Summarising salient information on historical controls: A structured assessment of validity and comparability across studies.

ABSTRACT:

Background

While placebo-controlled randomised controlled trials remain the standard way to evaluate drugs for efficacy, historical data are used extensively across the development cycle. This ranges from supplementing contemporary data to increase the power of trials to cross-trial comparisons in estimating comparative efficacy. In many cases, these approaches are performed without in-depth review of the context of data, which may lead to bias and incorrect conclusions.

Methods

We discuss the original 'Pocock' criteria for the use of historical data and how the use of historical data has evolved over time. Based on these factors and personal experience, we created a series of questions that may be asked of historical data, prior to their use. Based on the answers to these q

SUBMITTER: Hatswell A 

PROVIDER: S-EPMC7649932 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature