Subject adherence: are the subjects following the protocol? If not, how to assess and analyze (intention to treat vs. per protocol)

Gonca Ozcan; Meghana Singh; Eric M. Mortensen

doi:10.1016/B978-0-323-88423-5.00069-8

Subject adherence: are the subjects following the protocol? If not, how to assess and analyze (intention to treat vs. per protocol)

Gonca Ozcan, Meghana Singh, Eric M. Mortensen

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

Subject adherence is a key component of any clinical trial. Poor adherence to interventions in clinical trials may impair the trials' value, for example, by jeopardizing estimates of a treatment's benefits and dangers. In this chapter, we discussed the effect of poor subject adherence in clinical studies, its importance, methods to assess adherence, strategies to mitigate non-adherence, and analysis strategies. We also discussed different methods of analysis, including intention to treat and per protocol.

Original language	English (US)
Title of host publication	Translational Radiation Oncology
Publisher	Elsevier
Pages	437-443
Number of pages	7
ISBN (Electronic)	9780323884235
ISBN (Print)	9780323884242
DOIs	https://doi.org/10.1016/B978-0-323-88423-5.00069-8
State	Published - Jan 1 2023
Externally published	Yes

Keywords

Bias
Clinical trial
Intention-to-treat analysis
Per-protocol analysis
Subject adherence

ASJC Scopus subject areas

General Agricultural and Biological Sciences
General Biochemistry, Genetics and Molecular Biology

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10.1016/B978-0-323-88423-5.00069-8

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AU - Mortensen, Eric M.

PY - 2023/1/1

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AB - Subject adherence is a key component of any clinical trial. Poor adherence to interventions in clinical trials may impair the trials' value, for example, by jeopardizing estimates of a treatment's benefits and dangers. In this chapter, we discussed the effect of poor subject adherence in clinical studies, its importance, methods to assess adherence, strategies to mitigate non-adherence, and analysis strategies. We also discussed different methods of analysis, including intention to treat and per protocol.

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KW - Intention-to-treat analysis

KW - Per-protocol analysis

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BT - Translational Radiation Oncology

PB - Elsevier

ER -

Subject adherence: are the subjects following the protocol? If not, how to assess and analyze (intention to treat vs. per protocol)

Abstract

Keywords

ASJC Scopus subject areas

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