ADEPT (Multi-centre Infectious Diseases Trial)
Adult Dengue Platelet Study (ADEPT) is the first local Investigator-initiated, multi-centred, randomised-controlled trial on prophylactic platelet transfusion for dengue patients with severe thrombocytopenia. It compares patients given supportive care and platelet transfusion versus supportive care alone. The Study aims to determine whether platelet transfusion should be given prophylactically to prevent bleeding in dengue patients. The findings are vital to support good clinical practices not restricted to local practices but globally.
ADEPT has enrolled 372 patients since Apr 2010 and is in the final stages of study analysis for the Clinical Study Report. ADEPT has been supported by SCRI’s Project Management, Research Monitoring, Biostatistics and Research Informatics Departments. Year 2014 was crucial for ADEPT as it was the last recruitment year. Despite facing challenging recruitment delays at first – with more than 141 subjects required by the end of 2014, both Singapore and Malaysian study sites worked hard together to successfully achieve its target a month ahead of schedule.
SCRI’s Project Management Team provided robust support with the recruitment through proactive reviews of the prescreening and screen-failure data. Through close follow-ups, regular sharing of sites’ best practices with study teams during monthly project meetings and consistent weekly updates of recruitment status, the Team was able to help identify potential recruitment issues.
Another challenge was to resolve more than 4,500 data queries within nine months, so that clean data could be analysed for the final Clinical Study Report before the study grant closure. This milestone was successfully achieved on time as SCRI’s Team played a close facilitative role in addition to Tan Tock Seng Hospital (TTSH) strong administrative support from clinical investigators. SCRI’s efforts leading up to this successful data cleaning included implementing training on the completion of case report forms, data query tracking and active follow-up.