Adaptive designs for randomized trials in public health.
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.
Brown
C Hendricks
CH
Prevention Science and Methodology Group, Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, 33612, USA. hbrown@health.usf.edu
Ten Have
Thomas R
TR
Jo
Booil
B
Dagne
Getachew
G
Wyman
Peter A
PA
Muthén
Bengt
B
Gibbons
Robert D
RD
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