PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.

ABSTRACT: Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single-sponsor, single-drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real-world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints-aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make co

SUBMITTER: Trusheim MR 

PROVIDER: S-EPMC5142736 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature