Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials.

ABSTRACT:

Background

Decentralized clinical trials offer the promise of reduced patient burden, faster and more diverse recruitment, and have received regulatory support during the COVID-19 pandemic. However, lack of data accuracy or data validation poses a challenge for fully decentralized trials. A mixed data collection modality where onsite measurements are collected at key time points and decentralized measurements are taken at intermediate time points is attractive operationally. To date, the impact of decentralized measurements (which could presumably be less accurate) taken at intermediate time points on statistical inference on the primary or other key time points has not been evaluated.

Methods

In this article we evaluate the estimation and statistical inference for three sce

SUBMITTER: Curtis A 

PROVIDER: S-EPMC9128333 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature