Berger Vance W, Matthews J Rosser, Grosch Eric N
National Cancer Institute, University of Maryland, Baltimore, MD, USA.
Stat Methods Med Res. 2008 Jun;17(3):231-42. doi: 10.1177/0962280207080639. Epub 2007 Oct 9.
Research plays a vital role within biomedicine. Scientifically appropriate research provides a basis for appropriate medical decisions; conversely, inappropriate research may lead to flawed ;best medical practices' which, when followed, contribute to avoidable morbidity and mortality. Although an all-encompassing definition of ;appropriate medical research' is beyond the scope of this article, the concept clearly entails (among other things) that research methods be continually revised and updated as better methods become available. Despite the advent of evidence-based medicine, many research methods have become ;standard' even though there are legitimate scientific reasons to question the conclusions reached by such methods. We first illustrate prominent examples of inappropriate (yet regimented) research methods that are in widespread use. Second, as a way to improve the situation, we suggest a model of research that relies on standardized statistical analyses that individual researchers must consider as a default, but are free to challenge when they can marshal sufficient scientific evidence to demonstrate that the challenge is warranted. Third, we characterize the current system as analogous to ;unnatural selection' in the biological world and argue that our proposed model of research will enable ;natural' to replace ;unnatural' selection in the choice of research methodologies. Given the pervasiveness of inappropriate research methods, we believe that there are strong scientific and ethical reasons to create such a system, that, if properly designed, will both facilitate creativity and ensure methodological rigor while protecting the public at large from the threats posed by poor medical treatment decisions resulting from flawed research methodology.
研究在生物医学中起着至关重要的作用。科学上恰当的研究为恰当的医疗决策提供依据；相反，不恰当的研究可能导致有缺陷的“最佳医疗实践”，而遵循这些实践会导致可避免的发病率和死亡率。尽管本文无法给出“恰当的医学研究”的全面定义，但这一概念显然（尤其）要求随着更好的方法出现，研究方法要不断修订和更新。尽管循证医学已经出现，但许多研究方法已成为“标准”方法，即便有合理的科学理由对这些方法得出的结论提出质疑。我们首先举例说明广泛使用的不恰当（但规范）的研究方法。其次，为改善这种情况，我们提出一种研究模式，该模式依赖于标准化统计分析，个别研究人员必须将其视为默认方法，但如果他们能拿出充分的科学证据证明质疑有理，也可以对其提出挑战。第三，我们将当前的体系描述为类似于生物界的“非自然选择”，并认为我们提出的研究模式将使“自然”选择取代研究方法选择中的“非自然”选择。鉴于不恰当研究方法的普遍存在，我们认为有充分的科学和伦理理由创建这样一个体系，该体系如果设计得当，将既能促进创造力，又能确保方法的严谨性，同时保护广大公众免受因有缺陷的研究方法导致的不当医疗决策所带来的威胁。
