MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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Moving from Compliance to Competency for
the Clinical Research Professional
Rebecca Li, PhD, Executive Director
Building A Learning Community Among Key Stakeholders
-1-
Learning Objectives for Today
• How to assess your training needs and gaps based on
the core competency framework
• Recognize practical uses for the core competency
statements
• Assess the relevance of harmonized clinical research
core competencies to your own professional
circumstances
2
Agenda for today
• Current state of clinical research training and unmet
needs
• Development of a Harmonized set of Core
Competencies
• Educational Needs Assessment using the set of Core
Competencies
3
Collaborating to Improve Multi Regional Clinical Trials
The MRCT Center’s Purpose is… To improve the design, conduct, and oversight of multi-regional clinical trials,
especially trials sited in or involving the developing world; to simplify research through the use of best
practices; and to foster respect for research participants, efficacy, safety and fairness in transnational, trans-
cultural human subjects research.
4
Harvard MRCT Clinical Researcher Training
Project - Objective and Problem Statement
Problem statement:
• Many PIs and study staff have little to no formal training in
research design, ethics or GCP
• No currently available list of internationally recognized
standards or competencies currently exists
Objective:
• Develop a single list of minimum clinical trial training
elements that can be endorsed by other groups and utilized
for training and site qualification purposes
5
In 2012 – Initiated a Workgroup for Clinical Research
Training to Address:
1. Tremendous variation in skills and
experience of PIs and coordinators worldwide Co-chairs:
SHEILA CLAPP (FHI)
SARAH CARTER (Amgen)
1. Training programs are not typically modified
or tailored to suit specific regional Mohanish Anand (Pfizer)
(geographic) or cultural requirements. Tracy Blumenthal (Rapidtrials
Ann Claiborne (IOM)
Amy Davis (PRMR)
2. Lack of metrics to establish correlation Kim Havens (PPD)
between PI certification or training and Anna Ravdel (Synergy)
Jim Thomasell (ACRP)
improvements in the quality and efficiency of Jennifer Webb (DIA)
clinical research. Helmut Wolf (Novartis)
Mark Barnes (MRCT) – ad hoc
3. Lack of guidelines for core competencies that Barbara Bierer (MRCT) – ad hoc
Marc Wilenzick (MRCT) – ad hoc
must be obtained by investigators prior to
conducting clinical research.
6
Medicines Development and Clinical Research are among the
most highly regulated activities on a global basis
• Governmental regulatory authorities
• ICH – GCPs
• IRB/IEC
• Pharmacovigilance
• Data Safety Monitoring Boards
7
Personnel who conduct clinical trials
• Very general requirements
• In most countries, anyone with a medical license
can serve as a PI ….irrespective of experience or
education in clinical research
• Little detail in regulatory authority definitions of
criteria required for responsible individuals
8Personnel who conduct clinical trials –
What does ICH say?
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)
9New Regulations
Declaration of Helsinki (Revised 2013)
“Medical Research involving human subjects must be conducted only by individuals with the appropriate
ethics and scientific education, training and qualifications….
FDA Guidance for Investigators, IRBs and
Sponsors(2013)
“The IRB needs to assess the investigator’s training and experience specifically related to the proposed
study……and the determination that the investigator is qualified may need a review of the
investigator’s previous specific experience….and prior clinical experience
Gradual realization on the need for leveraged credentials
and qualifications through education and training
10What are we expecting when we hire a
clinical research professional?
– Principal investigator – Any licensed physician in US or
Europe can serve as a 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?
11Education and Training in Clinical Research –
How is training done now?
Mentoring
Academic Programs
Medical Schools – very little
Pharmatrain – EU
CTSA – oriented toward investigator initiated trials
Graduate/Undergraduate Program in Clinical Research
Administration/Regulatory Affairs/Clinical Data Management
Professional organizations
ACRP, DIA, SoCRA, SCDM, RAPS – professional societies
12Evolution of Education and Training in
Clinical Research
• Informal training: coaching, tutoring
• Short term courses: how to do it
Activity • Professional bodies (training, support)
• Academic involvement: Standards and competencies
• Formal Curriculum: short and long term programs
Discipline • National accreditation and certification
• International Standards/Harmonization of
Training/mutual recognition
• International Certification/Specialization?
Profession • Maintenance through Continuing Professional Dev. (CPD)
H. Silva, 2010
13Training vs. Competence
Although one can infer that
education and training will
enhance the level of regulatory
compliance, we have been unable
to translate this into a
measurement of competence
14Moving from a focus on regulatory compliance
to a focus on professional competency
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
Consider required personnel certification
15Groups related to the clinical research enterprise have
published brought this message to light.
