What is clinical research?

‘
CLINICAL’ means: ‘Treatment of patients’
‘
RESEARCH’ means: ‘Systematic investigation
& study in order to establish facts & reach new
conclusions’
•
A clinical trial (also clinical research) is a research
study in human volunteers to answer specific health
questions.
•
Carefully conducted clinical trials are the safest and
fastest way to find treatments that work in people
and ways to improve health.
•
Clinical trials are the final step in a long research
process that include preliminary laboratory research
and experiment.
Types of clinical trial
•
Interventional trials determine whether
experimental treatments or new ways of
using known therapies are safe and
effective under controlled environments.
•
Observational trials address health issues in
large groups of people or populations in
natural settings.
Phases of drug development
•
Identification of new molecule
•
Screening of biological activity/experiment
design
•
Preformulation
•
Formulation
•
Stability testing.
Phases of Drug Development
Steps prior to human trials:
•
Preclinical (nonclinical).

Animal and in vitro studies.
•
A study to test a drug procedure or other medical
treatment in animals. Preclinical studies are required
before clinical trials can be started.
•
Investigational new drug application (IND) or
Investigational device exemption (IDE) for the FDA
Basis for phased drug development
•
Safety
•
Pharmacology
•
Efficacy
Phases of Drug Development
Phase 1:
–
First studies in human.
–
Usually involve small groups of healthy volunteers or
Patients with particular disease – 20 - 80.
–
Short duration.
–
Provide preliminary safety and tolerability evaluation.
–
Establish pharmacokinetic and pharmacodynamic
profiles of the drug
Phases of Drug Development
–
Evaluate efficacy and short-term safety of the drug.
–
small groups of patients with disease under study.
–
100-300 subjects
–
Have well defined eligibility criteria
–
Determine dosing
–
Duration –couple of months to 2 years
Phase 2:
Phases of Drug Development
Phase 3
–
Larger, well-controlled trials with larger groups
of subjects.
–
Eligibility criteria usually broader
–
Simulate the actual treatment condition
–
Establishes safety and efficacy profile in broad
sample.
–
Results used in marketing application and official
product labeling.

Key CROs in India

Quintiles
Ahmadabad / Bangalore
Synchron
Ahmedabad /Bangalore
Lambda
Ahmedabad
Siro Clinpharm
Mumbai
I-Gate
Mumbai
Reliance Clinical Services
Mumbai
PPD
Mumbai
Onmnicare
Bangalore
ICON
Bangalore
Clin Trac
Bangalore
PharmaNet
Bangalore
Pharm-Olam
Bangalore
Lotus Labs
Bangalore
Vimta
Hyderabad
GVK
Hyderabad
BioServe Clinical Research
Hyderabad
Apothecaries
Delhi
Types of Jobs
•Clinical Monitors / CRAs
•Clinical Research Coordinators / Site Coordinators
•Drug Safety Personnel
•Project Personnel
•Medical Monitors
•Regulatory Affairs Monitors
•Medical Writers
•Quality Control / Assurance Personnel
•Data Management Personnel
•Statisticians
•Scientists
•Lab Personnel
•Management & Support Personnel
Types of Employers
•Pharmaceutical Companies
•Contract Research Organization
•Hospitals
•Non Government Organization
•WHO
Key cities in India for clinical
research
•Delhi &NCR Region
•Mumbai
•Pune
•Ahmedabad
•Hyderabad
•Bangalore
•Chennai
Challenges of current CR Industry
•
Major gap in Demand & Supply of trained
manpower – An unmet need
•By 2012 Indian market would be over US$2
billion, and would continue to grow at rapid pace.
•Over 75 CROs & 60 In-house Pharmaceutical
Clinical Research & R&D Facilities in India and
increasing
•Current trained manpower demand in the field of
Clinical Research is over 10,000 trained personnel
per annum.
•By 2012 over 50,000 certified/trained
professionals
will be required.
•The current facilities are able to train only
1,500 professionals.
•Employers required well trained professionals.
•Very rapid growth in number and size of
Company
•Lack of specialization
•Spectrum of skills required is in scarcity
•Limited pool of experienced people
•Employee retention
•Continuous training

ExlTech
Committed to provide highest
Quality training, education
&management solutions and develop
Superior human resource for the
Global clinical research industry