The US National Institute of Allergy and Infectious Diseases (NIAID) restructured its HIV/AIDS Clinical Trials Networks in 2006 to address six high priority areas of research. As the world’s largest HIV/AIDS clinical preventative and therapeutic research program, this system of research presents formidable evaluation challenges, some common to other large-scale scientific initiatives (e.g. multiplicity of goals and agendas), and others unique to the scientific, social, and ethical issues of global HIV/AIDS research. The restructuring of the NIAID HIV/AIDS Clinical Trials Networks is an example of the broader transformation of science towards large collaborative research initiatives, including in their organization, management, conduct, and dissemination. This trend calls for the thorough development of comprehensive and integrated systems for managing and evaluating large-scale, multi-site, collaborative scientific research initiatives.
CSI was asked to support the development of a comprehensive evaluation system for the newly restructured HIV/AIDS Clinical Trial Networks, in conjunction with the new Office of HIV/AIDS Network Coordination (HANC). Using The Concept System®, CSI helped to identify and engage a diverse array of stakeholders with familiarity with HIV/AIDS clinical research to define and prioritize critical success factors for the coordinated HIV/AIDS Clinical Trial Networks. Participants worldwide included government staff, scientific researchers, community members, and industry representatives.
Over 300 stakeholders participated in idea generation, responding to the prompt “Coordinated clinical research networks will be successful if…”. Ninety stakeholders completed the conceptual sorting process, and 323 completed ratings of importance. Ninety-one statements that described the success factors for the coordinated HIV/AIDS Clinical Trial Networks were captured and organized by participants into eight clusters and four domains. Group concept mapping was the centerpiece of the evaluation framework development process, and was the basis of a logic model for the NIAID HIV/AIDS Clinical Trial Networks evaluation. Task force members representing the four regions of the concept map identified evaluation questions that corresponded with the groupings of success factors, potential measures that aligned with those questions, approaches for measurement, and next steps for moving forward with an evaluation agenda in that area. The stakeholder-constructed framework of critical success factors enabled a prospective view across the four domains where evaluation activities and processes have been designed and adjusted to provide information that aligns with the research initiative.
Now in Phase III of the project, CSI has helped to refine of the evaluation design and measurement approach, and is implementing complex, multifaceted evaluation studies in the four domains. To view the full article Developing a Conceptual Framework for an Evaluation System for the NIAID HIV/AIDS Clinical Trials Networks (Kagan et al., 2009), click here.