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
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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-
MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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.

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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.

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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

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MOVING FROM COMPLIANCE TO COMPETENCY FOR THE CLINICAL RESEARCH PROFESSIONAL - REBECCA LI, PHD, EXECUTIVE DIRECTOR
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

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Personnel 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)
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New 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

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What 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?

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Education 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
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Evolution 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
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Training 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

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Moving 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

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Groups 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
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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

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To 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).

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Joint Task Force for Clinical Trial Competency
            Contributors and Collaborators

19                                        Joint Task Force for Clinical Trial Competency
Joint 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

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We 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 Competency
Competency 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 Competency
Competency 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 Competency
Competency 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
24
Core 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

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An 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 Competency
Competencies 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
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Harmonized 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
29
Harmonized 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
30
New 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”

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Simultaneous 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

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Job/Role Specific Professional
        Development Pathways

33
Professional Pathways

     • Competencies in Action – A real life example
       – ACRP Professional Development Pathways

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Professional 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)

35
Professional Pathways

     • Mastery Levels

36
Professional Pathways

     • Instructional Levels

37
Professional Pathways

     • Example CRC Pathway/Regulatory and Ethics

38
Joint 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.

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Summary – 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

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Thank you!
        REBECCA LI, PHD
     Rebecca_li@harvard.edu

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