Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

Eudocia Q. Lee; Eudocia Q. Lee; Michael Weller; Joohee Sul; Stephen J. Bagley; Solmaz Sahebjam; Martin Van Den Bent; Manmeet Ahluwalia; Jian L. Campian; Evanthia Galanis; Mark R. Gilbert; Matthias Holdhoff; Glenn J. Lesser; Frank S. Lieberman; Minesh P. Mehta; Marta Penas-Prado; Karisa C. Schreck; Roy E. Strowd; Michael A. Vogelbaum; Tobias Walbert; Susan M. Chang; L. Burt Nabors; Stuart Grossman; David A. Reardon; David A. Reardon; Patrick Y. Wen; Patrick Y. Wen

doi:10.1093/neuonc/noaa015

Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

Eudocia Q. Lee, Eudocia Q. Lee, Michael Weller, Joohee Sul, Stephen J. Bagley, Solmaz Sahebjam, Martin Van Den Bent, Manmeet Ahluwalia, Jian L. Campian, Evanthia Galanis, Mark R. Gilbert, Matthias Holdhoff, Glenn J. Lesser, Frank S. Lieberman, Minesh P. Mehta, Marta Penas-Prado, Karisa C. Schreck, Roy E. Strowd, Michael A. Vogelbaum, Tobias WalbertSusan M. Chang, L. Burt Nabors, Stuart Grossman, David A. Reardon, David A. Reardon, Patrick Y. Wen, Patrick Y. Wen

Research output: Contribution to journal › Review article › peer-review

8 Scopus citations

Abstract

Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

Original language	English
Pages (from-to)	601-612
Number of pages	12
Journal	Neuro-oncology
Volume	22
Issue number	5
DOIs	https://doi.org/10.1093/neuonc/noaa015
State	Published - May 15 2020

Keywords

clinical trials
eligibility
exclusion criteria
inclusion criteria
primary brain tumor

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10.1093/neuonc/noaa015

Cite this

Lee, E. Q., Lee, E. Q., Weller, M., Sul, J., Bagley, S. J., Sahebjam, S., Van Den Bent, M., Ahluwalia, M., Campian, J. L., Galanis, E., Gilbert, M. R., Holdhoff, M., Lesser, G. J., Lieberman, F. S., Mehta, M. P., Penas-Prado, M., Schreck, K. C., Strowd, R. E., Vogelbaum, M. A., ... Wen, P. Y. (2020). Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. Neuro-oncology, 22(5), 601-612. https://doi.org/10.1093/neuonc/noaa015

Lee, Eudocia Q. ; Lee, Eudocia Q. ; Weller, Michael ; Sul, Joohee ; Bagley, Stephen J. ; Sahebjam, Solmaz ; Van Den Bent, Martin ; Ahluwalia, Manmeet ; Campian, Jian L. ; Galanis, Evanthia ; Gilbert, Mark R. ; Holdhoff, Matthias ; Lesser, Glenn J. ; Lieberman, Frank S. ; Mehta, Minesh P. ; Penas-Prado, Marta ; Schreck, Karisa C. ; Strowd, Roy E. ; Vogelbaum, Michael A. ; Walbert, Tobias ; Chang, Susan M. ; Nabors, L. Burt ; Grossman, Stuart ; Reardon, David A. ; Reardon, David A. ; Wen, Patrick Y. ; Wen, Patrick Y. / Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. In: Neuro-oncology. 2020 ; Vol. 22, No. 5. pp. 601-612.

@article{213e26d0a9374182b575694ec5201593,

title = "Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients",

abstract = "Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials. ",

keywords = "clinical trials, eligibility, exclusion criteria, inclusion criteria, primary brain tumor",

author = "Lee, {Eudocia Q.} and Lee, {Eudocia Q.} and Michael Weller and Joohee Sul and Bagley, {Stephen J.} and Solmaz Sahebjam and {Van Den Bent}, Martin and Manmeet Ahluwalia and Campian, {Jian L.} and Evanthia Galanis and Gilbert, {Mark R.} and Matthias Holdhoff and Lesser, {Glenn J.} and Lieberman, {Frank S.} and Mehta, {Minesh P.} and Marta Penas-Prado and Schreck, {Karisa C.} and Strowd, {Roy E.} and Vogelbaum, {Michael A.} and Tobias Walbert and Chang, {Susan M.} and Nabors, {L. Burt} and Stuart Grossman and Reardon, {David A.} and Reardon, {David A.} and Wen, {Patrick Y.} and Wen, {Patrick Y.}",

