Phases of methodological research in biostatistics-Building the evidence base for new methods.

ABSTRACT: Although new biostatistical methods are published at a very high rate, many of these developments are not trustworthy enough to be adopted by the scientific community. We propose a framework to think about how a piece of methodological work contributes to the evidence base for a method. Similar to the well-known phases of clinical research in drug development, we propose to define four phases of methodological research. These four phases cover (I) proposing a new methodological idea while providing, for example, logical reasoning or proofs, (II) providing empirical evidence, first in a narrow target setting, then (III) in an extended range of settings and for various outcomes, accompanied by appropriate application examples, and (IV) investigations that establish a method as sufficiently w

SUBMITTER: Heinze G 

PROVIDER: S-EPMC7615508 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature