Professional? Stephen A. Sonstein, PhD Director, Clinical Research - PowerPoint PPT Presentation

What is a Clinical Research Professional? Stephen A. Sonstein, PhD Director, Clinical Research Administration Eastern Michigan University Chair, Committee on Accreditation of Academic Programs in Clinical Research

The Bio iopharmaceutical Research and Develo lopment Process

Steps i in New Drug Development Preclinical Filing of IND Phase IV – Filing of NDA Clinical Testing in Testing InVitro (Investigational (New Drug Postmarketing Humans and in Animals New Drug) Application) Surveillance • Toxicity • Phase I • Marketing Approval • Pharmacokinetics • Subjects: Normal Volunteers • Possible useful effects • Tests: Metabolism and Biologic Effects • Phase II • Subjects: Patients • Tests: Therapeutic Utility and Dose Range • Phase III • Subjects: Patients • Tests: Safety and Effectiveness

Most common opportunities for clin linic ical l research professionals Corporate/Private/Federal Academic Medical Centers/Private Research Sites • Clinical Research Monitors (CRA’s) • Clinical Research Coordinators (CRC’s) • Sponsors (Pharma/Biotech) • Research Managers • CRO’s • Subject Recruitment Specialists • Data Managers • Sponsors • Data Managers • CRO’s • Regulatory Affairs Professionals • Regulatory Affairs Professionals • Academic IRB’s • Corporate • Technology Transfer offices • Central IRB’s • FDA • Post-Marketing Safety Surveillance • Medical Writers

Evolution of Education/Training in Clinical Research Evolution of Education/Training in Clinical Research • Informal tr train ainin ing: : coa oachin ing, tut tutorin ing • Sh Short ort ter erm cou ourses: ho how w to o do do it! t! Act ctiv ivity ort ) • Prof ofessio ional l bo bodi dies (t (train aining, sup uppor • Ac Academic ic involv lvement: St Stan andards and and com ompetencie ies • Form ormal l Curr Curric iculu lum: : sho hort and and lon ong g ter erm pr prog ograms Discipli Dis line • Na National ac accreditation and and ce certification • Internatio ional l St Stan andards/Harmoniz izatio ion of of Train ainin ing/mutual l rec ecog ognit itio ion • Internatio ional l Cert Certific ficatio ion/S /Specia iali lizatio ion Profession • Mai Maintenance thr through gh CPD CPD

JTF Competency Domains Sonstein, S.A., Seltzer, J., Li, R., Jones, C.T ., Silva, H., Daemen, E. (2014, June). Moving form compliance to competency: A harmonized core competency framework for the clinical research professional . Clinical Researcher . 28(3); 17-23 • Applied Clinical Trials . May 28, 2014 • Journal of Clinical Research Best Practice s,10(6); 1-12. • CenterWatch Whitepapers , June, 2014.

Professional Certification in Clinical Research • Association of Clinical Research Professionals • CCRC/CCRA • Requires 2 yrs experience or 1 yr and academic program • CPI • Requires doctorate plus 2 years experience • Society of Clinical Research Associates • CRP • Requires 2 yrs experience • National Board of Medical Examiners • Monitor/Associate/Coordinator • Academic degree plus 2 years experience • Investigator/Scientist • Graduate degree or enrolled plus 2 years experience

CoA Sponsor • Consortium of Academic Programs in Clinical Research • www.coapcr.org • Programs in US, Canada, Australia, UK • Other non-member programs in Europe, Asia and Middle East

Committee on Accreditation of Academic ic Programs in in Clin linic ical Research (CAAPCR) • CoA formed (September, 2014) • CAAHEP Liaison – Bernard Cohen • Standards and Guidelines approved by CAAHEP Board (March, 2017) • CoA Bylaws approved (March, 2017) • CoA incorporated as non-profit in Florida (March, 2017) • Accreditation Services available (September, 2017) • Self-study format approved • 6 academic institutions expressed interest in accreditation • 2 already submitted RAS forms