Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Matthew R Sydes; Mahesh K B Parmar; Malcolm D Mason; Noel W Clarke; Claire Amos; John Anderson; Johann de Bono; David P Dearnaley; John Dwyer; Charlene Green; Gordana Jovic; Alastair W S Ritchie; J Martin Russell; Karen Sanders; George Thalmann; Nicholas D James

doi:10.1186/1745-6215-13-168

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Matthew R Sydes
, Mahesh K B Parmar
, Malcolm D Mason
, Noel W Clarke
, Claire Amos
, John Anderson
, Johann de Bono
, David P Dearnaley
, John Dwyer
, Charlene Green
, Gordana Jovic
, Alastair W S Ritchie
, J Martin Russell
, Karen Sanders
, George Thalmann
, Nicholas D James

Cancer and Genomic Sciences

Research output: Contribution to journal › Article › peer-review

86 Citations (Scopus)

Abstract

Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial.

Original language	English
Pages (from-to)	168
Journal	Trials
Volume	13
DOIs	https://doi.org/10.1186/1745-6215-13-168
Publication status	Published - 2012

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1186/1745-6215-13-168

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Sydes, M. R., Parmar, M. K. B., Mason, M. D., Clarke, N. W., Amos, C., Anderson, J., de Bono, J., Dearnaley, D. P., Dwyer, J., Green, C., Jovic, G., Ritchie, A. W. S., Russell, J. M., Sanders, K., Thalmann, G., & James, N. D. (2012). Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials, 13, 168. https://doi.org/10.1186/1745-6215-13-168

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title = "Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial",

abstract = "Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial.",

author = "Sydes, \{Matthew R\} and Parmar, \{Mahesh K B\} and Mason, \{Malcolm D\} and Clarke, \{Noel W\} and Claire Amos and John Anderson and \{de Bono\}, Johann and Dearnaley, \{David P\} and John Dwyer and Charlene Green and Gordana Jovic and Ritchie, \{Alastair W S\} and Russell, \{J Martin\} and Karen Sanders and George Thalmann and James, \{Nicholas D\}",

year = "2012",

doi = "10.1186/1745-6215-13-168",

language = "English",

volume = "13",

pages = "168",

journal = "Trials",

publisher = "Springer",

}

Sydes, MR, Parmar, MKB, Mason, MD, Clarke, NW, Amos, C, Anderson, J, de Bono, J, Dearnaley, DP, Dwyer, J, Green, C, Jovic, G, Ritchie, AWS, Russell, JM, Sanders, K, Thalmann, G & James, ND 2012, 'Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial', Trials, vol. 13, pp. 168. https://doi.org/10.1186/1745-6215-13-168

TY - JOUR

T1 - Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE

T2 - a multi-arm multi-stage randomized controlled trial

AU - Sydes, Matthew R

AU - Parmar, Mahesh K B

AU - Mason, Malcolm D

AU - Clarke, Noel W

AU - Amos, Claire

AU - Anderson, John

AU - de Bono, Johann

AU - Dearnaley, David P

AU - Dwyer, John

AU - Green, Charlene

AU - Jovic, Gordana

AU - Ritchie, Alastair W S

AU - Russell, J Martin

AU - Sanders, Karen

AU - Thalmann, George

AU - James, Nicholas D

PY - 2012

Y1 - 2012

N2 - Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial.

AB - Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial.

U2 - 10.1186/1745-6215-13-168

DO - 10.1186/1745-6215-13-168

M3 - Article

C2 - 22978443

VL - 13

SP - 168

JO - Trials

JF - Trials

ER -

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Abstract

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