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Knowledge Update Clinical documentation: from preclinical studies to drug registration

Knowledge Update Clinical documentation: from preclinical studies to drug registration. Split, 12 September 2008. Clinical programme. Registration. Drug discovery. Preclinical development. Company. Regulatory Agency FDA (US) EMEA (EU). Overview of drug development.

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Knowledge Update Clinical documentation: from preclinical studies to drug registration

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  1. Knowledge UpdateClinical documentation:from preclinical studies to drug registration Split, 12 September 2008

  2. Clinicalprogramme Registration Drug discovery Preclinicaldevelopment Company Regulatory AgencyFDA (US) EMEA (EU) Overview of drug development

  3. Phases of clinical development • Phase I • Initial evaluation of safety (max, 50 subjects), initial PK evaluation • Phase 2 • Preliminary evidence of activity (max 100 patients, important for planning phase 3) • Phase 3 • Establish efficacy (100+ patients)

  4. Clinical study report Synthesis+ Generalization Synopsis [Report] Summary tables Individual data Patient listings Clinical documentation is hierarchical

  5. Clinical documentation follows extensive and detailed guidelines ICH (International Conference on Harmonization) www.ich.org Aim: To “harmonise” interpretation and application of technical guidelines in the three main ICH regions (US, EU and Japan) for product registration. This should reduce or obviate the need to repeat trials/experiments during development of new medicines. Thus, more economical use of human, animal and material resources can be made while safeguarding quality, safety and efficacy.

  6. ICH guidelines Main page menu: Guidelines >> Note, “safety” does not refer to clinical safety; that comes under “efficacy”

  7. “Efficacy” guidelines

  8. Actual documents in clinical trials… • Investigator’s brochure • A manual distributed to each investigator with information on the drug in development, including detailed treatment of safety issues. • Protocol (later) • Clinical study report (later)

  9. Clinical trial protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. A clinical trial should not only comply with documentation requirements of ICH as regards content, but also with Good Clinical Practice (GCP). Ensure safety and rights of participants, define roles and responsibilities of those involved

  10. More detailed look at contents of a protocol • BACKGROUND AND RATIONALE • STUDY OBJECTIVES • INVESTIGATIONAL PLANIncludes overall study design, the study population (inclusion and exclusion criteria), the study medication, treatment assignment, efficacy evaluation, safety evaluation. • SAFETY DEFINITIONS AND REPORTING REQUIREMENTSDefinitions of adverse events • STATISTICAL METHODOLOGY AND ANALYSESShould be predefined (Statistical Analysis Plan [SAP]) • REFERENCES • PROCEDURES AND GOOD CLINICAL PRACTICEData management, ethics, Institutional Review Boards/Independent Ethics Committee, informed consent

  11. Reporting adverse events (AEs) MedDRA (Medical Dictionary for Regulatory Activities) Hierarchy • System organ class (SOC) [e.g. ‘Cardiac disorders’] • High-Level Group Terms (HLGT) • High-Level Terms (HLT) • Preferred Terms (PT) [e.g. ‘Supraventricular extrasystoles’] • Lower-Level Terms (LLT) Ensures Unification e.g. “blocked nose”/”congested nose”  “nasal congestion” Severity (severe, moderate, mild)/serious Causality (definitely, possibly, probably, unlikely, unrelated)

  12. Clinical study reports Guidelines  Actual TOC 

  13. Summary tables Administrativedocumentation Individual patient data The base of a clinical study report

  14. The body of a report Synopsis “Front end”(administrative + rationale+ methods) Results Discussion Refs/tables/ appendices

  15. Submission – the Common Technical Document (CTD) Discussion of the data (e.g. risk-benefit) Summary of those reports Individual study reports

  16. EU institutionsCommission / Parliament EMEA – Secretariat (mainly administrative tasks) Several committees,including… Pediatric Committee Committee for Human Medicinal Products (CHMP) Committee for Orphan Medicinal Products Working parties (WPs)Efficacy, safety, pharmacovigilance, etc Scientific advisory groupsOncology, diabetes and endocrinology, HIV/viral disease The regulatory agencies

  17. Useful info on the EMEA website (www.emea.europa.eu) EPARs (European Public Assessment Report) Human medicines (top menu) >> EPARs (side menu) << A-Z Listing of EPAR

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