Principles and procedures for data and safety monitoring in pragmatic clinical trials.

ABSTRACT:

Background

All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials.

Methods/results

Appropriate monitoring of clinical trials typically includes assessing rate of recruitment or enrollment; monitoring safe and effective delivery of study treatments; assuring that study staff act to minimize risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility. Each of these responsibilities applies to pragmatic clinical trials. Just as design of pragmatic trials typically involves specific

SUBMITTER: Simon GE 

PROVIDER: S-EPMC6902512 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature