My name is Dridah Nakiboneka Luyirika from Kampala Uganda. I am a Monitoring and Evaluation specialist (Pgd Monitoring & Evaluation) with a Statistics (Bsc Statistics) background. I have been working as a Data Manager on clinical trials for five years.
I have worked with the The Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST publication here) clinical trial: This randomised controlled trial aimed to evaluate options for second-line therapy in HIV patients failing a first-line 2NRTI + NNRTI regimen antiretroviral therapy for HIV positive individuals who need to switch to second line antiretroviral therapy in a resource-limited setting.
Strategic Timing of Antiretroviral Treatment (START publication here) study: The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 (subsequently referred to as HIV) infected persons who are antiretroviral naïve with a CD4+ count above 500 cells/mm3. Interim results were released in May 2015 with a recommendation to start ART immediately
My work includes; data entry, review of Clinical research documents (Protocols, Case Report Forms, Reports, and Statistical data analysis plans), develop Data Management Plans & SOPs and maintain them throughout the study project lifecycle while ensuring the plans are followed according to study designs and requirements, Develop Case Report Forms both electronic and hard copy.
I also work as a Statistician in a general ART clinic at Joint Clinical Research Centre a clinical research organization that also offers general HIV care in Uganda. My duties here include assist in defining and creating data listings, summary table validation, data specifications and process data transfers in preparation for statistical review and data management audits, provide input into study and project level data analysis plan.
My greatest achievement has been the ability to work within systems that are in place and the capability to think outside of them.
The biggest challenge I face is that clinical trials’ databases are designed and only availed to sites to use. These databases sometimes miss out information that would inform further research. I very often feel a lot of data is left unutilized yet it is available. As a statistician who loves using information I always term this as ‘data wastage’
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