Review of tools to support Target Trial Emulation.

Abstract

Randomized Controlled Trials (RCTs) are the gold standard for clinical evidence, but ethical and practical constraints sometimes necessitate or warrant the use of observational data. The aim of this study is to identify informatics tools that support the design and conduct of Target Trial Emulations (TTEs), a framework for designing observational studies that closely emulate RCTs so as to minimize biases that often arise when using real-world evidence (RWE) to estimate causal effects. We divided the process of conducting TTEs into three phases and seven steps. We then systematically reviewed the literature to identify currently available tools that support one or more of the seven steps required to conduct a TTE. For each tool, we noted which step or steps the tool supports. 7625 papers were included in the initial review, with 76 meeting our inclusion criteria. Our review identified 24 distinct tools applicable to the three phases of TTE. Specifically, 3 tools support the Design Phase, 5 support the Implementation Phase, and 19 support the Analysis Phase, with some tools applicable to multiple phases. This review revealed significant gaps in tool support for the Design Phase of TTEs, while support for the Implementation and Analysis phases was highly variable. No single tool currently supports all aspects of TTEs from start to finish and few tools are interoperable, meaning they cannot be easily integrated into a unified workflow. The results highlight the need for further development of informatics tools for supporting TTEs.