Abstract
Clinical trials with adaptive designs use data that accumulate during the course of the study to modify study elements in a prespecified manner. The goal is to provide flexibility such that a trial can serve as a definitive test of its primary hypothesis, preferably in a shorter time period, involving fewer human subjects, and at lower cost. Elements that may be modified include the sample size, end points, eligible population, randomization ratio, and interventions. Accumulating data used to drive these modifications include the outcomes, subject enrollment (including factors associated with the outcomes), and information about the application of the interventions. This review discusses the types of adaptive designs for clinical trials, emphasizing their advantages and limitations in comparison with conventional designs, and opportunities for applying these designs to healthcare epidemiology research, including studies of interventions to prevent healthcare-associated infections, combat antimicrobial resistance, and improve antimicrobial stewardship.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1140-1146 |
| Number of pages | 7 |
| Journal | Clinical Infectious Diseases |
| Volume | 66 |
| Issue number | 7 |
| DOIs | |
| State | Published - Mar 19 2018 |
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Keywords
- Clinical trials
- Drug resistance
- Infection control
- Microbial
- Randomized controlled trials
- Research design
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases
Cite this
Adaptive Designs for Clinical Trials : Application to Healthcare Epidemiology Research. / Huskins, W Charles; Fowler, Vance G.; Evans, Scott.
In: Clinical Infectious Diseases, Vol. 66, No. 7, 19.03.2018, p. 1140-1146.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Adaptive Designs for Clinical Trials
T2 - Application to Healthcare Epidemiology Research
AU - Huskins, W Charles
AU - Fowler, Vance G.
AU - Evans, Scott
PY - 2018/3/19
Y1 - 2018/3/19
N2 - Clinical trials with adaptive designs use data that accumulate during the course of the study to modify study elements in a prespecified manner. The goal is to provide flexibility such that a trial can serve as a definitive test of its primary hypothesis, preferably in a shorter time period, involving fewer human subjects, and at lower cost. Elements that may be modified include the sample size, end points, eligible population, randomization ratio, and interventions. Accumulating data used to drive these modifications include the outcomes, subject enrollment (including factors associated with the outcomes), and information about the application of the interventions. This review discusses the types of adaptive designs for clinical trials, emphasizing their advantages and limitations in comparison with conventional designs, and opportunities for applying these designs to healthcare epidemiology research, including studies of interventions to prevent healthcare-associated infections, combat antimicrobial resistance, and improve antimicrobial stewardship.
AB - Clinical trials with adaptive designs use data that accumulate during the course of the study to modify study elements in a prespecified manner. The goal is to provide flexibility such that a trial can serve as a definitive test of its primary hypothesis, preferably in a shorter time period, involving fewer human subjects, and at lower cost. Elements that may be modified include the sample size, end points, eligible population, randomization ratio, and interventions. Accumulating data used to drive these modifications include the outcomes, subject enrollment (including factors associated with the outcomes), and information about the application of the interventions. This review discusses the types of adaptive designs for clinical trials, emphasizing their advantages and limitations in comparison with conventional designs, and opportunities for applying these designs to healthcare epidemiology research, including studies of interventions to prevent healthcare-associated infections, combat antimicrobial resistance, and improve antimicrobial stewardship.
KW - Clinical trials
KW - Drug resistance
KW - Infection control
KW - Microbial
KW - Randomized controlled trials
KW - Research design
UR - http://www.scopus.com/inward/record.url?scp=85044230010&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85044230010&partnerID=8YFLogxK
U2 - 10.1093/cid/cix907
DO - 10.1093/cid/cix907
M3 - Article
C2 - 29121202
AN - SCOPUS:85044230010
VL - 66
SP - 1140
EP - 1146
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 7
ER -