National Center for Advancing Translational Sciences -core competencies
for translational research scientists,
International Federation of Associations of Pharmaceutical Physicians and
the Academy of Physicians in Clinical Research - listings of core
competencies for pharmaceutical physicians and clinical investigators
Consortium of Academic Programs in Clinical Research - core
competencies for graduates of academic programs to guide curriculum
development
Association of Clinical Research Professionals - career development
pathway for CRCs, CRAs and investigators which incorporates competency
statements
Regulatory Affairs Professions Society core competency statements
High quality efforts, but approach of each group has been focused on a specific component
of the clinical research enterprise
16Agenda for today
• Current state of clinical research training and unmet
needs
• Development of a Harmonized set of Core
Competencies
• Educational Needs Assessment using the set of Core
Competencies
17To bring together these disparate, but high quality
efforts focused on clinical trial competence …
Meeting of representatives was hosted by the Multi-Regional
Clinical Trial Center at Harvard University during Spring, 2013:
• pharmaceutical companies
• contract research organizations
• academic institutions
• clinical research sites
• professional societies
A broad based and widely representative group was
formed and named the Joint Task Force for Clinical Trial
Competency (JTF).
18Joint Task Force for Clinical Trial Competency
Contributors and Collaborators
19 Joint Task Force for Clinical Trial CompetencyJoint Task Force for Clinical Trial Competency
Contributors and Collaborators
agreed to work toward aligning and
harmonizing the many more focused
statements relating to core competency
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
competency throughout the clinical
research enterprise
20We developed a three step approach to
harmonize competencies
3
Obtain
endorsement
2
Obtain endorsement from major
Map and define
stakeholders and content
competencies providers
1
Competencies are specific
Identify competency
knowledge, skills and attitudes
domains
which comprise Competency
Domains
Competency Domains are Categorize competencies,
broad categories of learning objectives and
knowledge, skills and statements from on-going
attitudes which are necessary efforts
to successfully function Define competency
within a field of expertise statements for each category
21
21 Joint Task Force for Clinical Trial CompetencyCompetency Domains were defined by reviewing and
aligning documents of on-going efforts
1
Identify competency domains
… and eight Competency Domains were defined
Documents were reviewed from on-going
efforts…
Scientific Concepts and Study and Site
Academy of Physicians in Clinical Research Research Design Management
Association of Clinical Research Professions
Clinical & Translational Science Awards
Collaborative Institutional Training Initiative
Ethical Considerations, Data Management and
Consortium of Academic Programs in Clinical Patient Care and Safety Informatics
Research
Global Health Network
Inter-American Foundation for Clinical Research
Medicines
International Academy of Clinical Research Leadership and
Development and
Professionalism
International Federation of Associations of Regulation
Pharmaceutical Physicians
Multi-Regional Clinical Trials
TransCelerate Communication &
Clinical Trial Operations
UK Clinical Research Collaboration Teamwork
Competency Domains are a broad categories of knowledge, skills and attitudes
22 which are necessary to successfully function within a field of expertise
Joint Task Force for Clinical Trial CompetencyCompetency statements are defined from grouping
similar statements from on-going efforts
2
Map and define
competencies
Ethical Considerations,
Patient Care and Safety
Similar statements are grouped together
Evaluates and applies the The Competency Statement is
regulatory and ethical aspects mapped to a Competency
underpinning clinical development
Domain
Describe the historical Describe the ethical issues
development of regulations
associated with the protection
involved when dealing
of human subjects with vulnerable
populations and the need
Describe cultural and social for additional safeguards
variation in standards of
research integrity
Competencies are
Develop a personal statement on specific knowledge,
professional ethics and behavior A Competency to align similar skills and attitudes
as a clinical research statements is defined which comprise
Competency Domains
23 Joint Task Force for Clinical Trial CompetencyCompetency Domains for the Clinical Research
Professional
Encompasses all elements of communication
within the site and between the site and Encompasses knowledge of scientific concepts
sponsor, CRO and regulators. Understanding of related to the design and analysis of clinical trials
teamwork skills necessary for conducting a
clinical trial
Scientific
Communication Concepts and
& Teamwork Research
Design Encompasses care of patients,
The principles and practice of aspects of human subject
leadership and protection and safety in the
Ethical
professionalism in clinical conduct of a clinical trial
Leadership and Considerations,
research
Professionalism Patient Care and
Safety
PLEASE TAKE A
HANDOUT
Covers how data is acquired and Data Management Medicines
