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The International Journal of Biostatistics

Ed. by Chambaz, Antoine / Hubbard, Alan E. / van der Laan, Mark J.


IMPACT FACTOR 2018: 1.309

CiteScore 2018: 1.11

SCImago Journal Rank (SJR) 2018: 1.325
Source Normalized Impact per Paper (SNIP) 2018: 0.715

Mathematical Citation Quotient (MCQ) 2018: 0.03

Online
ISSN
1557-4679
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Systematic Missing-At-Random (SMAR) Design and Analysis for Translational Research Studies

Ilana Belitskaya-Levy / Yongzhao Shao / Judith D Goldberg
Published Online: 2008-07-30 | DOI: https://doi.org/10.2202/1557-4679.1046

Translational research studies often involve a central study (e.g. clinical trial, cohort of patients, etc.) and multiple investigators who are each interested in addressing different research questions using the same patient population. However, it is often impossible for the investigators to include all patients in all of the ancillary translational research substudies that are part of the main study. This arises due to time and budgetary constraints and other logistical considerations. In this paper, we propose a prospective Systematic Missing-At-Random study design (SMAR) with planned partially missing covariates collected using a nested random sampling scheme that allows an integrated statistical analysis across all domains of data. We propose an algorithm for data analysis that incorporates the features of the design. We show that the SMAR design is computationally and statistically efficient as well as cost effective using simulation studies and a published data example. An extension to a two-stage prospective-retrospective design is discussed.

Keywords: study design; translational research; prospective design; monotone missing pattern; nested random sampling; EM algorithm; outcome-dependent sampling; clinical trial design

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Published Online: 2008-07-30


Citation Information: The International Journal of Biostatistics, Volume 4, Issue 1, ISSN (Online) 1557-4679, DOI: https://doi.org/10.2202/1557-4679.1046.

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