A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data.

ABSTRACT: Several approaches have been proposed recently to accelerate the pathway from drug discovery to patient access. These include novel designs such as using controls external to the clinical trial where standard randomised controls are not feasible. In parallel, there has been rapid growth in the application of routinely collected healthcare 'real-world' data for post-market safety and effectiveness studies. Thus, using real-world data to establish an external comparator arm in clinical trials is a natural next step. Regulatory authorities have begun to endorse the use of external comparators in certain circumstances, with some positive outcomes for new drug approvals. Given the potential to introduce bias associated with observational studies, there is a need for recommendations on how exter

SUBMITTER: Gray CM 

PROVIDER: S-EPMC7305259 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature