OBJECTIVES: Translational Research (TR) comprises activities aiming at the gener- ation of biomedical knowledge, its transfer into clinical practice, and the take-up of research questions in biomedical research. It is described as a non-unidirectional process with mutual interexchange between different development stages. Health Technology Assessment (HTA) is predominantly located in later phases of the translational process where implementation, diffusion and dissemination of a technology are focused. METHODS: Within the ELSA-GEN research collaboration, institutional and social aspects of TR in genomic medicine were investigated (TRi- Gen). We performed literature search and expert interviews to build a concept that captures the potential feed-back loops HTA is involved in, and the characteristics of interactions with actors in TR. RESULTS: Traditionally, HTA is applied on a 'societal level' and aims at public and clinical decision-makers. But it can also be performed on a 'project level' to contribute in early phases of development by evaluating premature technologies. In that context, interactions of HTA with man- ufacturers, clinicians and, to a less extent, (basic) researchers become relevant. Interactions are facilitated and shaped by specific organizational and institutional structures. These 'modes of interaction' include approval and reimbursement reg- ulations, funding structures, stakeholder involvement in the HTA process, and prioritization of assessment topics. Formal prerequisites are not fulfilled between all TR players and phases. Our analysis indicates that where they are not in place, the full potential of HTA for the generation and translation of evidence in TR is not met. Feed-back of HTA results regarding evidence gaps into the research agenda could be strengthened. CONCLUSION: HTA can be regarded not only as a tool to promote successful TR, but also as an additional actor that influences the transla- tion of a technology in different stages. Organizational and institutional structures need to be considered to foster its impact on the translation process.
Hunger, T., Schnell-Inderst, P., Hüsing, B., Vignola-Gagné, E., Biegelbauer, P., & Siebert, U. (2011). PHP159 Structures for the Role of Health Technology Assessment in Translational Research. Value in Health, 14(7), A362. https://doi.org/10.1016/j.jval.2011.08.709