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Editorial
. 2019 Apr 1;30(4):506-509.
doi: 10.1093/annonc/mdz038.

On the need to adjust for multiplicity in confirmatory clinical trials with master protocols

N Stallard  1 , S Todd  2 , D Parashar  3 , P K Kimani  4 , L A Renfro  5
Affiliations
Editorial

On the need to adjust for multiplicity in confirmatory clinical trials with master protocols

N Stallard et al. Ann Oncol. .
No abstract available

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Figures

Figure 1.
Figure 1.
Designs for clinical trials with master protocols: (A) with subgroups within treatment arms; (B) with treatment arms within subgroups; (C) with subgroups within treatment arms within subgroups.
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References

    1. Food and Drug Administration. Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. Draft Guidance for Industry. Rockville, MD: Food and Drug Administration; 2018.
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    1. Howard DR, Brown JM, Todd S, Gregory WM.. Recommendations on multiple adjustment in multi-arm trials with a shared control group. Stat Methods Med Res 2018; 27(5): 1513–1530. - PubMed
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    1. Kim ES, Hirsh V, Mok T. et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomized phase III trial. Lancet 2008; 372(9652): 1809–1818. - PubMed

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