefit through selection and management of clinical trial subjects (313)

59 75 77 89 53 70 73 81

Specific Competency and Relevance to CRC’s by years

of experience

CRC - Perceived competence, relevance and

training need by location

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Domain Location N Competence Relevance Training

% 3+4 % 3+4 % yes

Scientific Concepts and Research Design US/Can 123 31 27 43

LA 36 36 37 75

WE 122 20 16 45

AA 12 28 20 43

Ethical and Participant Safety Considerations US/Can 117 70 64 35

LA 36 59 62 64

WE 120 65 64 40

AA 12 56 59 33

Medicines Development and Regulations US/Can 114 41 41 41

LA 36 35 40 67

WE 118 36 34 53

AA 12 18 12 58

Clinical Trial Operations US/Can 114 68 64 40

LA 36 64 67 72

WE 117 63 63 42

AA 12 46 59 47

Study and Site Management US/Can 113 57 58 54

LA 36 50 59 75

WE 117 63 63 42

AA 12 43 43 51

Data Management and Informatics US/Can 115 64 60 41

LA 36 51 62 72

WE 114 55 57 41

AA 12 58 58 48

Leadership and Professionalism US/Can 116 62 63 49

LA 36 55 66 81

WE 114 61 66 53

AA 12 56 58 54

Communication and Teamwork US/Can 115 59 62 43

LA 36 55 63 68

WE 114 59 57 46

AA 12 64 56 44

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Conclusions

1. Performance deficiencies in the clinical trial process are not only

costly, but contribute to delay and risk in the medicines

development process

2. Competency rather than compliance is the currency by which we

should be measuring the conduct of clinical research and medicines

development

3. Competency based education is emerging as a paradigm for

education and training in health professions

4. The JTF has developed a Harmonized Framework of Core

Competencies for the Clinical Research Professional and a global

survey aimed at validation, perception of competence, relevance to

the job and educational needs was recently completed . Final results

are expected soon.

5. Preliminary data show differences in the perception of competence,

relevance and need for training for the various functions and

competency domains. The significance of such d ifferences is to be

determined.

• Finalize analysis of collected data, and continue with

internal/ external d iscussions with stakeholders

• Ongoing validation and collaboration with the NIH CTSA

network

• Further regional/ country validation

• Formalize the ACRP role as “Custodian”

• Adoption of key competencies for accreditation of academic

programs

• Create global awareness for further adoption and adaptation

• Devise an effective communication strategy

• Identification of job profiles and portfolios.

Next Steps

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Thanks for your attention!

Q & A