O'Kelly Michael, Anisimov Vladimir, Campbell Chris, Hamilton Sinéad
Quintiles, Dublin, Ireland.
University of Glasgow, Glasgow, Scotland.
Pharm Stat. 2017 Mar;16(2):107-113. doi: 10.1002/pst.1789. Epub 2016 Nov 3.
Modelling and simulation has been used in many ways when developing new treatments. To be useful and credible, it is generally agreed that modelling and simulation should be undertaken according to some kind of best practice. A number of authors have suggested elements required for best practice in modelling and simulation. Elements that have been suggested include the pre-specification of goals, assumptions, methods, and outputs. However, a project that involves modelling and simulation could be simple or complex and could be of relatively low or high importance to the project. It has been argued that the level of detail and the strictness of pre-specification should be allowed to vary, depending on the complexity and importance of the project. This best practice document does not prescribe how to develop a statistical model. Rather, it describes the elements required for the specification of a project and requires that the practitioner justify in the specification the omission of any of the elements and, in addition, justify the level of detail provided about each element. This document is an initiative of the Special Interest Group for modelling and simulation. The Special Interest Group for modelling and simulation is a body open to members of Statisticians in the Pharmaceutical Industry and the European Federation of Statisticians in the Pharmaceutical Industry. Examples of a very detailed specification and a less detailed specification are included as appendices.
在开发新疗法时，建模与模拟已被广泛应用于多种方式。为了有用且可信，人们普遍认为建模与模拟应按照某种最佳实践来进行。许多作者提出了建模与模拟最佳实践所需的要素。已被提出的要素包括目标、假设、方法和输出的预先设定。然而，一个涉及建模与模拟的项目可能简单或复杂，并且对该项目的重要性可能相对较低或较高。有人认为，应根据项目的复杂性和重要性，允许细节程度和预先设定的严格程度有所不同。本最佳实践文件并未规定如何开发统计模型。相反，它描述了项目规范所需的要素，并要求从业者在规范中说明省略任何要素的理由，此外，还要说明为每个要素提供的细节程度的理由。本文件是建模与模拟特别兴趣小组的一项倡议。建模与模拟特别兴趣小组是一个向制药行业统计学家协会成员和制药行业欧洲统计学家联合会开放的机构。附录中包含了非常详细的规范和不太详细的规范的示例。
