title: Adaptive designs for randomized trials in public health.
abstract: In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials.
authors.affiliation: Prevention Science and Methodology Group, Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, 33612, USA. hbrown@health.usf.edu
authors.forename: C Hendricks
authors.initials: CH
authors.lastname: Brown
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ten Have
authors.forename: Booil
authors.initials: B
authors.lastname: Jo
authors.forename: Getachew
authors.initials: G
authors.lastname: Dagne
authors.forename: Peter A
authors.initials: PA
authors.lastname: Wyman
authors.forename: Bengt
authors.initials: B
authors.lastname: Muthén
authors.forename: Robert D
authors.initials: RD
authors.lastname: Gibbons
mesh_terms: D003657:Decision Making; D055317:Evidence-Based Practice; D005380:Financing, Government; D006801:Humans; D009316:National Institutes of Health (U.S.); D015980:Public Health Practice; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods*; D012107:Research Design; D014481:United States