Good Clinical Practice - KSR

Good Clinical Practice (GCP)
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/

Introduction
• Clinical Research and Practice looks similar with
variation
– Research require to work in a stipulated frame work
– Where in the practice is patient oriented /beneficial
– The research do not require any clinical experience
and it starts with a research question
– but clinical practice do require clinical experience and
regularity
– To prevent undo practices in Clinical research and
practice “Good Clinical Practice” is brought out
1

Clinical Research
• Research is –
– A search for knowledge with Systematic
investigation to establish facts in scientific
manner
• Clinical Research is –
– Fact establishment in a clinic /hospital
depending on direct observation of patients
2

What is Clinical trial
• A clinical trial is a prospective evaluating
the effect and value of intervention (s) in
human beings under pre-specified
conditions
• A controlled clinical trial is a clinical trial
comparing an intervention group against
controls
3

Good Clinical Practice
Good Clinical Practice (GCP) is defined as –
A ‘standard for the design, conduct,
performance, monitoring, auditing,
recording, analyses and reporting of
clinical trials that provides assurance that
- the data and reported results are
credible and accurate, and that
- the rights, integrity and confidentiality
of trial subjects are protected’
4

GCP principles summary (1)
• Patient
– Rights, safety & well being of subjects prevail over
interests of science and society
– Individuals involved in trial should be qualified by
education, training and experience to perform his/her
tasks
• Data
– Information recorded, handled and stored to allow
accurate reporting, interpretation and verification and
confidentiality of subjects’ records
5

GCP principles summary (2)
• Study
– Trials shall be scientifically sound and guided by
ethical principles in all their aspects
– Necessary procedures to secure the quality of every
aspect of the trial shall be complied with
– Available non-clinical and clinical information shall be
adequate to support the trial
– Conducted according to Helsinki Declaration (1996)
– Protocol shall provide inclusion and exclusion criteria,
monitoring and publication policy
– Investigator/sponsor shall consider all relevant
guidance
6

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects
• Adopted by the 18th WMA
General Assembly Helsinki,
Finland, June 1964 and
amended by the
• 29th WMA General Assembly,
Tokyo, Japan, October 1975
Venice, Italy, October 1983
• 41st WMA General Assembly,
Hong Kong, September 1989
Somerset West, Republic of
South Africa, October 1996
• 52nd WMA General Assembly,
Edinburgh, Scotland, October
2000
• Note of Clarification on
Paragraph 29 added by the
WMA General Assembly,
Washington 2002
7

Declaration of Helsinki
• Basic Principles
– Concern for the interests of the subjects must always
prevail over the interests of science and society.
– Research must conform to accepted scientific principles;
design appropriate and clear in experimental protocol.
– Research must be conducted by qualified persons.
– Research must have importance proportionate to inherent
risk (risks acceptable given the benefits to individuals)
– Safeguard subjects’ integrity & privacy.
– Present results accurately in publications
– Inform subjects of their right to withdraw. Obtain true
informed consent from the subject or legal guardian.
8
41st World Medical Assembly, Hong Kong, September 1989.

• Medical Research Combined with Clinical Care
(Clinical Research)
– In the treatment of the sick person, the physician must be free to
use a new diagnostic and therapeutic measure
– The potential benefits, hazards and discomfort of a new method
should be weighed against the advantages of the best current
diagnostic and therapeutic methods
– In any medical study, every patient should be assured
– The physician can combine medical research with professional
care
– If the physician considers it essential not to obtain informed
consent, the specific reasons for this
– proposal should be stated in the experimental protocol for
transmission to the independent committee (I.2).
9

• Non-Therapeutic Biomedical Research
Involving Human Subjects (Non-Clinical
Biomedical Research)
– it is the duty of the physician to remain the protector
of the life and health of that person, on whom
biomedical research is being carried out.
– The subjects should be volunteers --either healthy
persons, or patients for whom the experimental
design is not related to the patient's illness.
– The investigator or the investigating team should
discontinue the research, if in his/her or their
judgment it may, if continued, be harmful to the
individual.
10

Note of Clarification on Paragraph 29 added by the
WMA General Assembly, Washington 2002 on
Placebo controlled trial
• Extreme care must be taken in making use of a placebo
controlled trial and that in general this methodology
should only be used in the absence of existing proven
therapy. However, a placebo-controlled trial may be
ethically acceptable, even if proven therapy is available,
under the following circumstances:
– Where for compelling and scientifically sound methodological
reasons its use is necessary to determine the efficacy or safety
of a prophylactic, diagnostic or therapeutic method; or
– Where a prophylactic, diagnostic or therapeutic method is being
investigated for a minor condition and the patients who receive
placebo will not be subject to any additional risk of serious or
irreversible harm.
11

