NEOMED Library: Journal Club Presentation Resources (Statistics Help): ITT, Per Protocol, etc. / Non-inferiority Trials, etc.

Intention to Treat & Per Protocol / LOCF

Intent-to-treat Analysis of Randomized Clinical Trials
Michael P. LaValley - Boston University
Intention-to-treat Analysis
The CONSORT Group
Intention-to-treat Definition
The CONSORT Group
Intention-to-treat and Per-protocol Analysis
Shah PB. Intention-to-treat and per-protocol analysis. CMAJ : Canadian Medical Association Journal. 2011;183(6):696. doi:10.1503/cmaj.111-2033.
What is Intention to Treat Analysis?
Sedgwick P. 2013. Sample size: how many participants are needed in a trial? BMJ. 2013;346:f3662.
Intention-to-treat Analysis: What Is It and Why Is It Important?
YouTube video by Terry Shaneyfelt, M.D.
Intention-to-treat Concept: A Review (also discusses mITT)
Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011;2(3):109-12.
Intention-to-treat and Modified Intention-to-treat
Cochrane Handbook
Per Protocol Analysis
Sedgwick P. Per protocol analysis. BMJ 2010;340:c1825.
What is Per Protocol Analysis?
Sedgwick P. What is per protocol analysis? BMJ. 2013;346:f3748.
Modified Versus Standard Intention-to-treat Reporting: Are There Differences in Methodological Quality, Sponsorship, and Findings in Randomized Trials? A Cross-sectional Study.
Montedori A, Bonacini MI, Casazza G, et al. Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study. Trials. 2011;12:58.
Last Observation Carried Forward (LOCF)
See section on missing values
LOCF, BOCF, WOCF, and MVTF
On Biostatistics and Clinical Trials Blog - Dr. Deng
Does Analysis Using "Last Observation Carried Forward" Introduce Bias in Dementia Research?
Molnar F, Hutton B, Fergusson D. Does analysis using "last observation carried forward" introduce bias in dementia research? CMAJ. 2008;179(8):751-3.
A Closer Look at the Baseline-Observation-Carried-Forward (BOCF)
Liu-seifert H, Zhang S, D'souza D, Skljarevski V. A closer look at the baseline-observation-carried-forward (BOCF). Patient Prefer Adherence. 2010;4:11-6.
Is MMRM Good Enough in Handling the Missing Data in Longitudinal Clinical Trials?
On Biostatistics and Clinical Trials Blog - Dr. Deng
Clinical Trial Design Issues: At Least 10 Things You Should Look for in Clinical Trials
Glasser SP, Howard G. Clinical trial design issues: at least 10 things you should look for in clinical trials. J Clin Pharmacol. 2006;46(10):1106-15.
Sketchy EBM
Animations about EBM topics
Intention-to-Treat Concept: A Review
Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109-112. Article available via PubMed Central
Lost (To Follow-up) You Tube Video
Sketchy EBM
Intention-to-Treat Analyses and Missing Data Approaches in Pharmacotherapy Trials for Alcohol Use Disorders
Del Re AC, Maisel NC, Blodgett JC, Finney JW. Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders. BMJ Open. 2013;3(11):e003464.
Intention to Treat Tutorial Video
Sketchy EBM
Intention-to-treat Analysis: What Is It and Why Is It Important? Tutorial Video
by Terry Shaneyfelt, M.D.
Intention-to-Treat Analysis (ITT Analysis)
PubMed Health
Per-Protocol Analysis
PubMed Health
Intention-to-treat and Transparency of Related Practices in Randomized, Controlled Trials of Anti-infectives
Beckett RD, Loeser KC, Bowman KR, Towne TG. Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives. BMC Med Res Methodol. 2016;16(1):106. (Definitions for ITT, mITT, and PP can be found in table 1).

Superiority, Equivalence, & Non-Inferiority Trials

Equivalence Trials
Sedgwick P. 2013. Equivalence trials. BMJ. 2013;346:f184.
Lessons From and Cautions About Noninferiority and Equivalence Randomized Trials
Gøtzsche PC. Lessons from and cautions about noninferiority and equivalence randomized trials. JAMA. 2006;295(10):1172-4.
Non-inferiority Trials
Sedgwick P. Non-inferiority trials. 2011. BMJ. 342:d3253
Noninferiority Trials
Snapinn SM. Noninferiority trials. Curr Control Trials Cardiovasc Med. 2000;1(1):19-21.
The Pros and Cons of Noninferiority Trials
Pocock SJ. The pros and cons of noninferiority trials. Fundam Clin Pharmacol. 2003;17(4):483-90.
Superiority, Equivalence, and Non-Inferiority Trials
Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):150-4.
Superiority, Non-inferiority, Equivalence Studies - What is the Difference?
Superiority Trials, Non-inferiority Trials, and Prisoners of the 2-sided Null Hypothesis
Sackett DL. Superiority trials, noninferiority trials, and prisoners of the 2-sided null hypothesis. Evid Based Med 2004;9:38-39.
Points to Consider on Switching Between Superiority and Non-inferiority.
Committee for Proprietary Medicinal Products (CPMP). Points to consider on switching between superiority and non-inferiority. British Journal of Clinical Pharmacology 2001;52(3):223-228. Article available in PubMed Central.
Clinical Trial Design Issues: At Least 10 Things You Should Look for in Clinical Trials
Glasser SP, Howard G. Clinical trial design issues: at least 10 things you should look for in clinical trials. J Clin Pharmacol. 2006;46(10):1106-15.

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Journal Club Presentation Resources (Statistics Help): ITT, Per Protocol, etc. / Non-inferiority Trials, etc.

Intention to Treat & Per Protocol / LOCF

Superiority, Equivalence, & Non-Inferiority Trials