Presentation on theme: "Leaning Forward! Emerging Collaborations, Research & Accreditation Carolynn Thomas Jones, RN, MSPH President, Consortium of Academic Programs in Clinical."— Presentation transcript:
Leaning Forward! Emerging Collaborations, Research & Accreditation Carolynn Thomas Jones, RN, MSPH President, Consortium of Academic Programs in Clinical Research (CoAPCR) Faculty, School of Nursing, University of Alabama at Birmingham COAPCR Annual Meeting DIA Convention June 26, 2013 Boston, MA www.coapcr.org
Brief Overview: Define CoAPCR Define: What is clinical research? Present career paths and stakeholders Defining core competencies for APCR www.coapcr.org
Provides a medium for communication among CRP educators Encourages the development of academically based CRP educational programs. Fosters inter-institutional articulation Initiates research, study and discussion relating to the educational, manpower and service needs of CRPs. Offers a mechanism for program accreditation www.coapcr.org
Clinical Research - It’s global. Number of Clinical Trials- March 2013
10,000 25051 FDA Approved Compounds Drug TIME: 15 Years COST: $1.6 Billion What is clinical research and who works in that “world”?
Drug Target ID Discovery Pre- Clinical Phase I Trials Phase II Trials Phase III Trials Phase IV Post- Marketing Biochemist Microbiologist Geneticists Molecular Biologist Pharmacologist Organic Chemist Medicinal Chemist Statistician MD/PhD Bioinformatics Patent attorney Lawyers Project Manager Pharmacologist Immunologist MD Specialist QA/QC Informatics Statistician Toxicologist Chemist Biotechnologist Regulatory Affairs CRCs, PIs CRO, CRA Medical Writing Regulatory Project Managers QA/QC Managers Data Managers Statistician Site IRBs Site Pharmacists Manufacturer Medical Sales Marketing Medical Writing Communication CRCs, PIs CRO, CRAs Project Managers Data Managers Statistician Site IRBs Year 0 15 POTENTIAL STUDENTS
RESEARCH CAREERS EMPLOYERS PharmaCROsGov'tAMCIndep Private MD Medical Director XXXXXX Medical Scientists XXXX Biochemists XXXX Biomedical Engineers XXXX Genetic Engineers XXXX Genetic Counselors XXXXX Molecular Biologists XXXX Research Pharmacists XXXXXX Investigator XXXXXX Process Engineer XXXX Manufacturing XX Packaging, Supply Manager XXXX Information Technologist XXXXXX Quality Analysts XXXX QA Managers XXXXXX Data Managers XXXXXX Data Validators XXXX Quality Auditor XXXXXX Clinical Safety Specialist XXXX Biostatistician XXXX Scientific Writer XXXXXX Clinical Research Associate XXXX Site Monitor XXXX Clinical Research Coordinator XXXXX Research Nurse Manager XXXXX Clinical Research Nurse XXXXX Regulatory Affairs Coordinator XXXXXX IRB Specialist XXXXXX Research Assistant XXXXXX Research Lab Manager XXXXXX Research Recruiter XXXXXX Research Site Educator XXXX Clinical Research Trainer XXXX Project Manager XXXX STAKEHOLDERS Employers of Clinical Research Professionals
1.Shamoo AE, Resnik DB. 2006. Ethical issues for clinical research managers. DIA J.;40:371- 383. 2.Carter, S. C., Jester, P. M., & Thomas Jones, C. (2007). Issues in clinical research manager education and training. Research Practitioner, 8(2):48-60 3.Jones CT, Harrison L, Carter S. Education and training preferences of clinical research managers. 2008. Research Practitioner ; 9(6):201-211. 3.Ekmekci O, Bocchino J, Turley C, Butler J. 2011 Who is a Clinical Research Professional? Monitor; 25(5):11-20. 4.Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor; 25(6):9-15. 5.Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H., Gladson, B., Browning, S. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 13(3), 99-107. Competency-Based Education for Clinical Research Professionals From the Literature
Educational Modalities Used by Clinical Research Professionals Self Study (Books, Articles) Employer Offerings (CEUs) Sponsor Meetings (Project-specific) Private Offerings (Barnett) Professional Organization (Certification) Academic (Certificate, Degrees) On the job training continues to be a primary mode, until something happens! & New Regulatory Requirements
Modified from Table 1 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15. Basic Knowledge Areas (out of 19) Training Needed Ever Received Adequate Training Regulatory Affairs8646 Toxicity Testing6323 Pharmaceutical Development6224 Quality and Audit Issues6332 Drug Safety/Pharmacovigilance8251 Clinical Pharmacology6942 Statistics and Data Management7147 GXPs (eg, GCP, GMP, GLP)8158 Information Technology4222 Ethics and Legal Issues7758
Modified from Table 2 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15. Newer Knowledge and Skills (out of 17) Training Needed Ever Received Adequate Training Translational Medicine8632 Biotechnology6827 Medical Devices4318 Globalization8125 Knowledge Management7626 Critical Thinking6530 Medical Writing5832 Conflict Management6136 Teaching and Training Others5231 Media Skills4329
How can we narrow the learning gaps for clinical research professionals? What is the impact of learning gaps on healthcare costs and public safety ? Education vs training. Importance of critical thinking!
CoAPCR Competency Development Process APPI ACRP NIH-NCRR-CTSA program NIH Clinical Center – Clinical Research Nursing 2010 Oncology Nursing Society Royal College of Nursing (UK) Quality and Safety Education for Nurses (QSEN) IACRN Scopes and Standards CoAPCR Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H., Gladson, B., Browning, S. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 13(3), 99-107. In Tandem!
1. 1. Scientific Concepts and Principles of Research Design 2. 2. Medical Product Development 3. 3. Clinical Study Operation and Regulatory Compliance 4. 4. Ethical Considerations and the Responsible Conduct of Clinical Research 5. 5. Clinical Study and Site Management 6. 6. Data Management and Informatics 7. 7. Communication of Scientific Data 8. 8. Professionalism, Teamwork and Leadership CoAPCR Core Competency Domains KnowledgeSkillsAttitudes Committee on Accreditation (CoA) Chair, Stephen Sonstein Program Curriculum & Courses
CoAPCR Mission The 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.