Moving from Compliance to Competency for the Clinical Research Professional

Transcription

1 Click to Edit Master Title Style Moving from Compliance to Competency for the Clinical Research Professional Rebecca Li, PhD, Executive Director Building A Learning Community Among Key Stakeholders - 1 -

2 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

3 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

4 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, transcultural human subjects research. 4

5 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

6 In 2012 Initiated a Workgroup for Clinical Research Training to Address: 1. Tremendous variation in skills and experience of PIs and coordinators worldwide 1. Training programs are not typically modified or tailored to suit specific regional (geographic) or cultural requirements. 2. Lack of metrics to establish correlation between PI certification or training and improvements in the quality and efficiency of clinical research. 3. Lack of guidelines for core competencies that must be obtained by investigators prior to conducting clinical research. Co-chairs: SHEILA CLAPP (FHI) SARAH CARTER (Amgen) Mohanish Anand (Pfizer) Tracy Blumenthal (Rapidtrials Ann Claiborne (IOM) Amy Davis (PRMR) Kim Havens (PPD) Anna Ravdel (Synergy) Jim Thomasell (ACRP) Jennifer Webb (DIA) Helmut Wolf (Novartis) Mark Barnes (MRCT) ad hoc Barbara Bierer (MRCT) ad hoc Marc Wilenzick (MRCT) ad hoc 6

7 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

8 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 8

9 Personnel who conduct clinical trials What does ICH say? ICH 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) 9

10 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 10

11 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? 11

12 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 12

13 Evolution of Education and Training in Clinical Research 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 Continuing Professional Dev. (CPD) 13 H. Silva, 2010

14 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 14

15 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 15

16 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 16 High quality efforts, but approach of each group has been focused on a specific component of the clinical research enterprise

18 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). 18

19 Joint Task Force for Clinical Trial Competency Contributors and Collaborators 19 Joint Task Force for Clinical Trial Competency

20 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 20

21 We developed a three step approach to harmonize competencies 3 Obtain endorsement 1 Identify competency domains Competency Domains are broad categories of knowledge, skills and attitudes which are necessary to successfully function within a field of expertise 2 Map and define competencies Competencies are specific knowledge, skills and attitudes which comprise Competency Domains Categorize competencies, learning objectives and statements from on-going efforts Define competency statements for each category Obtain endorsement from major stakeholders and content providers Joint Task Force for Clinical Trial Competency 21

22 Competency Domains were defined by reviewing and aligning documents of on-going efforts 1 Identify competency domains Documents were reviewed from on-going efforts Academy of Physicians in Clinical Research Association of Clinical Research Professions Clinical & Translational Science Awards Collaborative Institutional Training Initiative Consortium of Academic Programs in Clinical Research Global Health Network Inter-American Foundation for Clinical Research International Academy of Clinical Research International Federation of Associations of Pharmaceutical Physicians Multi-Regional Clinical Trials TransCelerate UK Clinical Research Collaboration and eight Competency Domains were defined Scientific Concepts and Research Design Ethical Considerations, Patient Care and Safety Medicines Development and Regulation Clinical Trial Operations Study and Site Management Data Management and Informatics Leadership and Professionalism Communication & Teamwork Competency Domains are a broad categories of knowledge, skills and attitudes which are necessary to successfully function within a field of expertise 22 Joint Task Force for Clinical Trial Competency

23 2 Competency statements are defined from grouping similar statements from on-going efforts Map and define competencies Similar statements are grouped together Ethical Considerations, Patient Care and Safety Evaluates and applies the regulatory and ethical aspects underpinning clinical development The Competency Statement is mapped to a Competency Domain Describe the historical development of regulations associated with the protection of human subjects Describe cultural and social variation in standards of research integrity Develop a personal statement on professional ethics and behavior as a clinical research Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards A Competency to align similar statements is defined Competencies are specific knowledge, skills and attitudes which comprise Competency Domains 23 Joint Task Force for Clinical Trial Competency

24 Competency Domains for the Clinical Research Professional Encompasses all elements of communication within the site and between the site and sponsor, CRO and regulators. Understanding of teamwork skills necessary for conducting a clinical trial The principles and practice of leadership and professionalism in clinical research Leadership and Professionalism Communication & Teamwork Scientific Concepts and Research Design Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials Ethical Considerations, Patient Care and Safety Encompasses care of patients, aspects of human subject protection and safety in the conduct of a clinical trial PLEASE TAKE A HANDOUT Covers how data is acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database Data Management and Informatics Study and Site Management Clinical Trials Operations (GCP s) Medicines Development and Regulation Covers knowledge of how drugs are developed and regulated Includes content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory / GCPs) Covers study management and GCP compliance; safety management (AE identification and reporting, post market surveillance and PV) and handling of investigational product 24 Joint Task Force for Clinical Trial Competency 24

25 Core Competencies 25 Joint Task Force for Clinical Trial Competency 25 PLEASE TAKE A HANDOUT

27 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 clinical researcher PI or study coordinator Each competency should be interpreted based your current role Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards 27 Joint Task Force for Clinical Trial Competency 27

28 Competencies by Role Clinical Trial Operations Domain PI Clinical Research Coordinator (CRC) Monitor (CRA) Evaluate the conduct and management of clinical trials within the context of a Clinical Development Plan Required Required Required Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines Evaluate the design conduct and documentation of clinical trials as required for compliance with Good Clinical Practice Guidelines Required Optional Required Required Optional Required PLEASE TAKE HANDOUT 28 Joint Task Force for Clinical Trial Competency 28

29 Harmonized competencies can be used as the basis for various end-uses Education Streamlining educational requirements Investigator Selection Defining criteria for investigator selection Job Descriptions Standardizing job descriptions Development of Accreditation standards Defining standards for accreditation Site Qualification Defining criteria for site selection and qualification Training Requirements Standardizing and streamlining training requirements 29 Joint Task Force for Clinical Trial Competency 29

30 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

31 New approaches to professional development The questions for Life Long Learning What competences do I need for my work and what are the gaps? What learning opportunities can help me? How can I consolidate the learning and become competent 31

32 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,

33 Job/Role Specific Professional Development Pathways 33

34 Professional Pathways Competencies in Action A real life example ACRP Professional Development Pathways 34

35 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

36 Professional Pathways Mastery Levels 36

37 Professional Pathways Instructional Levels 37

38 Professional Pathways Example CRC Pathway/Regulatory and Ethics 38

39 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. 39

40 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 40

41 Thank you! REBECCA LI, PHD 41