Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply

Michael Weller; Nicholas Butowski; David D. Tran; Lawrence D. Recht; Michael Lim; Hal Hirte; Lynn Ashby; Laszlo Mechtler; Samuel A. Goldlust; Fabio Iwamoto; Jan Drappatz; Donald M. O'Rourke; Mark Wong; Mark G. Hamilton; Gaetano Finocchiaro; James Perry; Wolfgang Wick; Jennifer Green; Yi He; Christopher D. Turner; Michael J. Yellin; Tibor Keler; Thomas A. Davis; Roger Stupp; John H. Sampson

doi:10.1016/S1470-2045(17)30856-2

Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply

Michael Weller, Nicholas Butowski, David D. Tran, Lawrence D. Recht, Michael Lim, Hal Hirte, Lynn Ashby, Laszlo Mechtler, Samuel A. Goldlust, Fabio Iwamoto, Jan Drappatz, Donald M. O'Rourke, Mark Wong, Mark G. Hamilton, Gaetano Finocchiaro, James Perry, Wolfgang Wick, Jennifer Green, Yi He, Christopher D. TurnerMichael J. Yellin, Tibor Keler, Thomas A. Davis, Roger Stupp, John H. Sampson

Neurological Surgery

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

4 Scopus citations

Original language	English (US)
Pages (from-to)	e709-e710
Journal	The Lancet Oncology
Volume	18
Issue number	12
DOIs	https://doi.org/10.1016/S1470-2045(17)30856-2
State	Published - Dec 2017

ASJC Scopus subject areas

Oncology

Access to Document

10.1016/S1470-2045(17)30856-2

Cite this

Weller, M., Butowski, N., Tran, D. D., Recht, L. D., Lim, M., Hirte, H., Ashby, L., Mechtler, L., Goldlust, S. A., Iwamoto, F., Drappatz, J., O'Rourke, D. M., Wong, M., Hamilton, M. G., Finocchiaro, G., Perry, J., Wick, W., Green, J., He, Y., ... Sampson, J. H. (2017). Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply. The Lancet Oncology, 18(12), e709-e710. https://doi.org/10.1016/S1470-2045(17)30856-2

Weller, Michael ; Butowski, Nicholas ; Tran, David D. ; Recht, Lawrence D. ; Lim, Michael ; Hirte, Hal ; Ashby, Lynn ; Mechtler, Laszlo ; Goldlust, Samuel A. ; Iwamoto, Fabio ; Drappatz, Jan ; O'Rourke, Donald M. ; Wong, Mark ; Hamilton, Mark G. ; Finocchiaro, Gaetano ; Perry, James ; Wick, Wolfgang ; Green, Jennifer ; He, Yi ; Turner, Christopher D. ; Yellin, Michael J. ; Keler, Tibor ; Davis, Thomas A. ; Stupp, Roger ; Sampson, John H. / Go, no-go decision making for phase 3 clinical trials : ACT IV revisited – Authors' reply. In: The Lancet Oncology. 2017 ; Vol. 18, No. 12. pp. e709-e710.

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title = "Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply",

author = "Michael Weller and Nicholas Butowski and Tran, {David D.} and Recht, {Lawrence D.} and Michael Lim and Hal Hirte and Lynn Ashby and Laszlo Mechtler and Goldlust, {Samuel A.} and Fabio Iwamoto and Jan Drappatz and O'Rourke, {Donald M.} and Mark Wong and Hamilton, {Mark G.} and Gaetano Finocchiaro and James Perry and Wolfgang Wick and Jennifer Green and Yi He and Turner, {Christopher D.} and Yellin, {Michael J.} and Tibor Keler and Davis, {Thomas A.} and Roger Stupp and Sampson, {John H.}",

note = "Funding Information: MW reports grants and personal fees from Roche, Merck, Actelion, and Novocure; personal fees from MSD, Pfizer, Tocagen, Celldex, Magforce, Bristol-Myers Squibb; and grants from OGD2, Acceleron, and Bayer, outside the submitted work. DDT reports grants from Merck, Novartis, NWBio, Celldex, Stemline, VBL, and TVax; grants and personal fees from Novocure; personal fees from Monteris; and non-financial support from Corvidia, outside the submitted work. ML reports grants from Celldex, during the conduct of the study; grants from Regeneron; grants and personal fees from BMS and Agenus; and personal fees from Merck, Oncorus, Boston Biomedical, Stryker, and Baxter, outside the submitted work. SAG reports personal fees, non-financial support, and is a consultant and on the speaker's bureau and advisory board from Novocure; personal fees and non-financial support from Wex and Bristol-Myers Squibb; and personal fees from Cortice Biosciences, outside the submitted work. FI reports clinical trial costs from Celldex, during the conduct of the study; grants and personal fees from Merck and Novocure; and personal fees from Bristol Myers Squibb, Prime Oncology, Regeneron, AbbVie, and Alexion, outside the submitted work. DMO'R reports grants from Celldex Therapeutics, Inc, outside the submitted work and has issued patents. MW reports clinical trial costs from Celldex Therapeutics, Inc, during the conduct of the study. MGH reports personal fees from Celldex Therapeutics, Inc, during the conduct of the study. GF reports personal fees from BMS, outside the submitted work. WW reports grants and personal fees from MSD, grants and personal fees from Roche and BMS, outside the submitted work. JG, YH, CDT, MJY, TK, and TAD report personal fees, salary, and equity from Celldex Therapeutics, during the conduct of the study. RS reports fees (to institution) from MSD-Merck & Co, Roche/Genentech, Novartis, Merck KGaA, Darmstadt, AbbVie, and AstraZeneca, outside the submitted work; non-financial support from Novocure Ltd; and their spouse is a full-time employee of Celgene and has equity in Celgene. JHS reports stock from Istari Oncology; stock from Annais; personal fees from Bristol-Myers Squibb; personal fees and consulting and stock options from Immunomic Therapeutics; and patents with royalties paid. NB, LDR, HH, LA, LM, JD, and JP declare no competing interests.",

