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)

Access to Document

10.1186/1745-6215-13-168

Cite this

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

@article{d91f2c912d374192a7190497ef8fded6,

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

UN SDGs

Access to Document

Fingerprint

Cite this