An overview of practical approaches for handling missing data in clinical trials

CM DeSouza, ATR Legedza… - Journal of …, 2009 - Taylor & Francis
For a variety of reasons including poorly designed case report forms (CRFs), incomplete or
invalid CRF data entries, and premature treatment or study discontinuations, missing data is …

Handling missing data in clinical trials: an overview

WR Myers - Drug information journal: DIJ/Drug Information …, 2000 - Springer
A major problem in the analysis of clinical trials is missing data caused by patients dropping
out of the study before completion. This problem can result in biased treatment comparisons …

Review of guidelines and literature for handling missing data in longitudinal clinical trials with a case study

M Liu, L Wei, J Zhang - … : The Journal of Applied Statistics in the …, 2006 - Wiley Online Library
Missing data in clinical trials are inevitable. We highlight the ICH guidelines and CPMP
points to consider on missing data. Specifically, we outline how we should consider missing …

MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets

O Siddiqui, HMJ Hung, R O'Neill - Journal of biopharmaceutical …, 2009 - Taylor & Francis
In recent years, the use of the last observation carried forward (LOCF) approach in imputing
missing data in clinical trials has been greatly criticized, and several likelihood-based …

Choice of the primary analysis in longitudinal clinical trials

CH Mallinckrodt, JG Watkin… - … : The Journal of …, 2004 - Wiley Online Library
Missing data, and the bias they can cause, are an almost ever‐present concern in clinical
trials. The last observation carried forward (LOCF) approach has been frequently utilized to …

Missing data handling methods in medical device clinical trials

X Yan, S Lee, N Li - Journal of Biopharmaceutical Statistics, 2009 - Taylor & Francis
One of the major problems in the analysis of clinical trials is missing data caused by patients
dropping out before study completion. The issue of missing data can result in biased …

Handling drop‐out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches

P Lane - Pharmaceutical Statistics: The Journal of Applied …, 2008 - Wiley Online Library
This study compares two methods for handling missing data in longitudinal trials: one using
the last‐observation‐carried‐forward (LOCF) method and one based on a multivariate or …

A regulatory perspective on missing data in the aftermath of the NRC report

LM LaVange, T Permutt - Statistics in medicine, 2016 - Wiley Online Library
The issuance of a report in 2010 by the National Research Council (NRC) of the National
Academy of Sciences entitled 'The Prevention and Treatment of Missing Data in Clinical …

[HTML][HTML] A mixed model approach for intent-to-treat analysis in longitudinal clinical trials with missing values

H Chakraborty, H Gu - 2009 - books.google.com
Missing values and dropouts are common issues in longitudinal studies in all areas of
medicine and public health. Intent-to-treat (ITT) analysis has become a widely accepted …

A comparison of the random-effects pattern mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts

O Siddiqui, MW Ali - Journal of biopharmaceutical statistics, 1998 - Taylor & Francis
The last-observation-carried-forward imputation method is commonly used for imputing data
missing due to dropouts in longitudinal clinical trials. The method assumes that outcome …