공익적 임상연구를 위한 연구설계 결정과정: 환자중심 의료기술 최적화 연구(PACEN) 과제화를 중심으로

Abstract

Health technology assessment (HTA) includes the synthesis of current evidence to support healthcare decision-making. In cases of the limited, contradictory, or uncertain evidence, it requires the generation of trustworthy evidence through rigorous health research to support better decisionmaking. Patient-Centered Clinical Research Coordinating Center (PACEN) is a investigator-initiated research program funded by government, to answer the practical questions raised in real-world settings. It includes systematic process such as topic suggestions from various stakeholders and developing them into research proposals through the reviews of advisory groups involving relevant professionals and the public contributors. The important step in research development is specifying the research questions and determining appropriate study designs to explore the questions. This paper concerns the latter and introduces the process in PACEN that supports the discussion and consensus among the advisory group members to decide study designs for research questions. PACEN supports the four types of evidence-generation studies: randomized controlled trials (RCTs), cluster non-RCTs (cluster non-RCTs), prospective cohorts, and retrospective cohorts. Two diagrams are sequentially applied to determine the appropriate study designs among them once either the evidence synthesis or generation is decided with the first diagram, one of the four study types is decided with the second one. Some cases of utilizing the diagrams in determining of PACEN’s clinical research designs are provided. It expects that clinical research developed based on the efforts and collaboration of many stakeholders at PACEN, will be linked in a circular way to HTA and health policy decision-making.