Transcript What is Pharmaceutical Medicine?

Going “Pro”
The Rise of Professionalism in
Clinical Research and
Pharmaceutical Medicine
Greg Koski, PhD, MD, CPI
Associate Professor of Anesthesia
Harvard Medical School
President Elect, Academy of Pharmaceutical Physicians &
Investigators and Trustee of the Association of Clinical Research
Professionals
Former Director, Office for Human Research Protections
U.S. Department and Health and Human Services
Clinical Research in Evolution
1974-1999
– Pre-Gelsinger Era
2000-2002
– Post-Gelsinger Crisis
– The Tipping Point: Johns Hopkins
2003-2006
– Transition for Translation
– The Cultural Imperative
2006-present
– The Professional Paradigm Emergence
“Someday, I’m
gonna be a
professional ”
Justice Louis Brandeis Described
Basic Elements of Professionalism:
“First, a profession is an occupation for which the
necessary preliminary training is intellectual in character,
involving knowledge and to some extent learning as
distinguished from mere skill;
Second, it is an occupation which is pursued largely
for others and not merely for one’s self;
Third, it is an occupation in which the amount of financial
return is not the accepted measure of success.”
Additional Elements
of a “ Profession”
Membership is limited to qualified
individuals
Standards for qualification are
established by the members
Standards based on competence, strive
for excellence
Behavior is self-regulated
Characteristics of Professionals
Altruism
Communication
Compassion
Scholarship
Responsibility
Knowledge
and Skills
Excellence
Respect
Accountability
Leadership
Honesty
Caring
Integrity
Adapted from the National Board of Medical Examiners
Professionalism in Medical Education
Before Flexner (1910)
– Proprietary Medical Schools
– No or Few Standards
After Flexner
–
–
–
–
Rise of Academic Medical School
Standards for Curriculum
Competency by Examination
Validation by Accreditation and Certification
Clinical Research Training Options
‘On the job’
Supervisor, mentor, SOPs
Self study (books, Internet)
Local medical meetings (ACRP, AAPP, medical
schools)
Sponsor monitoring, audits, inspections
Investigator Meetings
Technical Courses
Academe vs. Business
Conference vs. distance learning
Accredited vs. non accredited
Diplomas and degrees
MSc, PhD, Fellowships
Adapted from Hans de Han, AAPP
Proprietary Training Courses
AAPP
AMA
ACRP
Barnett International
Cambridge Healthtech Institute
Center for Business Intelligence
DIA
Institute for International Research
Parexel
Pharmaceutical Education & Research Institute (PERI)
Pharmaceutical Training Institute
PharmaTech
SOCRA
Uniteck
Certification of Clinical Research
Professionals
The Clinical Research Team
– Non-physicians
Clinical Research Associates
Clinical Research Coordinators
– IRB Professionals
– Regulatory Professionals and
Administrators
Evolution of Investigator Certification
Multiple Proprietary Providers
Unitary Proprietary Provider
Recognition
–
–
–
–
by the profession
by authorities
by sponsors
By the public
Independent Professional Board
Public Expectation
Proprietary Certification Eligibility
Criteria, circa 2005
APPI
Certified Physician Investigator (CPI)
Compliance with Regulations, Laws,
Statutes, Codes and Guidelines
Protection of Study Participants
Conduct of the Study
Managing the Study Site and
Organization
Ethics and Professional Conduct
Adapted from Hans de Han, AAPP
What is Pharmaceutical Medicine?
The medical discipline devoted to…
discovery, research & development…
supporting ethical promotion and safe use
of…
medical products (drugs, vaccines,
devices,
diagnostics, etc) to…
improve health and quality of life of
society
Pharmaceutical Medicine Curriculum
Drug discovery
Preclinical testing
(pharmacology,
toxicology,
pharmacokinetics, etc)
Pharmaceutical
development
Clinical Pharmacology
Clinical trial design
Medical statistics
Regulatory affairs,
medicolegal and ethic
issues
Market support, drug
labeling
Drug safety
monitoring,
pharmacovigilence
Pharmacoeconomics
Risk:benefit
assessment
Management and
Administration
Adapted from Hans de Han, AAPP
Pharmaceutical Medicine “Going
Pro”
American Board of Medical Specialties
Sub-Specialty
Board
American
Board of
Internal
Medicine
Sub-Specialty
Board
C
A
Q
Sub-Specialty
Board
Current Events
Where are we headed?
The TeGenero Disaster
Renegotiating the Grand Bargain
The Opportunities
– For Industry
– For Government(s)
– For Global Capacity Building
Thank You!
Please join me in acknowledging
the many unselfish individuals
who volunteer to participate in
clinical research for the benefit of
science and society, for without
them, there would be no clinical
research—they are the strongest
justification for professionalism in
clinical research.