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What is Good Clinical Practice? 3 FoU-centrum Skåne (R&D centre Skåne) Staben för forskning och...
Transcript of What is Good Clinical Practice? 3 FoU-centrum Skåne (R&D centre Skåne) Staben för forskning och...
2 2014-06-16
FoU-centrum Skåne
(R&D centre Skåne)
Support, information and education to scientists to improve the quality of clinical trials.
Preparation of applications to the authorities
Quality control of clinical trials
GCP education
Project management
Statistical support
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FoU-centrum Skåne
(R&D centre Skåne)
Staben för forskning och utbildning
Clinical study support: 4 clinical study managers
Medical statistics and epidemiology:
7 statisticians
Phase one unit: 10 study nurses and physician
BIG 3
READi
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The very first clinical trial
In 1747, James Lind, a British naval surgeon on the ship
Salisbury, performed a study of treatments for scurvy
(deficiency of vitamin C).
Twelve crew members were selected to receive one of six
treatments: cider, elixir of vitriol, vinegar, sea water, a
mixture of mustard, garlic and horseradish, and the last
group was given citrus fruits.
After 10 days the two men in the citrus group were almost
recovered. One returned to duty , the other one helped
nursing the others…
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Why clinical trials?
• Effective tool to investigate therapy, diagnosis
och prophylaxis
• Randomised – double blind – controlled (highest
level of evidence)
• The goal is to identify new standards of therapy
in a well-defined, limited population to benefit
the larger population
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Why Good Clinical Practice?
• International standard accepted worldwide
• A way to ensure that data generated by a clinical
trial are accurate, verifiable and reproducible
• Compliance with GCP provides public assurance
that the rights, safety, well-being, and
confideniality of trial participants are protected.
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Background to guidelines and
regulations
• The Jewish Chronic Disease Hospital Case
1963
• The Tuskegee Syphilis study 1932-1972. The
Belmont report
• Vipeholm study 1945-1951. ”Lördagsgodis”
• Thalidomide, late 1950s, teratogenicity
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Ethical background
Nürnberg code, 1947
Helsinki declaration WMA 1964, 1975, 1983, 1989,
1996, 2000, 2002, 2007, 2008, Fortaleza 2013
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ICH Guideline for
Good Clinical Practice
ICH-GCP is an international ethical and scientific
standard for designing, conducting, recording and
reporting clinical trials
CPMP/ICH/135/95, 17 January 1997
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GCP
Läkemedelslag
Läkemedelsförordningen
Patientdatalag
Offentlighets-och Sekretesslag
Patientskadelag
Datalag
Arkivlag
Arkivförordning
Personuppgiftslag
Personuppgiftsförordning
LV föreskrifter och allmänna råd om klinisk läkemedelsprövning
LVFS 1996:17
LV föreskrifter och allmänna råd om klinisk prövning av läkemedel för humant bruk
LVFS 2011:19
ICH guidelines for GCP
Declaration of Helsinki
Directive 2001/20/EC, 2005/28/EGImplementation of GCP
Detailed guidance-Adverse reactions reports-Eudravigilance database-EUDRACT database-Application Ethics Committe-Application authorities
Biobankslag
Etikprövningslag
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Helsinki declaration
”It is the duty of the physician to promote and
safeguard the health, well-being and rights of the
patients, including those who are involved in
medical research.”
”While the primary purpose of medical research is
to generate new knowledge, this goal can never
take precedence over the rights and interests of
individual research subjects.”
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Competence
• Competent and appropriately qualified
physician/other health care professional
• Ethics and scientific education and training
• Assessment of risks, burdens and benefits
• Adequate resources
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Safeguard the patients’ integrity,
rights and safety
• Adequate information about aim, method, risks,
discomfort and benefits
• Right to refuse participation, right to withdraw
consent at any time
• Freely given written informed consent
• Protect the confidentiality of personal information
• The risks must be monitored, managed and
documented.
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Scientific requirements
• Thorough knowledge of the scientific literature,
other relevant sources of information, and
adequate laboratory and, as appropriate, animal
experimentation
• Design and performance clearly described in a
research protocol
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Ethics committee approval,
registration and publication
• Approval of research protocol by an independent
research ethics committee before study start
• Every research study must be registered in a
publicly accessible database before recruitment
of the first subject
• The study results, positive as well as negative,
must be published or otherwise made publicly
avaliable.
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Introduction to ICH GCP
This guideline should be followed when generating
clinical trial data that are intended to be submitted
to regulatory authorities.
May also be applied to other clinical investigations
that may have an impact on the safety and well-
being of human subjects.
ICH GCP are based on the principles of the
Helsinki declaration.
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Clear, detailed study protocol –
a ”manual”
• Risk/benefit evaluation
• The rights, safety, and well-being of the trial
subjects are the most important considerations
• Adequate non-clinical and clinical information on
the study product to support the proposed
clinical study
• Statistical considerations, sample size
• Study protocol approved by the authorities
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Qualified physician and staff
• Physician and other staff should be qualified by
education, training and experience
• GCP training - mandatory
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The patient’s right, safety and
confidentiality should be protected
• Freely given informed consent prior to trial
participation.
• Documentation in medical records.
• Confidentiality of personal data records.
Identification replaced by a code in study
documents and database.
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During the study
• Effect and safety must be followed and
documented according to the protocol
• Serious side effects related to the study drug
must be reported to the European database
• Essential documents should be kept updated
• Quality control (monitoring) and quality
assurance
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Essential documents
Permit evaluation of the conduct of the study and
the quality of data – during the study and after.
Can assist in the successful management
Protocol, patient information, applications and
approvals, delegation list, CV, case record forms,
patient identification list, various instructions…
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Quality control
Verify
Rights and wellbeing of the patients are
protected
Trial data are correct and complete
The conduct of the study is in compliance
with the approved protocol, GCP and
regulatory requirements.