Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)

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References

NIH Pragmatic Trials Collaboratory. Rethinking clinical trials, https://rethinkingclinicaltrials.org/ (Updated 2021; accessed 1 September 2021).

Lokhnygina

Murray

, et al. An evaluation of constrained randomization for the design and analysis of group-randomized trials. Stat Med 2016; 35(10): 1565–1579.

Turner

Heagerty

, et al. An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes. Stat Med 2017; 36(24): 3791–3806.

Hughes

Hemming

, et al. Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview. Stat Methods Med Res 2021; 30(2): 612–639.

Cook

Delong

Murray

, et al. Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials 2016; 13(5): 504–512.

Yang

Starks

, et al. Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials. Stat Med 2020; 39(28): 4218–4237.

. Design and analysis considerations for cohort stepped wedge cluster randomized trials with a decay correlation structure. Stat Med 2020; 39(4): 438–455.

Moulton

O'Brien

Kohberger

, et al. Design of a group-randomized Streptococcus pneumoniae vaccine trial. Control Clin Trials 2001; 22(4): 438–452.

Hemming

Taljaard

Moerbeek

, et al. Contamination: how much can an individually randomized trial tolerate? Stat Med 2021; 40(14): 3329–3351.

10.

Quartagno

Grund

Carpenter

. jomo: a flexible package for two-level joint modelling multiple imputation. R Journal 2019; 11(2): 205–228.

11.

Teerenstra

Moerbeek

van Achterberg

, et al. Sample size calculations for 3-level cluster randomized trials. Clin Trials 2008; 5(5): 486–495.

12.

Kerry

Bland

. Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med 2001; 20(3): 377–390.

13.

Eldridge

Ashby

Kerry

. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol 2006; 35(5): 1292–1300.

14.

World Health Organization. An R&D blueprint for action to prevent epidemics—plan of action May 2016, https://www.who.int/publications/m/item/an-r-d-blueprint-for-action-to-prevent-epidemics (2016, accessed 2 September 2021).

15.

Murray

. Influential methods reports for group-randomized trials and related designs. Clin Trials. Epub ahead of print 6 January 2022. DOI: 10.1177/17407745211063423.