managed during a clinical trial, and Informatics Development and
including source data, data entry, Regulation Covers knowledge of how drugs
queries, quality control, and are developed and regulated
correction and the concept of a
locked database Clinical Trials
Study and Site
Operations
Management
(GCP’s)
Includes content required at the site level to run a Covers study management and GCP compliance;
study (financial and personnel aspects). Includes safety management (AE identification and reporting,
site and study operations (not encompassing post market surveillance and PV) and handling of
regulatory / GCPs) investigational product
24 Joint Task Force for Clinical Trial Competency
24Core Competencies PLEASE TAKE A HANDOUT 25 Joint Task Force for Clinical Trial Competency 25
Agenda for today
• Current state of clinical research training and unmet
needs
• Development of a Harmonized set of Core
Competencies
• Educational Needs Assessment using the set of Core
Competencies
26An example of application
Ethical Considerations, Patient Care and Safety
Encompasses care of patients, aspects of human subject protection and safety in
the conduct of a clinical trial
IRB
member
Sponsor –
PI or study
clinical
coordinator
researcher
Describe the ethical
issues involved
Each competency should be when dealing with
interpreted based your current vulnerable
populations and the
role need for additional
safeguards
27
27 Joint Task Force for Clinical Trial CompetencyCompetencies by Role
Clinical Trial Operations Domain PI Clinical Research Monitor (CRA)
Coordinator (CRC)
Evaluate the conduct and Required Required Required
management of clinical trials
within the context of a Clinical
Development Plan
Describe the roles and Required Optional Required
responsibilities of the clinical
investigation team as defined by
Good Clinical Practice Guidelines
Evaluate the design conduct and Required Optional Required
documentation of clinical trials
as required for compliance with
PLEASE TAKE HANDOUT
Good Clinical Practice Guidelines
28 Joint Task Force for Clinical Trial Competency
28Harmonized competencies can be used as the basis for
various end-uses
Streamlining
Investigator Defining criteria for
Education educational
Selection investigator selection
requirements
Development of
Standardizing job Defining standards
Job Descriptions Accreditation
descriptions for accreditation
standards
Defining criteria for Standardizing and
Training
Site Qualification site selection and streamlining training
Requirements
qualification requirements
29 Joint Task Force for Clinical Trial Competency
29Harmonized Core Competencies for the Clinical
Research Professional
52 specific competencies within the 8 domains derived from
the published and presented efforts of specific 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 utilized
as a basic framework to produce the more granular and
specific competency statements which include knowledge,
skills and attitudes which define the many roles which exist
in the clinical research enterprise
30New approaches to professional development
The questions for Life Long Learning
What competences How can I
What learning
do I need for my consolidate the
opportunities can
work and what are learning and become
help me?
the gaps? “competent”
31Simultaneous Publication of the
Framework
Harmonized Core
Competencies for the Clinical
Research Professional:
The Joint Task Force, 2014
Sonstein S et al, The Monitor June, 2014
32Job/Role Specific Professional
Development Pathways
33Professional Pathways
• Competencies in Action – A real life example
– ACRP Professional Development Pathways
34Professional Pathways
• Competencies in Action – A real life example
– ACRP Professional Development Pathways
• Incorporated in and aligned with the eight (8) global
levels of competency as identified by the taskforce
• Next step -> Three pathways - Job/ role specific!
– CRA, CRC and PI
• What?
– Identifies the knowledge/skills the CRA, CRC and PI need and
when
– A roadmap for professional development (training)
35Professional Pathways
• Mastery Levels
36Professional Pathways
• Instructional Levels
37Professional Pathways
• Example CRC Pathway/Regulatory and Ethics
38Joint Task Force Future initiatives
mission of this JTF initiative has been to bridge the gap between
“what to do” and “how to do it
a universally applicable, globally relevant framework now exists
which identifies the Competency Domains and the associated
cognitive skills necessary to conduct a high quality, ethical and safe
clinical trial.
eventually to approach the regulatory bodies of the world for
recognition and acknowledgment of the Core Competency
Framework and to ultimately house the document and its future
evolutions within the International Conference on Harmonization
as a guideline similar to the E6 Guideline for Good Clinical Practice.
39Summary – How can you use the framework?
• Explain how the eight levels of competency as identified by
the Taskforce can be applied to your specific job and roles
• Consider the advantage of having (role specific)
competencies as a standard to set up certification exams
• Consider how the framework may be used to standardize job
descriptions for your department
• Standardize training requirements for your team
40Thank you!
REBECCA LI, PHD
Rebecca_li@harvard.edu
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