In October, I traveled to Kampala, Uganda to conduct CDASH training for the US NIH’s National Institute of Allergy and Infectious Diseases (NIAID) at the Infectious Disease Institute (IDI). Trainees were data specialists from NIAID’s International Centers of Excellence for Malaria Research (ICEMR) program, which has established a global network of independent research centers in malaria-endemic settings to provide knowledge, tools, and evidence-based strategies to support researchers working in a variety of settings, especially within governments and healthcare institutions. There was also a lot of interest from Investigators in the Tropical Medicine Research Center, who are involved in research on Leishmaniosis, Chagas Disease, Zika and Chikungunya.
The primary investigators involved with ICEMR want to share their data so that it could be examined for more insights and answer new questions based on existing data. To achieve this goal, the data need to be structured the same i.e., standardized. As NIAID actively works with CDISC standards, they recommended that ICEMR pursue this course of action. Data managers and other data specialists from many of their member sites came together in Kampala to learn how CDASH works and how it will benefit their research. The course covered the basics of CDASH and how it fits into the larger world of CDISC standards, how it's structured, best practices for capturing data in a standardized environment, and guidance for implementing CDASH in their studies. Part of their challenge is that their studies are mostly observational, and while CDISC standards can be used for non-interventional studies, they require a little more interpretation. The class generated excellent discussions around what parts of the standards were immediately usable, and how to approach standardizing data for studies that had already started, and how to transition to standards usage.
NIAID funds many projects in Uganda, which aim to reduce transmission of infectious diseases in rural communities. Other NIAID-supported projects in the country include research on HIV and TB co-infection and studies on the efficacy of antimalarial drug combinations in treating Ugandan children. Version 2 of the CDISC Therapeutic Area User Guide (TAUG) for Tuberculosis was released in 2016 in partnership with C-Path. Additionally, NIAID has partnered with CDISC on developing a TAUG for HIV, which will be available Q1 2018.
Earlier this year, CDISC and the WorldWide Antimalarial Resistance Network (WWARN) announced the availability of CDISC Malaria Therapeutic Area (TA) User Guide v1.0, the first global malaria data standard that enables data capture and assessment for antimalarial drug efficacy, with the potential to speed the delivery of new and better therapies to patients afflicted with malaria.