Transcript Powerpoint Presentation - PharmAdvices

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CERTIFICATION OF INVESTIGATORS
CERTIFICATION OF
(CLINICAL) INVESTIGATORS
Prof. JanHasker G. Jonkman,
Ph.D., F.C.P., F.R.Q.A., R.Ph.,
Clinical Pharmacologist
University of Groningen (NL)
Professor Quality Management in Drug Research and Manufacturing
Stichting Certificering Klinisch Wetenschappelijk Onderzoeker
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CERTIFICATION OF INVESTIGATORS
CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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CERTIFICATION OF INVESTIGATORS
CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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GENERAL (1)
Definition:
• Certification is the official proof - in writing
and confirmed by signature - of the presence
of knowledge and the ability to perform
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GENERAL (2)
A high quality clinical study has to be performed
in accordance with:
• Appropriate ethical standards
• Appropriate medical standards
• Appropriate scientific standards
• Appropriate legal standards
• Appropriate regulatory standards
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GENERAL (3)
High quality clinical study data require Investigators with:
• Superior medical professional knowledge and skills
for the safe conduct of a clinical study
• Solid knowledge of Good Research Practices for
an ethical conduct of a clinical study
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GENERAL (4)
Are required knowledge and skills present? (1)
• Investigators sign Form 1572 (FDA) declaring that
they are qualified to conduct
and
are fully responsible for all aspects of the clinical study
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GENERAL (5)
Are required knowledge and skills present? (2)
• There is examination of medical knowledge and
professional skills
but
• There is no examination of knowledge and skills on
clinical research (‘Good Research Practices’)
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GENERAL (6)
‘These are the issues clinical trial sites are
struggling with based on my inspections.
But number one on the list is lack of GCP
knowledge and training’
Mike M. Rashti,
Food and Drug Administration, FDA, USA, 2006
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GENERAL (7)
‘The single most important step we could take
to improve clinical trials….. is to make sure that
those doing the research are qualified to do it’
Greg Koski,
Former Director of Office of Human
Research Protections, OHRP, USA, 2004
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GENERAL (8)
‘Heute ist die Durchführung Klinischer Prüfungen
ohne Spezialkenntnisse gar nicht denkbar’
Dr. Med. Norbert Clemens,
Bundesvorsitzender der Deutschen Gesellschaft
für Pharmazeutische Medizin e.V.
(DG PharMed, 2007)
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Source: The CenterWatch Monthly, November 2006
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Source: The CenterWatch Monthly, November 2006
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Source: The CenterWatch Monthly, November 2006
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GENERAL (9)
Training - The Netherlands
• University Groningen (+ University Utrecht)
GUIDE - Course ‘Good Research Practices GCP/GLP’
(since 1993)
Post graduate course
also open to external professionals
• Several commercial (in-house) courses
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Source: Good Clinical Practice Journal, September 2004, p19-22
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GENERAL (10)
Definition:
• Certification is the official proof - in writing
and confirmed by signature - of the presence
of knowledge and the ability to perform
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GENERAL (11)
Reasons for Certification (1)
• May improve safety of subjects
• May improve quality data
• Conveys a commitment to clinical research
• Provides assurance to Sponsor, authorities,
Medical Ethics Committees, study participants
and editors of journals that investigator understands
requirements of GCP etc.
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GENERAL (12)
Reasons for Certification (2)
• (Together with training): intellectual stimulation /
professional development
• Business advantage (for ‘commercial’ Investigators)
(N.B. In The Netherlands the law requires that an investigator has a
certificate in order to be allowed to perform animal experiments; ‘Art. 9’)
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CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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HISTORY (1)
• USA
ACRP* (Association of Clinical Research Professionals)
1992: certification of Clinical Research Co-ordinations (CRCs)
1995: certification of Clinical Research Associates (CRAs)
2002: certification of Physician Investigators (PI)
approximately 14.000 people certified
* www.ACRPnet.org
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HISTORY (2)
• USA
DIA* (Drug Information Association)
2002: certification of Clinical Investigators
SOCRA** (Society of Clinical Research Associates)
1995: certification of Clinical Research Professionals
AAPP (American Academy of Pharmaceutical Physicians)
APPI (Academy of Pharmaceutical Physicians
and Investigators; until 2003: AAPP = American Academy
of Pharmaceutical Physicians)
2003: certification of Physician Investigators
* www.diahome.org
** www.SOCRA.org
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HISTORY (3)
• USA
• 2006:
Certification programs of DIA and APPI have been
consolidated with ACRP programme resulting in two
new affiliates of ACRP:
Academy of Clinical Research Professionals
(The Academy) for certification of non-physicians
(CCRA = Certified Clinical Research Associate;
CCRC = Certified Clinical Research Coordinator)
APPI for certification of physicians
(CPI = Certified Physician Investigator)
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HISTORY (4)
• USA
total number of certificates: approximately 17.500
of which physicians approximately 400
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HISTORY (5)
• Europe
ACRP
ECCRT (European Centre for Clinical Research Training)
