Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

Overview

Journal Stat Biopharm Res

Date 2021 Jun 30

PMID 34191971

Citations 44

Authors

R Daniel Meyer

Bohdana Ratitch

Marcel Wolbers

Olga Marchenko

Hui Quan

Daniel Li

Christine Fletcher

Xin Li

David Wright

Yue Shentu

Stefan Englert

Wei Shen

Jyotirmoy Dey

Thomas Liu

Ming Zhou

Norman Bohidar

Peng-Liang Zhao

Michael Hale

Affiliations

Soon will be listed here.

Abstract

Citing Articles

Statistical methods for clinical trials interrupted by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic: A review.

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Evaluation of adapted parent training for challenging behaviour in pre-school children with moderate to severe intellectual developmental disabilities: A randomised controlled trial.

Royston R, Absoud M, Ambler G, Barnes J, Hunter R, Kyriakopoulos M PLoS One. 2024; 19(8):e0306182.

PMID: 39137195 PMC: 11321573. DOI: 10.1371/journal.pone.0306182.

Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.

Ondruskova T, Royston R, Absoud M, Ambler G, Qu C, Barnes J Health Technol Assess. 2024; 28(6):1-94.

PMID: 38329108 PMC: 11017145. DOI: 10.3310/JKTY6144.

Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study.

Wang M, Siddiqi T, Gordon L, Kamdar M, Lunning M, Hirayama A J Clin Oncol. 2023; 42(10):1146-1157.

PMID: 38072625 PMC: 11741176. DOI: 10.1200/JCO.23.02214.

A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial.

Lombardo F, Spila Alegiani S, Mayer F, Cipriani M, Lo Giudice M, Ludolph A Trials. 2023; 24(1):792.

PMID: 38053196 PMC: 10696667. DOI: 10.1186/s13063-023-07638-w.

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