Bayesian techniques to using historical data in clinical trial analyses

Historical data from past clinical studies are usually considered while developing clinical trials. For example, to calculate the variance and clinically relevant effect size for a sample size calculation or gather data on recruitment rates and population sizes. However, it appears that historical data is rarely employed in clinical trial analyses.

One way to include historical data into a clinical trial’s analysis is to use historical controls to replace or complement current controls. Numerous assumptions must be valid for the historical control group when using this method (s). The historical control group(s) must, for example, (1) have received the same precisely specified standard therapy as the randomized controls in the current trial, and (2) have participated in a prior clinical study with the similar subject inclusion and exclusion criteria. Additional specifications may be found in.

There are several Bayesian approaches for incorporating historical control data from single research into trial data analysis. The Power prior, Hierarchical Power prior, Modified Power prior, and Commensurate prior are among them. While the most basic pooling technique assumes that the historical controls are equivalent to the current study’s randomized controls, additional ways down weight previous data. Pubrica’s team of researchers and authors create scientific and clinical techniques that can serve as a valuable resource for historical data and research analysis.

Two Meta analytical techniques may be used to include historical control data from numerous clinical trials into the analysis of new research, in addition to the Power prior and commensurate prior. The retrospective Meta analytical combination (MAC) analysis combines previous and current data to produce a meta-analysis. This may be a non-Bayesian analysis. The prospective Meta analytical-predictive (MAP) analysis does a meta-analysis of historical data to create a MAP prior, which is then coupled with current data using the Bayesian rule. The gold standard is the meta-analytic previous (MAP), utilized in numerous published researches.

References

Hobbs B et al. (2012) Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models. Bayesian Analysis 7(3):639-674