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HISTORY (6)
• Germany
DG PharMed
• The Netherlands
GUIDE* Graduate School for Drug Exploration
Certificate ‘Good Research Practices GCP / GLP’
University of Groningen
• Belgium
PHARMED** Post-graduate programme in pharmacology
and pharmaceutical medicine (University Brussels)
* www.rug.nl/guide or www.pharmadvices.com
**ulb.ac.be/medicine/pharmedwww
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CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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PRESENT SITUATION: THE NETHERLANDS (1)
New initiative for e-learning / e-testing / certification GCP (1)
• 2004:
Prof.Dr. JanHasker G. Jonkman, University of Groningen
Drs. Bert Harenberg, MediaVision, Laren
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PRESENT SITUATION: THE NETHERLANDS (2)
New initiative for e-learning / e-testing / certification GCP (2)
• 2005:
other founding members (‘Initiating Group’)
Dr. Helena van den Dungen (Dutch GCP Inspectorate)
Dr. Herman Pieterse (GCP Consultant)
Cecilia Huisman (ACRP; NVRV)
Dr. Philip Salden (Nefarma)
Dr. Rudolf van Olden (NVFG)
Drs. Pieter Guelen (ACRON)
completion of a printed ‘proposal’ entitled
‘GCP - The necessity of GCP-examination in The Netherlands’
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PRESENT SITUATION: THE NETHERLANDS (3)
• 2006 (1):
verbal commitment CCMO (Dr. M. Kenter)
contacts with NFU (Nederlandse Federatie Universiteiten; UMCs)
intention for a cooperation to design an exam in line
with requirements of NFU (subject: ‘Wet en Regelgeving’)
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PRESENT SITUATION: THE NETHERLANDS (4)
• 2006 (2):
On November 09;
Stichting Certificering Klinisch Wetenschappelijk Onderzoeker
(Foundation for Certification of Clinical Researchers)
residence:
 Assen
board:
 Prof.Dr. J.H.G. Jonkman
 Prof.Dr. R.A. de Zeeuw
 Dr. R.W. van Olden
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PRESENT SITUATION: THE NETHERLANDS (5)
Stichting CKWO: Objectives
1. a. To improve the quality of clinical research
in The Netherlands as well as elsewhere
b. To perform all actions that will be necessary to reach
the above mentioned objective
2. a. To establish and maintain a system for certification
of clinical researchers
b. To establish a system for examination in order
to reach this objective of certification
3. The Foundation is a non-profit organization
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PRESENT SITUATION: THE NETHERLANDS (6)
• 2006 (3):
Start of Editiorial Board
prepare first three exams
extended with two members on behalf of the NFU
 Dr. Mieke Trip (AMC)
 Dr. A.J.M. Craen (UMCL)
 Dr. Rudolf van Olden was replaced by
Drs. Alexandra Smeur-van Andel
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PRESENT SITUATION: THE NETHERLANDS (7)
Concept of exam:
• ‘Learning by Testing’
• Each exam consists of different ‘test cases’
• A 3-minutes video of a ‘real life’ situation (during
a clinical study) followed by 3-5 multiple choice
questions (= ‘Testing’)
When the answer is wrong, the right answer will be
given by the computer (= ‘Learning’)
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PRESENT SITUATION: THE NETHERLANDS (8)
The system of examination will fulfil the following
requirements (1):
• Individual training (‘Learning by Testing’)
• Modular system with different test cases and different
small certificates (‘deelcertificaten’), together forming
the full certificate
• Flexible system: large freedom for candidate to
choose modules in own order
choose time and place of examination
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PRESENT SITUATION: THE NETHERLANDS (9)
The system of examination will fulfil the following
requirements (2):
• Test cases should be interesting and stimulating
(motivating)
• It should be able to test not only knowledge of rules
and laws, but in particular to test ‘GCP-mentality’
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PRESENT SITUATION: THE NETHERLANDS (10)
The system of examination will fulfil the following
requirements (3):
• 2007
June:
first ‘try-out’ of examination in University
Medical Center Amsterdam (AMC)
(with three different video’s / test cases)
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CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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FUTURE (1)
• Prepare a publicly available list of ‘Certified Clinical
Researchers’ (open to the public including all
stakeholders like: Sponsors, authorities, Medical Ethics
Committees, potential study participants, editors of
journals, etc.)
• Obtain acknowledgement of the certificate by the
authorities e.g.: comparable with title ‘Clinical
Pharmacologist’ that is recognized in the WMO
(‘Wet Medisch-Wetenschappelijk Onderzoek met
Mensen’; ‘Law on Medical Research in Human Subjects’)
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FUTURE (2)
• More extensive use of the facilities of the web for the
examination
• May be extension to other area of Clinical Research
rather than only Good Clinical Practices
• May be extension to web-based training in Good
Research Practices (‘e-learning’)
• Hopefully the certification contributes to further
appreciation of The Netherlands as ‘clinical trial country’
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CERTIFICATION OF (CLINICAL) INVESTIGATORS
TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions
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CONCLUSIONS (1)
• Solid training in clinical research is of paramount
importance
• There are many deficiencies in the knowledge of
several clinical researchers as far as ‘Good Research
Practices’ concerns
• The knowledge of the staff involved should be easily
recognized by other stakeholders (Sponsors, authorities,
Medical Ethics Committees, potential study participants,
editors of journals, etc.)
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CONCLUSIONS (2)
• All opportunities of ‘e-learning’ and ‘e-testing’
will be used for learning and examination
• Higher quality of clinical research staff will increase
the attractiveness of The Netherlands as clinical trial
country
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