Sequential Multiple Assignment Randomized Treatment (SMART)

Designs in Bipolar Disorder Clinical Trials

Charles L. Bowden, Vivek Singh

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

In addition to an initial randomization, Sequential Multiple Assignment Randomized Treatment (SMART) methodologies allow the sequential introduction of a second randomized intervention based on a patient's state and response during the trial. SMART designs resemble the adaptive nature of treatment selection that occurs in clinical settings. The advantages of SMART include yielding more inclusive enrollment, thereby enhancing generalizability of results. With single front end randomization, if any of the treatment options are unacceptable, the patient is excluded from the study or will choose not to enter. SMART studies focus on effectiveness both by emphasizing sustained benefit and efficacy in conjunction with tolerability, in contrast to outcomes based on single point in time assessment. The controlled design allows causal inference and eliminates unmeasured confounders associated with nonrandomized treatment decisions.

Original languageEnglish (US)
Title of host publicationClinical Trial Design Challenges in Mood Disorders
PublisherElsevier Inc.
Pages75-86
Number of pages12
ISBN (Print)9780124051768, 9780124051706
DOIs
StatePublished - Jan 22 2015

Fingerprint

Bipolar Disorder
Clinical Trials
Random Allocation
Therapeutics

Keywords

  • Bipolar
  • Clinical trials
  • Effectiveness
  • Generalizability
  • Methodologies
  • Randomized

ASJC Scopus subject areas

  • Psychology(all)

Cite this

Bowden, C. L., & Singh, V. (2015). Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials. In Clinical Trial Design Challenges in Mood Disorders (pp. 75-86). Elsevier Inc.. https://doi.org/10.1016/B978-0-12-405170-6.00007-5

Sequential Multiple Assignment Randomized Treatment (SMART) : Designs in Bipolar Disorder Clinical Trials. / Bowden, Charles L.; Singh, Vivek.

Clinical Trial Design Challenges in Mood Disorders. Elsevier Inc., 2015. p. 75-86.

Research output: Chapter in Book/Report/Conference proceedingChapter

Bowden, CL & Singh, V 2015, Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials. in Clinical Trial Design Challenges in Mood Disorders. Elsevier Inc., pp. 75-86. https://doi.org/10.1016/B978-0-12-405170-6.00007-5
Bowden CL, Singh V. Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials. In Clinical Trial Design Challenges in Mood Disorders. Elsevier Inc. 2015. p. 75-86 https://doi.org/10.1016/B978-0-12-405170-6.00007-5
Bowden, Charles L. ; Singh, Vivek. / Sequential Multiple Assignment Randomized Treatment (SMART) : Designs in Bipolar Disorder Clinical Trials. Clinical Trial Design Challenges in Mood Disorders. Elsevier Inc., 2015. pp. 75-86
@inbook{81c0af5c2c634a43a9728e9b4dab95e8,
title = "Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials",
abstract = "In addition to an initial randomization, Sequential Multiple Assignment Randomized Treatment (SMART) methodologies allow the sequential introduction of a second randomized intervention based on a patient's state and response during the trial. SMART designs resemble the adaptive nature of treatment selection that occurs in clinical settings. The advantages of SMART include yielding more inclusive enrollment, thereby enhancing generalizability of results. With single front end randomization, if any of the treatment options are unacceptable, the patient is excluded from the study or will choose not to enter. SMART studies focus on effectiveness both by emphasizing sustained benefit and efficacy in conjunction with tolerability, in contrast to outcomes based on single point in time assessment. The controlled design allows causal inference and eliminates unmeasured confounders associated with nonrandomized treatment decisions.",
keywords = "Bipolar, Clinical trials, Effectiveness, Generalizability, Methodologies, Randomized",
author = "Bowden, {Charles L.} and Vivek Singh",
year = "2015",
month = "1",
day = "22",
doi = "10.1016/B978-0-12-405170-6.00007-5",
language = "English (US)",
isbn = "9780124051768",
pages = "75--86",
booktitle = "Clinical Trial Design Challenges in Mood Disorders",
publisher = "Elsevier Inc.",

}

TY - CHAP

T1 - Sequential Multiple Assignment Randomized Treatment (SMART)

T2 - Designs in Bipolar Disorder Clinical Trials

AU - Bowden, Charles L.

AU - Singh, Vivek

PY - 2015/1/22

Y1 - 2015/1/22

N2 - In addition to an initial randomization, Sequential Multiple Assignment Randomized Treatment (SMART) methodologies allow the sequential introduction of a second randomized intervention based on a patient's state and response during the trial. SMART designs resemble the adaptive nature of treatment selection that occurs in clinical settings. The advantages of SMART include yielding more inclusive enrollment, thereby enhancing generalizability of results. With single front end randomization, if any of the treatment options are unacceptable, the patient is excluded from the study or will choose not to enter. SMART studies focus on effectiveness both by emphasizing sustained benefit and efficacy in conjunction with tolerability, in contrast to outcomes based on single point in time assessment. The controlled design allows causal inference and eliminates unmeasured confounders associated with nonrandomized treatment decisions.

AB - In addition to an initial randomization, Sequential Multiple Assignment Randomized Treatment (SMART) methodologies allow the sequential introduction of a second randomized intervention based on a patient's state and response during the trial. SMART designs resemble the adaptive nature of treatment selection that occurs in clinical settings. The advantages of SMART include yielding more inclusive enrollment, thereby enhancing generalizability of results. With single front end randomization, if any of the treatment options are unacceptable, the patient is excluded from the study or will choose not to enter. SMART studies focus on effectiveness both by emphasizing sustained benefit and efficacy in conjunction with tolerability, in contrast to outcomes based on single point in time assessment. The controlled design allows causal inference and eliminates unmeasured confounders associated with nonrandomized treatment decisions.

KW - Bipolar

KW - Clinical trials

KW - Effectiveness

KW - Generalizability

KW - Methodologies

KW - Randomized

UR - http://www.scopus.com/inward/record.url?scp=84942905739&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84942905739&partnerID=8YFLogxK

U2 - 10.1016/B978-0-12-405170-6.00007-5

DO - 10.1016/B978-0-12-405170-6.00007-5

M3 - Chapter

SN - 9780124051768

SN - 9780124051706

SP - 75

EP - 86

BT - Clinical Trial Design Challenges in Mood Disorders

PB - Elsevier Inc.

ER -