Schulte P A, Perera F P
National Institute for Occupational Safety and Health, Cincinnati, OH 45226, USA.
IARC Sci Publ. 1997(142):19-29.
Transitional studies are studies using biological markers that bridge the gap between laboratory experiments and population-based epidemiology. The goal of these studies is to characterize and validate biomarkers and to assess the following: intra- and inter-subject variability; the feasibility of marker use in field conditions; confounding and effect-modifying factors for the marker; and mechanisms reflected by the biomarker. Another goal is to optimize the conditions for the use of biomarkers. Transitional studies involving biomarkers of exposure or effect are distinguished from etiological studies because the biomarker is generally the outcome or dependent variable. Despite this difference, transitional studies can be epidemiological studies, but they may also include laboratory studies to assess reliability (and accuracy) and to identify parameters for collecting, processing and storing biological specimens prior to assay. Generally, transitional studies involve healthy people, patients or workers with specific exposures. At some point in the validation of a biomarker the line between transitional and etiological studies becomes blurred. None the less, it is useful to identify transitional studies as a distinct set of efforts to validate and characterize biomarkers. Transitional studies can be divided into three functional categories: developmental, characterization and applied studies.
过渡性研究是利用生物标志物的研究，这些生物标志物弥合了实验室实验与基于人群的流行病学之间的差距。这些研究的目标是对生物标志物进行表征和验证，并评估以下内容：个体内和个体间的变异性；标志物在现场条件下使用的可行性；标志物的混杂因素和效应修饰因素；以及生物标志物所反映的机制。另一个目标是优化生物标志物的使用条件。涉及暴露或效应生物标志物的过渡性研究与病因学研究不同，因为生物标志物通常是结果或因变量。尽管存在这种差异，过渡性研究可以是流行病学研究，但它们也可能包括实验室研究，以评估可靠性（和准确性），并确定在检测前收集、处理和储存生物标本的参数。一般来说，过渡性研究涉及健康人、患者或有特定暴露的工人。在生物标志物验证的某个阶段，过渡性研究和病因学研究之间的界限会变得模糊。尽管如此，将过渡性研究确定为验证和表征生物标志物的一组独特工作是有用的。过渡性研究可分为三个功能类别：发育性研究、表征性研究和应用性研究。
