ICH GCP -HISTORY CLINICAL TRIALS- TYPES , DOCUMENTATION

1. PHARMAC
OVIGILAN
CE &
CLINICAL
TRIALS
Made by
VISHAKHA YENARE

2. CLINICAL RESEARCH
– Clinical research is a branch of healthcare science that determines the safety
and effectiveness of medications, devices, diagnostic products and treatment
regimens intended for human use.
– There are 3 basic steps
 DRUG DISCOVERY
 PRECLINICAL TESTING
 CLINICAL TRIALS

3. ICH GCP
International Conference on Harmonization-
Good Clinical Practice
– document makes recommendations on information that should be included
in a core clinical study report of an individual study of any therapeutic, or
diagnostic agent conducted in human subjects.

4. HISTORY BEHIND THE ICH GCP
 Tuskegee Syphilis Study (1932-1972)
 Nazi Experiments (1933)
(Included 10 experiments)
Out come of Nazi experiment is
 Nuremberg Code (1947)
Principles of Nuremberg code
• Voluntary consent
• Anticipate scientific benefits

5. HISTORY BEHIND THE ICH
GCP
• Animal experiments first
• Protected from harm
• No intentional death or disability
• Subject free to stop
• Qualified investigator
• Investigator will stop if harm occurs

6. HISTORY BEHIND THE ICH
GCP
 Sulfanilamide Disaster (1937)
 Thalidomide Disaster (1962) (voluntary)
 Declaration of Helsinki (1964) (safety, efficacy,quality)
 Belmont Report (1976) (respect, benefit, justice)
 ICH 1990(US JAPAN EUROPE)(SAFETY, EFFICACY, WELL BEING, QUALITY)


7. ICH GCP Principles
 Ethics
 Trial risk vs trial benefit
 Good quality trials
 Compliance with the study protocol
 Trial staff
 Informed consent
 Clinical trial data

8. ICH GCP Principles
 Confidentiality
 Quality assurance
 Good Manufacturing Practice
 Medical decisions
 Trial participants
 Information on the Medicinal Product

9. Structure of ICH
Quality Q1 Q12
Multidispilinary M1-M7
Safety S1-S11
Eficacy E1-E18
E2a-E2f pharmacovigilance
E6 Good clinical practises

10. Drug Development Process

11. CLINICAL TRALS

12. CLINICAL TRIALS
– Phase 0 MICRO DOSING (USFDA)
10-15
– PHASE 1 HUMAN EXPERIMENTAION TRIAL
Healthy 20-100
– PHASE 2 THERAPEUTIC EXPLORATORY TRIAL
Up to 300- 500
– PHASE 3 THERAPEUTIC CONFIRMATORY TRIAL
500-1000
– PHASE 4 POST MARKETIG SURVILANCE STUDY

13. PHARMACOVIGILANCE
Basically it is
 C ---COLLECTION
 A---- ASSISMENT
 R-----RECORD
 R -----REPORTINg
Of serious adverse event / adverse reaction

14. Aims of PV
 improve patient care and safety
 improve public health and safety
 the safe, rational and more effective (including cost-
effective) use of medicines
 promote education and clinical trials
 effective communication to the public.

15. Regulatory bodies in
INDIA
CDSCO
The Central Drugs Standard Control Organization
(CDSCO)under Directorate General of Health Services
,Ministry of Health & Family Welfare , Government
of INDIA
Head of CDSCO is DRUG CONTROLLER GENERAL OF INDIA
(DCGI) Dr. V.G. Somani

16. FUNCTIONS OF CDSCO

17. The New drugs and Clinical
trials rules 2019
– New rule on 19th March March 2019 by Government of India.
– Schedule Y is replaced by this 2019 guidelines.
– There are 3 schedules.
– Third schedule Conduct of CT
– Seventh schedule Formula to determine the quantum of compensation
in the cases of CT-related injury or death
– Eighth schedule Forms for application and issuance of permissions

18. ICMR
Indian Council of Medical Research
– The the apex body in India
– for the formulation,coordination and promotion
of biomedical research
– The ICMR is funded by the Government of India through the
Department of Health Research, Ministry of Health and
Family Welfare.
– In 2007 the organization established the Clinical Trials Registry
- India, which is India's national registry for clinical trials.
–

20.  Observational study: The aim is to study the relationship between a
characteristic and event without manipulating the conditions under which it
is studied.
 Experimental study: The researchers control the condition under which the
study is performed

21. The clinical trial design
– can be categorized into 5 groups
– Treatment trials: test experimental treatments, new combinations of drugs,
or new approaches to surgery or radiation therapy.
– Prevention trials: look for better ways to prevent disease in people who have
never had the disease or to prevent a disease from returning. These
approaches may include medicines, vitamins, vaccines, minerals, or lifestyle
changes.

23. The clinical trial design
– Diagnostic trials: conducted to find better tests or procedures for
diagnosing a particular disease or condition.
– Screening trials: test the best way to detect certain diseases or health
conditions.
– Quality of Life: trials (or Supportive Care trials) explore ways to improve
comfort and the quality of life for individuals with a chronic illness.
a fundamental objective of design is to ensure absence of any bias.

24. Study design
• Randomization
• Blinding
• Control arm. Following control is needed to have
comparison of test drug with other;
A- Active control/standard marketed drug
B- Placebo control

25. Study design
 Randomization
– Randomization or random allocation is a method of
dividing subjects into groups into such a way that the
characteristics of the subjects does not effect the group to
which they are allocated.
– It assures comparability of test groups
– It minimizes the possibility of selection bias

26. Study design
BLINDING
 The term blinding refers to the lack of knowledge of the
identity of the treatment administered.
 Types of blinding
 Single blind
 Double Blind
 Triple blind

27. TYPES OF BLINDING

29. REQUIREED FOR CT
PEOPLE INVOLVED IN THE STUDY
 Sponsor
(Project Manager; Study Monitor ;Study Coordinator)
 CRO
 Investigator Subjects / Volunteers
 Ethics Committee
 Biostatistician / Data Manager
 Regulatory Authority

30. Essential documents
• Trial Protocol with identifiable date and version
• Informed consent form with translations and back
translations
• Case Record Forms
• Brochures- Investigators and Patients
• Patient recruitment aids