Experience using MedDRA for global events coding in HIV clinical trials.
OBJECTIVE
To assess the feasibility of coding with MedDRA, the Medical Dictionary for Regulatory Activities, not only serious adverse events required for notification but also all other events usually reported in HIV clinical trials. To develop an approach for MedDRA implementation within an institutional research unit that contributes to an efficient, concise and reproducible event coding. To evaluate the impact of the maintenance and the versioning of this new medical terminology.


METHODS
MedDRA versions 3.0 and 5.0 were used for coding hundreds of events reported through two HIV clinical trials. The implementation of MedDRA consisted in the setup of a training program, guidelines to clinical investigators, coding rules and medical validation process. MedDRA version 6.1 was applied to the coding made with the MedDRA version 5.0 in order to identify the assignments affected by the new version and to determine the impact of versioning.


RESULTS
Coding with MedDRA all types of events in HIV clinical trials was feasible even though coders experienced some difficulties due mainly to the lack of precision in the investigator verbatim and the high specificity and sensitivity of MedDRA. The addition of appropriate tools to support the use of MedDRA improved significantly the coding of all types of events in HIV clinical trials. The impact of MedDRA versioning was limited and did not result in significant issues. The global implementation process of MedDRA required important resources in terms of qualified personnel, organisation and maintenance.


CONCLUSIONS
Guidelines for investigators, coding rules and medical validation appeared to be mandatory for a successful implementation of MedDRA. The use of MedDRA, with the addition of the mentioned support tools, should ensure coding consistency and facilitate the clinical and tolerance analyses and meta-analyses in clinical trials.
Tonéatti
Christine
C
INSERM (Institut National de la Santé et de la Recherche Médicale), Service Commun 10, 16 Avenue Paul Vaillant Couturier, 94807 Villejuif, France. toneatti@pasteur.fr
Saïdi
Yacine
Y
Meiffrédy
Vincent
V
Tangre
Philippe
P
Harel
Marine
M
Eliette
Véronique
V
Dormont
Jean
J
Pierre Aboulker
Jean
J
D016907:Adverse Drug Reaction Reporting Systems; D019380:Anti-HIV Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods*; D004018:Dictionaries, Medical as Topic; D005568:Forms and Records Control / Q000379:methods; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D009626:Terminology as Topic
D019380:Anti-HIV Agents