Augmenting control arms with real-world data for cancer trials: Hybrid control arm methods and considerations.

ABSTRACT:

Background

Hybrid controlled trials with real-world data (RWD), where the control arm is composed of both trial and real-world patients, could facilitate research when the feasibility of randomized controlled trials (RCTs) is challenging and single-arm trials would provide insufficient information.

Methods

We propose a frequentist two-step borrowing method to construct hybrid control arms. We use parameters informed by a completed randomized trial in metastatic triple-negative breast cancer to simulate the operating characteristics of dynamic and static borrowing methods, highlighting key trade-offs and analytic decisions in the design of hybrid studies.

Results

Simulated data were generated under varying residual-bias assumptions (no bias: HR_RWD = 1) and e

SUBMITTER: Tan WK 

PROVIDER: S-EPMC9519429 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature