Early phase clinical trials extension to guidelines for the content of statistical analysis plans

被引：14

作者：

Homer, Victoria ^{[1
]}

Yap, Christina ^{[2
]}

Bond, Simon ^{[3
]}

Holmes, Jane ^{[4
]}

Stocken, Deborah ^{[5
]}

Walker, Katrina ^{[5
]}

Robinson, Emily J. ^{[6
]}

Wheeler, Graham ^{[7
]}

Brown, Sarah ^{[5
]}

Hinsley, Samantha ^{[8
]}

Schipper, Matthew ^{[9
,10
]}

Weir, Christopher J. ^{[11
]}

Rantell, Khadija ^{[12
]}

Prior, Thomas ^{[13
]}

Yu, Ly-Mee ^{[14
]}

Kirkpatrick, John ^{[15
]}

Bedding, Alun ^{[15
]}

Gamble, Carrol ^{[16
]}

Gaunt, Piers ^{[1
]}

机构：

[1] Univ Birmingham, Canc Res Clin Trials Unit, Birmingham, W Midlands, England

[2] Inst Canc Res, Clin Trials & Stat Unit, London, England

[3] Cambridge Clin Trials Unit, Cambridge, England

[4] Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford Clin Trials Res Unit, Oxford, England

[5] Univ Leeds, Leeds Inst Clin Trials Res, Clin Trials Res Unit, Leeds, W Yorkshire, England

[6] Royal Marsden NHS Fdn Trust, Royal Marsden Clin Trials Unit, London, England

[7] Imperial Coll London, Imperial Clin Trials Unit, London, England

[8] Univ Glasgow, Canc Res UK Glasgow Clin Trials Unit, Glasgow, Lanark, Scotland

[9] Univ Michigan, Dept Radiat Oncol, Ann Arbor, MI 48109 USA

[10] Univ Michigan, Dept Biostat, Ann Arbor, MI 48109 USA

[11] Univ Edinburgh, Usher Inst, Edinburgh Clin Trials Unit, Edinburgh, Midlothian, Scotland

[12] Med & Healthcare Prod Regulatory Agcy, London, England

[13] Janssen Res & Dev, Early Dev Oncol Stat Dept, Spring House, PA USA

[14] Univ Oxford, Primary Care Clin Trials Unit, Oxford, England

[15] Roche Prod, Welwyn Garden City, Herts, England

[16] Univ Liverpool, Liverpool Clin Trials Ctr, Liverpool, Merseyside, England

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2022年 / 376卷

基金：

“创新英国”项目;

关键词：

CONTINUAL REASSESSMENT METHOD; DOSE-ESCALATION; DESIGNS;

D O I：

10.1136/bmj-2021-068177

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.

引用

页数：10

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