"CLINICAL RESEARCH AND ITS OPPORTUNITIES"

1. By
Gurjeet J
(BTECH Biotechnology)
CLINICAL RESEARCH AND CLINICAL DATA MANAGEMENT
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2. Clinical Research
Introduction
1. What is a clinical trial /
research
2. Participation in a clinical
trial
3. Need of clinical research
4.Study design
5.Types of clinical research
6.Phases of clinical trial
7.Process of clinical trial
8.Players in clinical trial
9.Clinical trial industry
10.Career prospects 2

3. Introduction
To make things easier,
we will use the word
“treatment” to refer to
any type of intervention.
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4. Carefully conducted clinical trials are performed in human
volunteers to provide answers to questions such as:
.
Does a
treatment work?
Does it work
better than
other
treatments?
Does it have
side effects?
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5. Clinical research is often conducted at academic
medical centers and affiliated research study
sites.
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6. 2. PARTICIPATION IN A CLINICAL
TRIAL
Inclusion and exclusion
criteria factors:
Age
Gender
The type and stage of a
disease
Previous treatment history
& medical condition.
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7. Why are clinical
trials(Research)
important?
Clinical trials aim to enhance
new or existing treatments and
diagnostic strategies.
3. Need of
Clinical
Research
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8. Clinical trials help to
develop new and better
treatments for patients.
Assessing efficacy and
safety of a new
treatment.
For this reason, new
treatments usually take
a lot of time before
becoming publicly
available.
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9. Study design :
•Randomized trial / non randomized
•Blinding
•Placebo controlled study
•Crossover designs
•Factorial designs
•Study population
( inclusion/exclusion criteria)
•Planned statistical analyses/data need
•Enrollment of subjects
•Interventions
•Follow up of subjects
•Data collection, data monitoring etc.
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10. OPEN LABEL STUDY
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11. BLIND, BLINDED
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12. DIFFERENT TYPES OF
CLINICAL TRIALS
Treatment trials
Preventional
trials
Diagnostic trials
Quality of life
trials
Screening
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13. Phases of Clinical Trial
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14. Phase 0
• Also called Human Micro-dosing studies.
• Gathers preliminary data Pharmacodynamics
and Pharmacokinetics.
• Gives no data on safety or efficacy.
• Small number of subjects (10-15).
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15. Phase I
• First stage of testing in human subjects (20-
100).
• Designed to assess the safety, tolerability, PK
and PD of drug.
• Dose ranging – Dose escalation.
• Kinds of Phase I
– SAD
– MAD
– Food effect
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16. Phase II
• Therapeutic Exploratory Trial. (100-300 Subjects).
• Efficacy in patients (primary objective)
• Safety issues (secondary objective)
• Optimum dose finding
• Phase II
– Phase IIA: Designed to assess dosing
requirements
– Phases IIB: Designed to study efficacy
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17. Phase III
• Therapeutic confirmatory trials. (300-3000 subjects).
• To establish efficacy of the drug against existing
therapy in larger number of patients, method of usage
etc.
• Subtypes
– Phase IIIA: To get sufficient and significant data.
– Phase IIIB: Allows patients to continue the
treatment, Label expansion, additional safety data.
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18. Phase IV
• Post Marketing Studies (PMS).
• Involves safety surveillance.
• Determine behavior of drug in real life
situations.
• Evaluate action of drug in a situation of
missed dosage or over dosage.

19. PROCESS OF CLINICAL RESEARCH
Preclinical Testing
IND Application
Clinical Testing – Phase I
Clinical Testing – Phase II
Clinical Testing – Phase III
New Drug Application
Phase IV
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20. Phase IV
• Post Marketing Studies (PMS).
• Involves safety surveillance.
• Determine behavior of drug in real life
situations.
• Evaluate action of drug in a situation of
missed dosage or over dosage.
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21. Players in Clinical Trial
Regulator
Sponsor
CRO
Regulatory
Personnel
CRA
Project
Manager
Medical
Director
Investigator/Sub-
Investigator
CRC
Subjects
IRB
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22. CLINICAL TRIAL INDUSTRY & CAREER PROSPECTS
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23. Why Career in Clinical Research?
•Fastest growing segment in the healthcare / pharmaceutical industry
• Excellent Opportunity to Develop Combination of Technical and
Management Skill Development
•Part of the Global Growth Opportunity
•Wider Job Horizon
•Rapidly Growing Opportunities… (internal and external)
•Higher Salaries
•Higher Job Satisfaction
•Continuous Training Opportunities
•Overseas Job Opportunities
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24. Leading Companies in Clinical Trial
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25. Leading Companies in Clinical Trial
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26. Careers in Clinical Research
Clinical Research Associate
Clinical Research investigator
Study Coordinator
Data manager
Biostatistician
Regulatory Affairs Manager
Clinical Trials Auditor
Clinical Project Manager
Clinical Research Manager
Business development Manger
Drug Safety Associate
Medical Writer
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27. Career Opportunities
“More than 50,000 professionals will be required in the field of Clinical
research in India alone.”
Source : Mckinsey Report
Thus science, pharmacy and medicine graduates can look forward to exciting and
rewarding career opportunities in clinical research.
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28. Clinical Trial Quotations
“India is an emerging market with growing number of entrepreneurs foraying into
research and healthcare. Indian government is creating an effective regulatory
framework. Protection of patents and IPR is now improving. India has a better
place than countries like China in the clinical trials field”, Dr Charles Pierce,
president Global Clinical Partners, Inc. USA, said
Source: Pharmabiz
“Indian contract research Organisations will have good chance to shine, Indian
CROs are competitive compared to western companies. There are several
advantages to global companies to outsource research service from us”Dr. Goutam
Das ,CEO, Syngene International Pvt.Ltd.
Source: Chronicle Pharmabiz
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29. Thank you for your kind attention!
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