research
What is clinical research?
Commercialization
When do we need clinical
trials?
new drugs
,medical devices,
Reasons?
------may be they did not get symptomatic
relief???
Clinical trial –2
trial well designed,organised and conducted
definite outcome.
Results-conclusive.
Scope of clinical research?
Total cost of the drug development
900 million US $
Theconcept of randomised
controlled clinical trials appeared.
Further growth in ethical
issues
Institutional
review board/Institutional
ethics committee
Pharma companies
Clinical/contract research
organisations(CROs)
Biotech companies
Central diagnostic laboratories
Clinical research training institutes
Understanding clinical
research
New drug development
Clinical trials
NEW DRUG DEVELOPMENT
PROCESS
Drug discovery
Synthesis
Drug designing
Target validation(Preliminary in-vitro
screening)
Pharmacological assays
NEW DRUG DEVELOPMENT
PROCESS
Drug development
Safety
Efficacy
Kinetics
Formulation
PRECLINICAL STUDIES
.
Toxicity studies
Acute toxicity studies LD50
Sub- acute toxicity studies
Chronic toxicity studies
Special toxicity studies-
carcinogenecity,teratogenecity
genotoxicity,
effects on fertility and reproduction
PRECLINICAL STUDIES
Efficacy studies
Principal investigator
Co-investigator
Who participates in the
trial?
Subjects
Patients
Ethical issues and
guidelines
International conference on
hormonisation(ICH)
Good clinical practice(GCP)
Independent ethics committee IEC
Institutional Review board IRB
Informed consent
Good clinical practice
Itis the international standard for
conducting the clinical trials which lays
down the standard for
Design,
Conduct
Monitoring
Termination
Analysis and Documentation.
Informed consent
Transferring
part of the activity of drug
development to any other independent
organisations (contractual research
organisations).
STANDARD OPERATING
PROCEDURES
Written
instructions to achieve
uniformity in the performance.
FRAUD
Medico-marketting literature.
SUMMARY
Clinical research is an integral part of drug
development
Unlike the past, today the process has
gained a unique position due to the
regulatory requirements and ethical
guidelines available globally..
Designing, conducting,monitoring,
appropriate quality assurance and data
management determine the success of the
clinical research.