Implementation of MedDRA industry perspective

Transcription

1 Implementatin f MedDRA industry SFDA ICH MedDRA Wrkshp, Beijing, May 2011 Christina Winter, MD, FFPM Medical directr GlaxSmithKline R&D / ICH MedDRA Management Bard 2011 ICH Internatinal Cnference n Harmnisatin f Technical Requirements fr Registratin f Pharmaceuticals fr Human Use 2011 ICH 1

2 Disclaimer: The infrmatin within this presentatin is based n the presenter's expertise and experience, and represents the views f the presenter fr the purpses f a training wrkshp ICH 2

3 Intrductin Why is clinical cding needed? When is a clinical cding dictinary used? Clinical cding in a large cmpany 2011 ICH 3

4 Why is clinical cding required? Uncntrlled verbatim frm reprters describes the same adverse event in many ways. Cding classifies data fr subsequent cumulative analysis Example: Headache may be reprted as Tenderness abve temple Dull aches back f head Feels like smene hit back f head 2011 ICH 4

5 When is a clinical cding dictinary used? Preclinical Clinical trials phase I - III Licence applicatin/ prescribing infrmatin Pst marketing PVG, Phase IV clinical trials A clinical cding dictinary is generally used frm the first clinical trial in man and then thrughut the life cycle f the prduct ICH 5

6 Clinical cding in a large cmpany Users include: Clinical data management (statisticians, supprted by dictinary analysts) Clinical trial teams Pharmacvigilance Regulatry Prescribing infrmatin Supprt frm cding dictinary team & infrmatin technlgy Infrmatin stred in: Cding dictinary database (rutine maintenance, versin updates) Clinical trial database Safety (reprting) database Regulatry submissins Prduct labels Pssibly ther lcatins 2011 ICH 6

7 MedDRA implementatin industry Planning Implementatin Database, MedDRA brwser Examples in 2 cmpanies Data cnversin Pilt, Revisin f standard perating prcedures, Training What, when and hw t cnvert 2011 ICH 7

8 Planning Is there a deadline? Regulatr using MedDRA fr electrnic safety reprting - E.g. Eurpe January 2003, Japan April 2000 Sharing safety data fr c-develpment in 2 cmpanies Interdisciplinary prject team Regulatry affairs Pharmacvigilance Data management/dictinary administratrs Clinical research Infrmatin technlgy 2011 ICH 8

9 Implementatin database, MedDRA brwser Older safety databases may nt be MedDRA cmpatible E2B field fr MedDRA terms initially specified 100 characters Many cmmercially available databases nw have MedDRA brwsing capabilities 2011 ICH 9

10 Implementatin examples in 2 cmpanies Cmpany X 1998 MedDRA v1.9 testing fr AERs (FDA database) 2H 1999 in huse terminlgy t MedDRA mapping started IT supprt, dictinary analysts, medical quality cntrl Develped audit trail, MedDRA autencder Intended cmpletin f pharmacvigilance (safety) database mapping in 1Q ICH 10

11 Implementatin examples in 2 cmpanies (2) Cmpany Y Simultaneus planning t migrate t MedDRA Mapping mdified WHO-ART* t MedDRA * less specific than MedDRA On merger f cmpanies X and Y Dictinary teams fund that philsphies were different STOP bth prcesses, AGREE philsphy and RESTART mapping Delayed implementatin in merged cmpany by a year 2011 ICH 11

12 Data cnversin Cmpany X In huse terminlgy mre specific than MedDRA Cntrlled (near verbatim) synnym list mapped t MedDRA LLT Cmpany Y Mdified WHO-ART less specific than MedDRA WHO-ART terms have crrespnding term in MedDRA Cmpany mdified WHO-ART terms mapped t MedDRA LLT Fr n-ging clinical trials: remapped verbatim t MedDRA LLTs t be cnsistent with new data Merged cmpany Implementatin f MedDRA industry Cmmn cding philsphy and medical quality checking 2011 ICH 12

13 Data cnversin (2) Histrical terminlgy: mre specific than MedDRA Histrical: Nervusness (PT), Restlessness (PT) On cnversin t MedDRA: Nervusness (PT), Restlessness (PT) Result: N change in numbers f events less specific than MedDRA Histrical: Nervusness (PT), Restlessness (synnym) On cnversin t MedDRA: Nervusness (PT), Restlessness (PT) Result: Number f reprts f Nervusness falls, new reprts f Restlessness appear 2011 ICH 13

14 Example: less specific terminlgy vs MedDRA 2011 ICH 14

15 Data cnversin (3) May require a pilt (trial perid) with ne prduct Revise standard perating prcedures Cmmunicate with licence partners, clinical research rganisatins (CROs) Training Within cmpany Study investigatrs, CROs etc 2011 ICH 15

16 Data cnversin what, when and hw Safety (reprting) database ften cntains Clinical trial Serius Adverse Events (SAEs) Spntaneus / pst marketing data Clinical trial database cntains Nn serius AEs frm clinical trials Many cnverted safety database befre the clinical trial database. Clinical SAEs in MedDRA and nn serius adverse events (AEs) in ld terminlgy require data recnciliatin r explanatins - Clinical trial reprt may include term mapping in an appendix 2011 ICH 16

17 Data cnversin what, when and hw (2) Impact f cnverting safety database n pst marketing data: Peridic safety update reprts (PSUR) Different bdy systems: e.g. cardivascular split int cardiac and vascular Change in level f detail (granularity) resulting in different number f reprts fr sme AEs Safety mnitring Review new signals fr ptential labelling changes 2011 ICH 17

18 Data cnversin what, when and hw (3) Clinical trial database Start new studies in MedDRA Cnvert nging studies t MedDRA as sn as pssible Integrated data analysis necessary fr submissins Cnvert ld studies t be included in integrated safety summary - Unless ld terminlgy was very specific, cnvert frm reprter verbatim - Cnversin with cdes frm nn specific terminlgy results in lss f detail 2011 ICH 18

19 Thank Yu! 2011 ICH Internatinal Cnference n Harmnisatin f Technical Requirements fr Registratin f Pharmaceuticals fr Human Use 2011 ICH 19