GCP compliance
• Who must comply with GCP?
– All individuals involved in any aspect of the trial must be suitably
‘qualified’ to be able to comply with GCP.
– Sponsors/CIs are responsible for ensuring that all staff are able
to comply with GCP.
• ICH GCP section 5.18.3 allows individual researchers to
assess the needs of their trial and apply GCP
appropriately
‘central monitoring in conjunction with procedures such as
investigators’ training and meetings and extensive
written guidance can assure appropriate conduct of the
trial in accordance with GCP.’ (On-site monitoring not
compulsory)
12

What counts as qualified?
According to GCP each individual involved in
conducting a trial ‘shall be qualified by
education, training, and experience to perform
his or her respective task (s)’ (GCP – principle 8)
• Education
• Training
• Experience
There is no GCP ‘qualification’
13

GCP qualifications
• Education
– Clinicians must be clinically qualified
– Statisticians must be qualified
– Managers must be appropriately educated
• Training
– Employer induction courses
– Industry courses
– E-learning (Institute of Clinical Research)
– Private courses (usually run by freelance consultant)
– Host institution courses
– Trial specific workshops
– Investigators meetings
• Experience
– Discovering what is required
– Doing the job (sometimes wrongly)
– Cascading information and knowledge through teams/units
– Conversation to other trial makers
14

Approvals and permissions
• Ethics committee approval
• Clinical Trials Authorisation
• R & D permission
• Sponsor approval
15

Informed consent
• Following the second world war and the Nuremberg trials,
the Nuremberg Code and Declaration of Helsinki was
agreed worldwide as a charter to protect people/patients
against human experimentation
– Up until 1995 USA, Japan and Europe worked to different
standards in the conduct of clinical trials
– 1995 ICH-GCP was implemented – a global standard
– 2001 EU Directive set out regulations for clinical trials of medicines
conducted within the EU
– 2004 (May) the UK implemented the Directive and the UK
Regulations became law
Informed consent – personal autonomy
‘…a competent individual should have the right to determine
those discretionary risks he/she is willing to accept for
whatever benefits he/she perceives may result.’
16

Consent procedures
• Given freely
• Face to face
• Telephone
• Watch
• Listen
• Learn
• What works well?
• Share
17

Good Clinical Practice (E6)
• The GCP document describes the
responsibilities and expectations of all
participants in the conduct of clinical trials,
including investigators, monitors and sponsors.
• GCP covers the aspects of monitoring, reporting
and archiving of clinical trials and incorporating
addenda on the essential documents and on the
investigators broacher which had been agreed
earlier through consent process.
18

Good Clinical Practice (GCP) 19

• Phase 1
– First use in humans (healthy or ill)
– Physiological observations (pre-clinical status)
– Tolerance of different dosages
– Finding optimal dose-relationship
– Interactions with other treatments
– Pre-finding of clinical indication
• Phase 2
– Dose-relationship in patients
– Treatment efficacy compared to an other method or
substance
– Tolerance proof of dose (s)
– Physiological observations of phase I results
– Real finding of indication
22

• Phase 3
– Treatment efficacy compared to another method or
substance
– Give reasons for effect (power, number of cases)
– Tolerance proof of dose (s)
– Physiological observations of phase I&II results
– Confirmation interactions to be registered
• Phase 4
– Additional findings under conditions of daily use
– Periodic safety update to keep marketing
authorization (Vigoxx©, Lipoxx©)
– Impressions about new indication (s)
23

Designs of study
• Randomized clinical trial
• Parallel group design
• Crossover design
• Multi center studies (trials)
• Active control trial
– Superiority trial (new advances)
– Equivalence or non inferiority trial (safety
purpose)
24

Principles of Research
• Randomization principle
• Blindness principle
– Single / Double
• Placebo principle
• Intent to treat principle
25

Follow -
• CONSORT checklist
• Show proper reporting effects
– Acknowledgements
– Statistics
27

Acknowledgements
• GCP - J. Hedderich - Institut für Medizinische
Informatik und Statistik
• UKTMN
• MRC GUIDELINES FOR GOOD CLINICAL
PRACTICE IN CLINICAL TRIALS, March 1998,
Medical Research Council, 20, Park Crescent,
London, W1N 4AL
28

Good Clinical Practice - KSR

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