Dynamic borrowing from a single prior data source using the conditional power prior. Issue 4 (4th July 2021)

• Record Type: Journal Article
• Authors: Thompson, Laura; Chu, Jianxiong; Xu, Jianjin; Li, Xuefeng; Nair, Rajesh; Tiwari, Ram
• Is Part Of: Journal of biopharmaceutical statistics. Volume 31:Issue 4(2021)
• Page Start: 403
• Page End: 424
• Publication Date: 2021-07-04
• Subjects: Power prior -- Bayesian -- adaptive -- clinical similarity margin; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2021.1895190
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: The conditional power prior is a popular method to borrow information from a single prior data source. The amount of borrowing is controlled by the power parameter which is fixed before running the new study. However, fixing this parameter before running a new study is often difficult and may be unwise because if the outcomes in the current study are much different from the prior data outcomes, the power parameter cannot be changed to reflect a more appropriate degree of borrowing. On the other hand, treating the power parameter as a random variable to be updated via Bayes theorem may relinquish control over how much to borrow in cases where regulatory oversight recommends a conservative approach.Previous authors have determined the power parameter at the end of the current study based on "stochastic" similarity in the outcomes between the current study and the prior data. In this paper, we introduce some modifications to those methods. First, we determine the power parameter based on similarity between a percentage of the current study outcome data available at an interim look and the prior outcome data. This may limit potential for operational bias resulting from the determination of the power parameter after the current study is complete. Next, we introduce a new measure of similarity between the current (interim) and prior data that limits similarity by a pre-specified clinical margin. The proposed clinical similarity region may be readily understood by clinicians who need to assess when such borrowing is clinically appropriate. Through simulations, we show that our approach has low bias and good power, while reducing type I error rate in areas outside of the "similarity region". An example of a hypothetical medical device study illustrates its potential use in practice.