Jasper Ogwal-Okeng Gulu University Research Workshop 3 rd -6 th March 08.
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Transcript of Jasper Ogwal-Okeng Gulu University Research Workshop 3 rd -6 th March 08.
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Jasper Ogwal-Okeng
Gulu University Research Workshop 3rd-6th March 08
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Clinical TrialsEvaluation of a Product for Clinical Effects
Safety and EffectivenessProduct can be
DrugsVaccines
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Phases of Clinical TrialsPhase I: Healthy volunteersPhase IIa: Early phase IIPhase IIb: Late phase IIPhase III: RCT, blindedPhase IV: Pharmacovigilance
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Phase IFollows successful pharmacological and
toxicological studies in animalsHealthy volunteersSafety and pharmacokinetic data obtained
(not efficacy-since no symptoms)Start with 1/5th or 1/10th maximum tolerated
dose in the most sensitive animal speciesPlacebo and double-blinded
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Phase II StudiesFirst administered to patients
Phase II a (Early phase II)Potential benefits and side effectsEstablish dose range for phase IIb
Phase IIb (Late phase II)Establish efficacy in specific diseaseCompare efficacy and side effects with other
drugs for same conditions
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Phase III studiesRandomized, controlled, double-blind edSufficient sample size for statistical
evaluation of efficacy and safety.Successful phase III trial leads to New Drug
Submission (NDS) NDS requests permission to market new drug
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Phase IVAfter drug obtained marketing licenseMonitored for
Rare side effectsChronic toxicity e.g. cancer after many people-
years of usePreviously unknown interactionsPotential new therapeutic useDose modifications
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Guidelines for Clinical Ttrials in Uganda
All medicines used in Uganda should be registered with National Drug Authority (NDA)
Written approval of NDA needed for clinical of drugs (registered/unregistered) used in Uganda
Guidelines gives procedures of application for clinical Trials
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APPLICATION SUBMISSION, REVIEW AND EVALUATIONProcedures for submissionProcedures for Review and ApprovalInstitutional Review BoardsAmendments to Trial ProtocolInspection/Audit by NDAReports and Final Review
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Procedure for Application submissionTo Executive Secretary/Registrar NDAFee and structureClinical Trial application formDocuments accompanying application form
(Appendices 1-17)
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FEE/STRUCTURETYPE OF TRIAL FEES
HUMAN AND VETERINARY TRIAL
Phase I Healthy Volunteer trial US $ 500
Phase I, Phase II or Phase III patient/animal trial with an unknown product
US $ 4000
Phase I, Phase II or Phase III patient /animal trial with a known product
US $ 3000
Phase IV trial US $ 200
Protocol Amendment US $ 100
TRIALS OF TRADITIONAL /COMPLEMENTARY MEDICINESTraditional medicines US $ 500
Complementary medicines US $ 2000
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Review and Approval of ApplicationsCompleteness-form, document and feeApplication reference numberSupplementary Data and updatesExpert Review (appointed by NDA)Approval by NDA’s Clinical Trials Committee
(CTC)Approval communicated in writingPost Trial Review
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Institutional Review BoardsEstablished in the institution where research
is doneEnsures safety, integrity and human rights
issuesCTC of NDA oversees all IRBsNDA approves application after IRB and
NCST approvals
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Amendments to Trial ProtocolMay be partial or complete.Urgent-Change and inform IRB, NCST,NDAOtherwise resubmit to NDA and wait decision
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Inspection/Audit by NDATo verify monitoring and audit of protocolFacilitiesResearch staffCompliance with protocolSerious Adverse Events being reported
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Reports and Final ReviewReporting of Serious Adverse EventsInterim and Final Trial ReportsDissemination and PublicationArchiving
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CLINICAL TRIAL LICENSE (CTL)Approval for importation/manufacture of CT
commodities given after CT approvalProducts that require CTLProcedures for Application for CTLConditions for CTLImportation and Release of Investigational
Product (IP)Documentation for IP Release
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Products that Require CTLUnregistered products, including placebosRegistered
Used/assembled in different form from approved form
Used for unapproved indicationUsed to gain further information about
approved useLocal product manufactured for Clinical Trial
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Application Procedures for CTLWho to apply:
Principal InvestigatorSponsor (authorized person from a
pharmaceutical company)
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AttachmentsFormat for Clinical Trial ProtocolInvestigator’s brochureGuide for labeling clinical trial medicinesLetter of authorizationClinical Trial application formFormat for clinical trial reportsDeclaration by InvestigatorsCheck list for required documentation
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HOW IT WAS - MAY 2004- GULU HOSPITAL
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HOW IT IS – OCTOBER 2004 - FACULTY OF MEDICINE
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