Transcript Guidelines for Clinical Trials in Uganda

Jasper Ogwal-Okeng
Gulu University Research Workshop 3rd-6th March 08
Clinical Trials
 Evaluation of a Product for Clinical Effects
 Safety and Effectiveness
 Product can be
 Drugs
 Vaccines
Phases of Clinical Trials
 Phase I: Healthy volunteers
 Phase IIa: Early phase II
 Phase IIb: Late phase II
 Phase III: RCT, blinded
 Phase IV: Pharmacovigilance
Phase I
 Follows successful pharmacological and toxicological
studies in animals
 Healthy volunteers
 Safety and pharmacokinetic data obtained (not
efficacy-since no symptoms)
 Start with 1/5th or 1/10th maximum tolerated dose in the
most sensitive animal species
 Placebo and double-blinded
Phase II Studies
 First administered to patients
 Phase II a (Early phase II)
 Potential benefits and side effects
 Establish dose range for phase IIb
 Phase IIb (Late phase II)
 Establish efficacy in specific disease
 Compare efficacy and side effects with other drugs for
same conditions
Phase III studies
 Randomized, controlled, double-blind ed
 Sufficient 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
Phase IV
 After drug obtained marketing license
 Monitored for
 Rare side effects
 Chronic toxicity e.g. cancer after many people- years of
use
 Previously unknown interactions
 Potential new therapeutic use
 Dose modifications
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
APPLICATION SUBMISSION,
REVIEW AND EVALUATION
 Procedures for submission
 Procedures for Review and Approval
 Institutional Review Boards
 Amendments to Trial Protocol
 Inspection/Audit by NDA
 Reports and Final Review
Procedure for Application
submission
 To Executive Secretary/Registrar NDA
 Fee and structure
 Clinical Trial application form
 Documents accompanying application form
(Appendices 1-17)
FEE/STRUCTURE
TYPE 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 US $ 4000
unknown product
Phase I, Phase II or Phase III patient /animal trial with a US $ 3000
known product
Phase IV trial
US $ 200
Protocol Amendment
TRIALS
OF
TRADITIONAL
MEDICINES
Traditional medicines
Complementary medicines
US $ 100
/COMPLEMENTARY
US $ 500
US $ 2000
Review and Approval of
Applications
 Completeness-form, document and fee
 Application reference number
 Supplementary Data and updates
 Expert Review (appointed by NDA)
 Approval by NDA’s Clinical Trials Committee (CTC)
 Approval communicated in writing
 Post Trial Review
Institutional Review Boards
 Established in the institution where research is done
 Ensures safety, integrity and human rights issues
 CTC of NDA oversees all IRBs
 NDA approves application after IRB and NCST
approvals
Amendments to Trial Protocol
 May be partial or complete.
 Urgent-Change and inform IRB, NCST,NDA
 Otherwise resubmit to NDA and wait decision
Inspection/Audit by NDA
 To verify monitoring and audit of protocol
 Facilities
 Research staff
 Compliance with protocol
 Serious Adverse Events being reported
Reports and Final Review
 Reporting of Serious Adverse Events
 Interim and Final Trial Reports
 Dissemination and Publication
 Archiving
CLINICAL TRIAL LICENSE (CTL)
 Approval for importation/manufacture of CT
commodities given after CT approval
 Products that require CTL
 Procedures for Application for CTL
 Conditions for CTL
 Importation and Release of Investigational Product (IP)
 Documentation for IP Release
Products that Require CTL
 Unregistered products, including placebos
 Registered
 Used/assembled in different form from approved form
 Used for unapproved indication
 Used to gain further information about approved use
 Local product manufactured for Clinical Trial
Application Procedures for CTL
 Who to apply:
 Principal Investigator
 Sponsor (authorized person from a pharmaceutical
company)
Attachments
 Format for Clinical Trial Protocol
 Investigator’s brochure
 Guide for labeling clinical trial medicines
 Letter of authorization
 Clinical Trial application form
 Format for clinical trial reports
 Declaration by Investigators
 Check list for required documentation
HOW IT WAS - MAY 2004- GULU HOSPITAL
HOW IT IS – OCTOBER 2004 - FACULTY OF MEDICINE
Good Luck