description of phases 3 and 4 of ct

1. CLINICAL TRIAL PHASE 3 AND 4
BY
SANCHIT RASTOGI
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2. PHASE 3
• Also known as therapeutic confirmatory trials
• randomized controlled
• multicenter trials
• on large patient groups (300–3,000 or more depending
upon the disease/medical condition studied)
• Safety ,drug interactions are accessed on a larger scale
• Additional pharmacokinetic data may be obtained.
• Phase III trials are the most expensive
• time-consuming
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3. PHASE 3 (CONTINUES)
• difficult trials to design
• especially in therapies for chronic medical
conditions
• continue while the regulatory submission is
pending at the appropriate regulatory agency.
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4. PHASE 3 CONSIST OF TWO PARTS
PHASE 3A
• Trials carried out on a large number-or in a special
category – Regulatory requirement for NDA
PHASE 3B
• Extended trials of IIIa after applying for approval but
before launch.
• Phase 3b studies are known as "label expansion" (to show
the drug works for additional types of patients/diseases
beyond the original use for which the drug was approved for
marketing), to obtain additional safety data, or to support
marketing claims for the drug.
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5. New Drug Application (NDA)
• NDA filing process is applying for marketing
approval to regulatory body.
• Aplication contains often in hundreds of
volumes, full reports of all preclinical and
clinical data.
• Review and decision of approval may take 3
years or longer.
• Controlled marketing allowed for life
threatening diseases
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7. POST MARKETING
SURVEILLANCE
• Used to describe the research and studies
associated with product safety evaluation
after the drug has been approved for
marketing.
• Pms=Pharmacovigilance+Pharmacoecon
omics+Pharmacoepidemiology.
• No fix duration
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8. SOME DATES IN THE HISTORY OF
PHARMACOVIGILANCE
• 1848
The Lancet starts collecting notifications of side effects after a death caused
by anaesthesia
• 1906
US Federal Food and Drug Act requires that pharmaceuticals be “pure” and
“free of any contamination”
• 1937
USA: 107 lethal cases after diethylenglycol was mistakenly used to
solubilize sulphanilamides
• 1952
France: 100 lethal cases after diethyl tin diodide was mistakenly used in a
skin preparation
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9. CONTI……..
• 1959-61
Reports of foetal abnormalities in relation with the use of a new sleep-
inducing drug thalidomide (biggest number in Germany)
• 1962
USA revised law requiring to prove safety and efficacy before issuing
marketing authorisation
• 1964
UK starts “yellow cards” system
• 1967
WHO’s International Drug Monitoring Programme
• 1976
Drugging of the Americas: inadequacy of safety information
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10. OBJECTIVES OF PMS
Conform the efficacy and safety profile in large populations during
practice
Detect the unknown adverse drug reaction/s
Evaluation of over-dosage and treatments
Identifications of new indications
Evaluation of new formulations, dosages, durations of treatment
Evaluation in different age groups / types of patients
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11. PMS METHODOLOGIES
• Spontaneous reporting system
• Case reports
• Cross sectional studies
• Cohort studies
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12. SPONTANEOUS REPORTING SYSTEM
• Health care personal suspects that a particular
medication is associated with an adverse event
observed during the course of caring for a patient,
reports the ADE to a formal reporting system.
Various reporting systems are:
WHO INTERNATIONAL SYSTEM
USFDA –MEDWATCH
UK –YELLOW CARD SYSTEM
NATIONAL PHARMACOVIGILANCE SYSTEM
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13. WHO INTERNATIONAL SYSTEM
• Established in 1968
• Headquaters in geneva
• Who collaborating centre for international
drug monitoring-uppsala monitoring centrein
sweden
• Individual case reports of suspected adr are
collected and stored in a common database.
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Official member countries
Associate member countri
WHO Drug Monitoring Progra
Participating countries 1999

15. USFDA –MEDWATCH
• Allows health care professionals and
consumers to report serious adr that they
suspect are associated with the drugs and
medical devices they prescribe,dispense or
use.
• Reporting can be done on line, by phone, or
by submitting the medwatch 3500 form by
mail or fax
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16. UK –YELLOW CARD SYSTEM
• Came into existence in 1964
• States that “every member of the medical and
dental profession in the uk..” to
report ..”promptly the details of any untoward
condition in a patient which might be the
result of drug treatment.
• Example:halothane in jaundice
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18. NATIONAL PHARMACOVIGILANCE
SYSTEM
INDIA
• launched by CDSCO in november,2004
• Aim-to develop the culture of ADR notifications by heatlh
care workers country is divided into zone and regions
CDSCO, new delhi at the top followed by SETH GS
MEDICAL COLLEGE,MUMBAI AND AIIMS IN NEW
DELHI
• Then there are 5 regional centers i.e
KOLKATA.MUMBAI,NAGPUR,DELHI,PONDICHERRY
• 28 peripheral systems spread across the country
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19. COHORT STUDIES
• Groups of individuals are identified
• Followed over time to time to determine the
incidence of some predetermined outcome
• Generally is of two types:
• Prospective study
• Retrospective study
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20. CASE CONTROL STUDY
• Allow health care workers to share their
individual experiences in published medical
literature.
• Play important role in communicating
previously unidentified uses and dangers of
drug.
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21. CROSS SECTIONAL STUDIES
• It is an observational study in which drug
exposure and diseased status or symptoms
are determined at a single point in time
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22. COMPUTERS IN PMS
• Arisg
• Dsnavigator
• Oracle
• Argus assurance
• Expert direct
• sas
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“There are 3 actions of a drug:
the one we want , the one you
don’t want , and the one you
don’t know about”

25. FUTHER READING
• Edwards IR, Aronson Jk , adverse drug reactions:
definitions, diagnosis, and management. Lancet
2000:356:1255-9
• Goyal R.K, basics of hospital and clinical
pharmacy,1st
edition, B.S Shah publication,
Ahmadabad, pg 261 -277
• Tripathi KD,”essentials of medical
pharmacology”,jaypee brothers medical publishers,6th
edition,pg no.78-86
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QUESTIONS?
COMMENTS?

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THANK YOU