Harmonized Core Competencies in Clinical Research: evolutions and next steps for meeting the challenge

Transcription

1 Harmonized Core Competencies in Clinical Research: evolutions and next steps for meeting the challenge Master of Applied Clinical and Preclinical Research macpr.osu.edu Consortium of Academic Programs in Clinical Research Carolynn Thomas Jones, DNP, MSPH, RN Assistant Professor of Clinical Nursing, Ohio State University Lead Instructor, Masters of Applied Clinical and Preclinical Research President Consortium of Academic Programs in Clinical Research Member Joint Task Force for Clinical Trial Competence

2 Objectives Preparation for workgroup action: Define gaps effecting the clinical research workforce Illustrate evolution of clinical research competencies by CoAPCR Review Joint Task Force Harmonized Core Competencies and Survey Applying the JTF Framework to roles and curriculum

3 Defining Competency Based Learning for.... Clinical Research Workforce (aka Implementers ) Roles have evolved in the past 30 years Issues (Gaps) No formal training Role Uncertainty Murky identity (Medicine : Nursing) Job titles Tensions: Ethical, Clinical, Technical, Cultural Professionalization Transition: Delegation to Specialization Identified NEED for CR Workforce Development Mueller, M. (2001). From delegation to specialization: nurses and clinical trial coordination. Nursing Inquiry; 8(3):

4 1970s 1980s 1990s

5 2001

6

7 Consortium of Academic Programs in Clinical Research Facilitates the development of high quality educational programs encompassing all areas of clinical research that are based in academic credit granting institutions. Founded Origins: 7 Institutions (Duke, Louisville, GWU, Campbell, East. Mich., Univ. New South Wales) 20+ Member institutions ($100/yr): Certificate AD BS MS (? CTSAs) Alliances: ACRES, ACRP, SoCRA, RAPS, SCDM, ACPR, JTF Facilitate communication and excellent curriculum across programs Foster inter institutional and association articulation Support, foster research related to CR Workforce Education Establish program accreditation 2003 coapcr.org

8 Consortium of Academic Programs in Clinical Research Founded Finalizing Core Competencies Application to CAAHEP Formed a Commission on Accreditation (CoA) Adopted JTF Competencies CoA Defined Standards for Accreditation CoA Defining Self Study Criteria Begin Accreditation coapcr.org

9 2010

10 Defining Core Competencies in Clinical Research Modified Delphi Approach to Harmonizing MD PI and CRN Resources Influencing Curriculum Standards Pathway to Educational Program Accreditation (CAAHEP) MD PI ORIENTED COMPETENCIES NCATS/CTSA Competencies Academy of Physicians in Clinical Research (APCR) International Federation of Associations of Pharmaceutical Physicians (IFAPP) CRN ORIENTED COMPETENCIES NIH CRN 2010 Domains of Practice International Association of Clinical Research Nurses Oncology Nursing Society CRN Competencies UK Competency Framework Working Group (NHS, Royal College of Nursing)

11 Jones, C.T., et al. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 13(3), Sonstein, S., Silva, H., Jones, C.T. (2012). Harmonization of core competencies across the clinical research enterprise to help enhance the quality of clinical trials and the personnel who conduct them. In Program and Abstracts of the 48th Annual Meeting of the Drug Information Association, Philadelphia PA.

12 JOINT TASK FORCE FOR CLINICAL TRIAL COMPETENCE Content Providers Collaborators Academy of Physicians in Clinical Research Association of Clinical Research Professions Clinical & Translational Science Awards Alliance for Clinical Excellence and Safety Clinical Trials Transformation Initiative Amgen Collaborative Institutional Training Initiative Consortium of Academic Programs in Clinical Research Global Health Network Deloitte Drug Information Association MAGI Inter American Foundation for Clinical Research International Academy of Clinical Research International Federation of Associations of Pharmaceutical Physicians Pfizer PharmaTrain Korea National Enterprise for Clinical Trials 2013 Hosted by Multi Regional Clinical Trials Center at Harvard University Multi Regional Clinical Trials TransCelerate UK Clinical Research Collaboration Joint Task Force for Clinical Trial Competency

13 1 Competency Domains were defined by reviewing and aligning documents of on going efforts Identify competency domains Competency Domains are a broad categories of knowledge, skills and attitudes which are necessary to successfully function within a field of expertise 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 Joint Task Force for Clinical Trial Competency

