The standard management strategy for drug-sensitive (DS) pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months. Patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat.
This trial evaluates an alternative strategy of treating patients with DS-TB for 2 months with combinations including new drugs or optimised doses of currently available drugs, chosen for their sterilising efficacy. The secondary aim is to assess the possible advantages of the TRUNCATE-TB management strategy compared to the standard management strategy from the patient perspective, the programme perspective and to assess cost-effectiveness. This trial also looks into evaluating the pharmacokinetics, microbiological efficacy and toxicity of a number of boosted 8-week regimens in comparison to the standard treatment regimen; and to explore the relationship between various biomarkers and sterilisation/cure.
Sponsored by the University College London and supported by The International Union Against TB and Lung Disease, the trial is managed as a partnership between National University Hospital (Singapore) and the Medical Research Council Clinical Trials Unit at University College London. SCRI Biostatistics, Data Management, Research Informatics and Project Management departments took part in the trial.
The Data Management department was responsible for the database design and managed the data collection and data transfer processes. Due to the use of novel approaches outlined in the TRUNCATE-TB management strategy, the Trial Coordinating Centre (TCC) recognised the need for close monitoring of the sites to ensure all personnel followed the respective trial SOPs meticulously. To achieve the desired level of central monitoring, different kinds of customised reports of varying complexities were required periodically.
For example, all expected central laboratory test samples must be submitted and their results collected into the EDC system. Through the use of a customised report, the TCC is able to identify lapses in sample submission or data entry of test results, and could rectify these findings with the respective sites immediately.
The generation of such customised reports, along with the routine data reports, which are provided on monthly and quarterly basis, was supported by the SCRI Data Management with the use of wizard-driven analytics tool like the SAS Enterprise Guide.