Use of Historical Individual Patient Data in Analysis of Clinical Trials

Abstract: Historical data from previous clinical trials, observational studies and health records may be utilized in analysis of clinical trials data to strengthen inference. Under the Bayesian framework incorporation of information obtained from any source other than the current data is facilitated through construction of an informative prior. The existing methodology for defining an informative prior based on historical data relies on measuring similarity to the current data at the study level and does not take advantage of individual patient data (IPD). This paper proposes a family of priors that utilize IPD to strengthen statistical inference. It is demonstrated that the proposed prior construction approach outperforms the existing methods where the historical data are partially exchangeable with the present data. The proposed method is applied to IPD from a set of trials in non-small cell lung cancer.