14 Harmonized Core Competencies 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 Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials The principles and practice of leadership and professionalism in clinical research Encompasses care of patients, aspects of human subject protection and safety in the conduct of a clinical trial 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 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 Joint Task Force for Clinical Trial Competency

15 DOMAIN 1 SCIENTIFIC CONCEPTS AND RESEARCH DESIGN Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials Demonstrate knowledge of pathophysiology, pharmacology and toxicology as they relate to medicines discovery and development Identify clinically important questions that are potentially testable clinical research hypothesis, through review of the professional literature Design a clinical trial Critically analyze study results with an understanding of therapeutic and comparative effectiveness Explain the elements (statistical, epidemiological and operational) of clinical and translational study design Joint Task Force for Clinical Trial Competency

16 JTF Handout: Competencies Per Domain Sonstein, S.A., Seltzer, J., Li, R., Jones, C.T., Silva, H., Daemen, E. (2014). Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clinical Researcher. 28(3); Applied Clinical Trials. May 28, Journal of Clinical Research Best Practices 10(6); 1 12 CenterWatch Whitepapers, June, 2014 Archivos Venezolanos de Farmacologia y Terapeutica Joint Task Force for Clinical Trial Competency

17 JTF Core Competency Survey Objectives Utilization of JTF CC Framework as: 1. Self Assessments for CRPs 2. Educational needs assessment 3. Role delineation across clinical research teams. This survey has IRB Approval from Eastern Michigan University. Survey Monkey Three questions per Competency Current Level of Competence (0 4) Significance to my Position (0 4) Need for Additional Training (Y/N)

18 JTF Core Competency Survey Distributed broadly in: US (CoAPCR & AMCs/CTSA) UK Australia Latin America India (just commencing) Excellent distribution support: CoAPCR, NHS (UK); ACRES, ACRP, AMC/CTSA Sites Currently over 800 responders Open through March 2015 Extended (India) Utilization: Standardize job descriptions Training needs assessment Educational Program Content Workforce definitions

19 Core Competencies Novice to Expert (Levels) Roles Clinical (+/ ) Licensure (+/ ) Education Experience Genetics! Level I Level 2 Competent with supervision Level 3 Competent, autonomous, minimal assistance and supervision Level 4 Expert Supports, trains and supervises others Novice, assistance & supervision

20 Mapping Site Roles to Core Competencies DOMAIN Competency Job Title/Role: Nurse CRC Level I Clinical Research Nurse I Level 2 Clinical Research Nurse Coordinator Level 3 Sr. Clinical Research Nurse Coordinator Level 4 Research Nurse Manager Job Descriptions Competency Tasks Education, Training, Certificates Required

21 Mapping Core Competencies to Curriculum Competency Mapping Sample Core Courses Sample Specialty Courses Competency: 1a... x x x x x Competency: 1b.. x Competency: 1c.. x x x Competency: 1d.. x x x x

22 Mapping Core Competencies to Curriculum Competency Mapping Core Courses Specialty Courses Competency: 1a.. x x x x Competency: 1b.. x Competency: 1c.. x x x Competency: 1d.. x x x x Per Course Competency based learning objectives Summative and Effective Learning Deliverables: Tests Written Assignments Projects Learning Outcomes/Competency E Portfolios

23 Why are we here? Persistent Gaps Bridge Challenge 2020 No formal training Murky identity (Medicine : Nursing) Job titles Role Uncertainty Tensions: Ethical, Clinical, Technical, Cultural Professionalization Persistent FDA findings!

24 We envision a need for a clinical research workforce organized in several dimensions that reflect the broad missions of the Clinical Trial Enterprise, the specific disciplines involved, and the level of desirable expertise (p. 161). Bonham, A., Califf, R., Gallin, E.(2012). Developing a robust clinical trial workforce. In: Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for National Academies Press: Washington DC.

25 Core Courses are mapped to the JTF Framework This interdisciplinary master s degree is a collaboration of The Ohio State University Colleges of Nursing, Pharmacy, Medicine, and Veterinary Medicine. The program was established with the support of the OSU Center for Clinical and Translational Science.

26 Q & A Master of Applied Clinical and Preclinical Research Preparing graduates to excel as effective members of interdisciplinary clinical and preclinical research macpr.osu.edu Carolynn Thomas Jones, DNP, MSPH, RN Jones.5342@osu.edu