Development and hosting of central database platform for collection of safety data in the scope of active TB drug-safety monitoring

WHO estimates that up to half a million new cases of multidrug-resistant tuberculosis (MDR-TB) occur worldwide, each year. Current
treatment regimens for MDR-TB present many challenges. For the first
time in over 40 years, a new TB drug with a novel mechanism of action
– bedaquiline – is available. However, information about this new
drug remains limited. In 2013, the WHO interim policies on bedaquiline
in the combination therapy of MDR-TB for MDR-TB patients recommended
active pharmacovigilance as one of the conditions to be met when these
drugs are used. In that context, countries are expected to maintain
country specific database containing the related safety data obtained
from active safety surveillance of TB drugs.
The creation under the umbrella of the WHO Global TB program of a
global central database to pool anti-TB drug-safety data collected in
different countries through active surveillance of TB drug safety was
envisaged to consolidate the information available. The central
database is designed initially to collect data on adverse events /
serious adverse events.
The establishment of a TB clinical platform is in line with the
recommendations made by the H8 health organizations which called for
greater access to global health data as an essential component to
accurately track and monitor progress in health.
Data curation is a key activity when dealing with multiple and diverse
databases in order to ensure common structure which will allow pooled
analyses; data cleaning in particular is critical in obtaining a highquality database.
The present APW cover the programming and hosting of the central
database as well as curation of the data transferred.