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 Testing InVitro and in Animals

• Toxicity
• Pharmacokinetics
• Possible useful

effects Filing of IND (Investigational New Drug)

Clinical Testing in Humans

• Phase I
• Subjects: Normal

Volunteers

• Tests: Metabolism

and Biologic Effects

• Phase II
• Subjects: Patients
• Tests: Therapeutic

Utility and Dose Range

• Phase III
• Subjects: Patients
• Tests: Safety and

Effectiveness

Filing of NDA (New Drug Application)

• Marketing Approval

Phase IV – Postmarketing Surveillance

Most common opportunities for clin linic ical l research professionals

Corporate/Private/Federal

• Clinical Research Monitors (CRA’s)
• Sponsors (Pharma/Biotech)
• CRO’s
• Data Managers
• Sponsors
• CRO’s
• Regulatory Affairs Professionals
• Corporate
• Central IRB’s
• FDA
• Post-Marketing Safety Surveillance
• Medical Writers

Academic Medical Centers/Private Research Sites

• Clinical Research Coordinators (CRC’s)
• Research Managers
• Subject Recruitment Specialists
• Data Managers
• Regulatory Affairs Professionals
• Academic IRB’s
• Technology Transfer offices

Evolution of Education/Training in Clinical Research

Act ctiv ivity

• Informal tr

train ainin ing: : coa

• achin

ing, tut tutorin ing

• Sh

Short

• rt ter

erm cou

• urses: ho

how w to

• do

do it! t!

• Prof
• fessio

ional l bo bodi dies (t (train aining, sup uppor

• rt)

Dis Discipli line

• Ac

Academic ic involv lvement: St Stan andards and and com

• mpetencie

ies

• Form
• rmal

l Curr Curric iculu lum: : sho hort and and lon

• ng

g ter erm pr prog

• grams
• Na

National ac accreditation and and ce certification

Profession

• Internatio

ional l St Stan andards/Harmoniz izatio ion of

• f Train

ainin ing/mutual l rec ecog

• gnit

itio ion

• Internatio

ional l Cert Certific ficatio ion/S /Specia iali lizatio ion

• Mai

Maintenance thr through gh CPD CPD

Evolution of Education/Training in Clinical Research

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 Practices,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