1 / 23

Guidelines for Clinical Trials in Uganda

Guidelines for Clinical Trials in Uganda. Jasper Ogwal-Okeng Gulu University Research Workshop 3 rd -6 th March 08. Clinical Trials. Evaluation of a Product for Clinical Effects Safety and Effectiveness Product can be Drugs Vaccines. Phases of Clinical Trials.

niyati
Download Presentation

Guidelines for Clinical Trials in Uganda

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Guidelines for Clinical Trials in Uganda Jasper Ogwal-Okeng Gulu University Research Workshop 3rd-6th March 08

  2. Clinical Trials • Evaluation of a Product for Clinical Effects • Safety and Effectiveness • Product can be • Drugs • Vaccines

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Procedure for Application submission • To Executive Secretary/Registrar NDA • Fee and structure • Clinical Trial application form • Documents accompanying application form (Appendices 1-17)

  11. FEE/STRUCTURE

  12. 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

  13. 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

  14. Amendments to Trial Protocol • May be partial or complete. • Urgent-Change and inform IRB, NCST,NDA • Otherwise resubmit to NDA and wait decision

  15. Inspection/Audit by NDA • To verify monitoring and audit of protocol • Facilities • Research staff • Compliance with protocol • Serious Adverse Events being reported

  16. Reports and Final Review • Reporting of Serious Adverse Events • Interim and Final Trial Reports • Dissemination and Publication • Archiving

  17. 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

  18. 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

  19. Application Procedures for CTL • Who to apply: • Principal Investigator • Sponsor (authorized person from a pharmaceutical company)

  20. 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

  21. HOW IT WAS - MAY 2004- GULU HOSPITAL

  22. HOW IT IS – OCTOBER 2004 - FACULTY OF MEDICINE

  23. Good Luck

More Related