CLINICAL RESEARCH

THE FUTURE OF TOMMOROW

 CLINICAL RESEARCH

• It is collection of data for the purpose of study such as.

• The natural history of the patient.
• To identify the effect of treatment on various diseases.
• To determine various risk factors.
• To manufacture products , which promotes good health and
diseases free longevity.
 CLINICAL TRIAL
• Its objective is to determine the safety and
efficacy on human may be patient or non
patient on an pharmaceutical ingredient.
 DRUG DISCOVERY PROCESS
PHASE SUBJECT POPULATION DURATION PURPOSE

PHASE 1 20-100 Several month •Safety in humans

Healthy subjects •Determine safe dose range
•Identify side effects
•“what the body does to the
drug”

PHASE 2 Upto several hundreds Several month to 2 •Efficacy

100-400 year •Further safety evaluation
Healthy and Diseased
Population

PHASE3 Several hundred to One to four year •Confirm effectiveness

thousands •Monitor side effects
200-1500 •Comparison to conventional
Diseased Population treatment existing
 CLINICAL DATA MANAGEMENT
CDM refers to management of data capture &
data flow processes in conduct of a clinical
research.
It begins with design of data capture instrument
& data collection, continues with data QC
procedures to assure quality of all aspects of
process, & ends with database finalization
 DATA VALIDATION
• I t is a process of collection of activities to assure the accuracy and
comprehensiveness of data during the trial . It also represent what going
on in the trial.
 SERIOUS ADVERSE EVENT
• ANY UNTOWARD MEDICAL OCCURRENCE AT
ANY DOSE WHICH RESULTS IN DEATH,
HOSPITALISATION, DISABILITY, BIRTH DEFECT
OR LIFE THREATNING.
 ADVERE DRUG RSEACTION
• IT IS AN NOXIOUS OR UNINTENDED
RESPONSE OF DRUG MAY OR MAY NOT BE
RELATED TO THE DRUG USED IN THE HUMAN
OR TRIAL SUBJECT INVOLVED IN THE CLINICAL
TRIAL.
 PROCESS FLOW
• Protocol  CRF Design  database design 
database testing  data completion  data
imaging  data entry  data validation 
lock database  Quality evaluation  final
safety review  freeze database  un-blind
database  final analysis  write CSR
(clinical study report) regulatory submission