About clinical trial,phases of clinical trial,ethics of clinical trial and role of pharmacist in clinical trial.

1. PRESENTATION ON CLINICAL TRIAL
Presenter:
Sandeep Karki
Bachelor in Pharmacy

2. INTRODUCTION
 Any investigation in human subjects intended to
discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any
adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism,
and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
2
Presentation
on
Clinical
Trial

3.  Clinical trials are conducted only when
 satisfactory information has been gathered on the
quality of the new drug
 health authority/ethics committee approval is
granted in the country
3
Presentation
on
Clinical
Trial

4. STEPS BEFORE CLINICAL TRIAL
 Need or Demand
 Concept or Idea
 Research and Study
 Pre Clinical Trial
 Satisfactory Result
 Ethical clearance
 Informed Consent
4
Presentation
on
Clinical
Trial

5. PHASES OF CLINICAL TRIAL
 Phase 0 (Micro Dosing)
 For cost cutting
 Subject :- 10 to 15
 Days :- 7 days
 Purpose :- pharmacokinetic and pharmacodynamic
5
Presentation
on
Clinical
Trial

6.  Phase 1 (safety phase)
 Subject :- 20 to 80
 Purpose :- Safety, tolerability and potentially
damage effect
6
Presentation
on
Clinical
Trial

7.  Phase 2 (Therapeutic exploration)
 Subject :- 100 to 500
 Purpose :- Efficacy and dose range
 NOTE :- first phase where the drug is given to the
diseased patient.
7
Presentation
on
Clinical
Trial

8.  Phase 3 (Therapeutic conformation)
 Subject :- 500 to 3000
 Purpose :- safety and tolerability
8
Presentation
on
Clinical
Trial

9.  Phase 4 (Post marketing phase )
 Conducted after the drug is consumed by the
patients
 Purpose :- safety, acceptability, ADR and off label
use.
9
Presentation
on
Clinical
Trial

10. 10
Presentation
on
Clinical
Trial

11. ETHICS OF CLINICAL TRIAL
 According to the ICH-GCP guidelines,all clinical trials should
be conducted in compliance with ethical standards, clear
scientific proof, and benefit overweigh risk; and a clear well-
documented protocol is required.
 Obtaining an informed consent and affirming confidentiality.
 The trial staff should receive adequate training along with their
appropriate qualifications.
 Data should be documented accurately and easily accessible
and available.
 Manufacturing the investigational products should be in
accordance with Good Manufacturing Practice (GMP)
guidelines.
11
Presentation
on
Clinical
Trial

12. ICH-GCP GUIDELINES
 Was issued by the International Conference for
Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) in
1996
 Representatives of regulatory bodies and pharmaceutical
companies from Japan, United States, European Union,
Australia, Canada, and Nordic Countries as well World
Health Organization (WHO) participated in the
development of these guidelines.
 In January1997, the guideline became effective and
implemented for clinical trials involving human subjects
12
Presentation
on
Clinical
Trial

13. CONTENT OF ICH-GCP GUIDELINES
1. Glossary
2. Principles
3. Ethics Committee
4. Investigator
5. Sponsor
6. Protocol
7. Investigators Brochure
8. Documentation
13
Presentation
on
Clinical
Trial

14. THE PRINCIPLES OF ICH GCP
 Clinical trials should be conducted in accordance with the ethical
principles.
 Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the
individual trial subject and society.
 The rights, safety, and well-being of the trial subjects are the
most important considerations
 The available nonclinical and clinical information on an
investigational product should be adequate to support the
proposed clinical trial.
 Clinical trials should be scientifically sound, and described in a
clear, detailed protocol.
 Each individual involved in conducting a trial should be
qualified by education, training, and experience to perform his or
her respective task(s).
 All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting, interpretation
and verification.
14
Presentation
on
Clinical
Trial

15. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
(IRB/IEC)
 An independent body (a review board or a committee,
institutional, regional, national, or supranational),
constituted of medical professionals and non-medical
members, whose responsibility it is to ensure the protection
of the rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of that
protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial
protocol, the suitability of the investigator(s), facilities, and
the methods and material to be used in obtaining and
documenting informed consent of the trial subjects
15
Presentation
on
Clinical
Trial

16. INVESTIGATOR
 A person responsible for the conduct of the clinical trial
at a trial site.
 If a trial is conducted by a team of individuals at a trial
site, the investigator is the responsible leader of the team
and may be called the principal investigator.
16
Presentation
on
Clinical
Trial

17. SPONSOR
 An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
17
Presentation
on
Clinical
Trial

18. PROTOCOL
 A document that describes the objective(s), design,
methodology, statistical considerations, and organization
of a trial.
 The protocol usually also gives the background and
rationale for the trial.
18
Presentation
on
Clinical
Trial

19. INVESTIGATOR'S BROCHURE
 A compilation of the clinical and nonclinical data on the
investigational product(s) which is relevant to the study of
the investigational product(s) in human subjects.
 Contents of the Investigator’s Brochure
• Table of Contents
• Summary
• Introduction
• Physical, Chemical, and Pharmaceutical Properties and Formulation
• Nonclinical Studies
• Effects in Humans
• Summary of Data and Guidance for the Investigator
19
Presentation
on
Clinical
Trial

20. DOCUMENTATION
 All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and
scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the
factors affecting a trial, and the actions taken.
20
Presentation
on
Clinical
Trial

21. ROLE OF PHARMACISTS
 Once the pharmacologist has demonstrated a new compound to be
effective and safe in animal test, clinical trials are invariably
commenced.
 These trials usually proceed in two steps-preliminary and extended.
 During the preliminary stage, the principal investigator cautiously
administers the drug to a limited number of selected patients and closely
follows the results.
 After having gained experience and confidence in its use, the
investigator is generally ready to conduct an extended comprehensive
evaluation of its efficacy.
 During this stage, the pharmacist can play an important role by assisting
in the development of the protocol and the control of a double blind
test/study—having the experimental drug and placebo prepared exactly
the same dosage form and presentation. Neither the patient nor the
doctor informed as to whether the placebo and the potent article.
21
Presentation
on
Clinical
Trial

22. CONT…
 To safeguard subjects, pharmacist can ensuring that investigated
drugs are appropriate for use and are procured, handled, stored and
used safely and correctly
 To ensure that investigated drugs are managed and dispensed to
patients in accordance with the protocol
 To ensure that all pharmacy clinical trial procedures comply with
relevant guidelines and regulations
 To ensure that the ID is in good condition for use, verify the drug
product packaging and labeling, pharmaceutical form, lot number,
manufacturing and expiration dates, the correct use, handling and
storing conditions
 To ensure that the ID is stored according to the room conditions
(temperature, light and humidity)
22
Presentation
on
Clinical
Trial

23. THANK YOU
23
Presentation
on
Clinical
Trial