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CLINICAL TRIALS – PHASE III
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What are phase III trials Confirmatory phase (Therapeutic
confirmatory trial) Trials are done to obtain sufficient
evidence about efficacy and safety Conducted in larger number of patients In comparison with standard
drug/placebo
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OBJECTIVES
To establish efficacy of the drug against existing therapy
To establish the safety in relatively large number of patients
To establish method usage in clinical practices
To identify contraindications, warnings
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SUB-TYPES
Phase III a
Before submission of NDA Phase III b After submission of NDA but
before approval
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STUDY- SITES Conducted at community
hospitals Other facilities Nursing home Private clinics Multicentric High costs involved
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AGREEMENTS
Agreements with investigator (time lines, responsibilities, financial support, archives, publication of results etc)
Agreements with laboratories (time lines, costs, quality)
Agreements with hospitals (for use of facilities and payments if any
Agreements with courier companies for shipments
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STUDY POPULATION
Patients with target disorder Patients for whom drug may be indicated Number of patient upon
Statistical requirement Availability of patients Regulatory requirements depends
Avoid patient with severe medical
conditions
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STUDY DESIGN Need of study design in phase
III Randomization Blinding Control Control is needed to have
comparison of test drug with other
A- Active control B- Placebo control
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CONTD…
Inclusion criteria is more flexible as large number of patients are recruited
COMPLIANCE Should noncompliant patients be
discontinued from study ?
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ESSENTIAL DOCUMENTS
Trial Protocol with identifiable date and version
Informed consent form with translations and back translations
Case Record Forms Brochures- Investigators and Patients Patient recruitment aids
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SITE PREPARATIONS
Ensure that IRB exists and functions as per regulatory requirements
Ensure personnel are adequately trained, both in technology and GCP
Collect all documents pertaining to the site eg. CVs of investigators Conflict of Interest Forms Training certificates if required
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TRIAL MANAGEMENT
Manage supply of trial related documents, trial supplies
Recruitments schedules and time lines Co-ordination with laboratories Timely receipt and completion of CRFs Resolution of queries Payment to sites
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PATIENT VISIT
Patient visits should be as per visit schedule
Match patient visits with logs Deviations are followed up Remedial action identified and
communicated Patient withdrawals- identify and remedy
the causes
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INITIATION MEETING
Held after all trial material reaches sites Held on site or by phone or video
conference Discuss all procedures again Confirm total understanding and
availability of trial material If all is clear declare site open for
recruitment
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Monitoring
To check/watch study To evaluate progress of trial To check compliance with SOPs, Protocol
and Regulatory requirements If any fault that should be brought in
notice of sponsor
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INVESTIGATORS MEETING
Held after all documents are complete To be attended by Investigator’s and co-
ordinators Discuss protocol, ICF administration, CRF
entry, randomization and recruitments, trial procedures, financial agreements and any study related activities
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AUDITING
To check compliance with protocol, SOP’s, and GCP
Observation and finding of auditor should be documented
Auditors may audit GMP conditions under which the drug was manufactured
Auditors may audit electronic systems for compliance with 21CFR 11.
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CLOSE OUT
After ensuring the study is complete. All CRF received All study material is accounted for All investigational product is accounted
for and balance returned to sponsor Ensure payment completion
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TIME PERIOD & FEE
Study generally lasts anywhere from 2 to 10 years (with an average length of 5years)
According to Sch. Y the fee required for Phase III is Rs.25000