year = "2017",

month = dec,

doi = "10.1016/S1470-2045(17)30856-2",

language = "English (US)",

volume = "18",

pages = "e709--e710",

journal = "The Lancet Oncology",

issn = "1470-2045",

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Weller, M, Butowski, N, Tran, DD, Recht, LD, Lim, M, Hirte, H, Ashby, L, Mechtler, L, Goldlust, SA, Iwamoto, F, Drappatz, J, O'Rourke, DM, Wong, M, Hamilton, MG, Finocchiaro, G, Perry, J, Wick, W, Green, J, He, Y, Turner, CD, Yellin, MJ, Keler, T, Davis, TA, Stupp, R & Sampson, JH 2017, 'Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply', The Lancet Oncology, vol. 18, no. 12, pp. e709-e710. https://doi.org/10.1016/S1470-2045(17)30856-2

Go, no-go decision making for phase 3 clinical trials : ACT IV revisited – Authors' reply. / Weller, Michael; Butowski, Nicholas; Tran, David D.; Recht, Lawrence D.; Lim, Michael; Hirte, Hal; Ashby, Lynn; Mechtler, Laszlo; Goldlust, Samuel A.; Iwamoto, Fabio; Drappatz, Jan; O'Rourke, Donald M.; Wong, Mark; Hamilton, Mark G.; Finocchiaro, Gaetano; Perry, James; Wick, Wolfgang; Green, Jennifer; He, Yi; Turner, Christopher D.; Yellin, Michael J.; Keler, Tibor; Davis, Thomas A.; Stupp, Roger; Sampson, John H.

In: The Lancet Oncology, Vol. 18, No. 12, 12.2017, p. e709-e710.

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

TY - JOUR

T1 - Go, no-go decision making for phase 3 clinical trials

T2 - ACT IV revisited – Authors' reply

AU - Weller, Michael

AU - Butowski, Nicholas

AU - Tran, David D.

AU - Recht, Lawrence D.

AU - Lim, Michael

AU - Hirte, Hal

AU - Ashby, Lynn

AU - Mechtler, Laszlo

AU - Goldlust, Samuel A.

AU - Iwamoto, Fabio

AU - Drappatz, Jan

AU - O'Rourke, Donald M.

AU - Wong, Mark

AU - Hamilton, Mark G.

AU - Finocchiaro, Gaetano

AU - Perry, James

AU - Wick, Wolfgang

AU - Green, Jennifer

AU - He, Yi

AU - Turner, Christopher D.

AU - Yellin, Michael J.

AU - Keler, Tibor

AU - Davis, Thomas A.

AU - Stupp, Roger

AU - Sampson, John H.

N1 - Funding Information: MW reports grants and personal fees from Roche, Merck, Actelion, and Novocure; personal fees from MSD, Pfizer, Tocagen, Celldex, Magforce, Bristol-Myers Squibb; and grants from OGD2, Acceleron, and Bayer, outside the submitted work. DDT reports grants from Merck, Novartis, NWBio, Celldex, Stemline, VBL, and TVax; grants and personal fees from Novocure; personal fees from Monteris; and non-financial support from Corvidia, outside the submitted work. ML reports grants from Celldex, during the conduct of the study; grants from Regeneron; grants and personal fees from BMS and Agenus; and personal fees from Merck, Oncorus, Boston Biomedical, Stryker, and Baxter, outside the submitted work. SAG reports personal fees, non-financial support, and is a consultant and on the speaker's bureau and advisory board from Novocure; personal fees and non-financial support from Wex and Bristol-Myers Squibb; and personal fees from Cortice Biosciences, outside the submitted work. FI reports clinical trial costs from Celldex, during the conduct of the study; grants and personal fees from Merck and Novocure; and personal fees from Bristol Myers Squibb, Prime Oncology, Regeneron, AbbVie, and Alexion, outside the submitted work. DMO'R reports grants from Celldex Therapeutics, Inc, outside the submitted work and has issued patents. MW reports clinical trial costs from Celldex Therapeutics, Inc, during the conduct of the study. MGH reports personal fees from Celldex Therapeutics, Inc, during the conduct of the study. GF reports personal fees from BMS, outside the submitted work. WW reports grants and personal fees from MSD, grants and personal fees from Roche and BMS, outside the submitted work. JG, YH, CDT, MJY, TK, and TAD report personal fees, salary, and equity from Celldex Therapeutics, during the conduct of the study. RS reports fees (to institution) from MSD-Merck & Co, Roche/Genentech, Novartis, Merck KGaA, Darmstadt, AbbVie, and AstraZeneca, outside the submitted work; non-financial support from Novocure Ltd; and their spouse is a full-time employee of Celgene and has equity in Celgene. JHS reports stock from Istari Oncology; stock from Annais; personal fees from Bristol-Myers Squibb; personal fees and consulting and stock options from Immunomic Therapeutics; and patents with royalties paid. NB, LDR, HH, LA, LM, JD, and JP declare no competing interests.

PY - 2017/12

Y1 - 2017/12

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U2 - 10.1016/S1470-2045(17)30856-2

DO - 10.1016/S1470-2045(17)30856-2

M3 - Letter

C2 - 29208433

AN - SCOPUS:85035348037

VL - 18

SP - e709-e710

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

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