Enhancing clinical evidence by proactively building quality into clinical trials.

ABSTRACT:

Background

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight.

Methods

The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials ("quality-by-design"), such that trials are feasible to conduct and important errors are prevented rather than remedi

SUBMITTER: Meeker-O'Connell A 

PROVIDER: S-EPMC4952025 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature