Innovative Clinical Trial Designs: Toward a 21st-Century Health Care System

Stat Biosci. 2011 Dec;3(2):145-168. doi: 10.1007/s12561-011-9042-5.

Abstract

Whereas the 20th-century health care system sometimes seemed to be inhospitable to and unmoved by experimental research, its inefficiency and unaffordability have led to reforms that foreshadow a new health care system. We point out certain opportunities and transformational needs for innovations in study design offered by the 21st-century health care system, and describe some innovative clinical trial designs and novel design methods to address these needs and challenges.

Keywords: Cancer clinical trials; Comparative effectiveness research; Embedded experiments; Personalized therapies; Sequential design and randomization.