note = "Funding Information: This work was supported by the Adult Brain Tumor Consortium (ABTC) NIH/NCI UM1 CA137443. Funding Information: Manmeet Ahluwalia: Receipt of grants/research supports: Astrazeneca, Abbvie, BMS, Bayer, Incyte, Pharmacyclics, Novocure, Merck. Receipt of honoraria or consultation fees: Elsevier, Wiley, Astrazeneca, Abvvie, VBI Vaccines, Flatiron, Varian Medical Systems, Prime Education, Bayer, karyopharm, Tocagen, Forma therapeutics. Stock shareholder: Doctible, Mimivax. Stephen J. Bagley: Research support from Eli Lilly, Incyte, Novocure, and Tesaro. Participated on advisory boards for Bayer, Northwest Biotherapeutics, and Novocure. Jian L. Campian: Consultant for Alexion, Abbvie, Arbor Pharmaceuticals, Dova Pharmaceuticals, Inovio Pharmaceuticals, Incyte, Novocure. Research support from Merck and NeoImmuneTech. Evanthia Galanis: General Consulting from MedImmune, Inc; F. Hoffman La Roche, Ltd (compensation to Mayo), Tactical Therapeutics, Inc; Oncorus (personal compensation). Advisory board on Vyriad (compensation to Mayo), Celgene Corporation; KIYATEC (personal compensation). Clinical Trial Funding from MedImmune, Inc.; Denovo Biopharma; Tracon; Genentech; Bristol-Myers Squibb (Mayo). Matthias Holdhoff: Consulting relationships/advisory boards with Celgene, Abbvie, BTG International Ltd, NewLink Genetics, DPClinical. Eudocia Q. Lee: Consulting for Eli Lilly. Royalties from Up to Date, Inc. Honoraria from Prime Oncology. Glenn Lesser: Research support (paid to institution) from Novartis, Vascular Biogenics, Pfizer, Incyte, New Link Genetics; Consulting for Monteris Medical, Cancer Expert Now; DSMB membership for Stemline Therapeutics, Agios Minesh Mehta: Consulting relationships with honoraria with Varian, Agenus, Insys, Remedy, IBA, Astra-Zeneca, Celgene, Tocagen, Abbvie; Board of Directors position with stock options with Oncoceutics; and DSMB for Monteris. L. Burt Nabors: Scientific advisory board for Karyopharm, Blue Earth Diagnostics, and BTG Pharmaceuticals David Reardon: Research support (paid to institution): Acerta Phamaceuticals; Agenus; Celldex; EMD Serono; Incyte; Inovio; Midatech; Omniox; Tragara. Advisory/consultation (paid to self): Abbvie; Advantagene; Agenus; Bristol-Myers Squibb; Celldex; EMD Serono; Genentech/Roche; Inovio; Merck; Merck KGaA; Monteris; Novocure; Oncorus; Oxigene; Regeneron; Stemline; Taiho Oncology, Inc. Honoraria (paid to self): Abbvie; Advantagene; Agenus; Bristol-Myers Squibb; Celldex; EMD Serono; Genentech/Roche; Inovio; Merck; Merck KGaA; Monteris; Novocure; Oncorus; Oxigene; Regeneron; Stemline; Taiho Oncology, Inc. Solmaz Sahebjam: Research support (paid to institution) from BMS and Merck. Roy E. Strowd: Research support (paid to institution) from JAZZ Pharmaceuticals, Conquer Cancer Foundation of the American Society of Clinical Oncology, Southeastern Brain Tumor Foundation, Vaximm Pharmaceuticals. Consulting for Novocure, Peloton Therapeutics, Monteris Medical. Editorial Stipend: American Academy of Neurology. Martin van den Bent: Consultanting for Cellgene, BMS, Agios, Boehringer, Abbvie, Bayer, Carthera. Michael Vogelbaum: Indirect equity and patient royalty interests from Infuseon Therapeutics. Honoraria from Celgene, Tocagen, and Blue Earth Diagnostics. Tobias Walbert: Advisory board of Orbus Therapeutics, Tocagen. Michael Weller: Research grants from Abbvie, Bayer, Merck, Sharp & Dohme (MSD), Dracen, Merck (EMD), Novocure, OGD2, Piqur, Roche and Adastra. Honoraria for lectures or advisory board participation or consulting from Abbvie, Basilea, Bristol Meyer Squibb, Celgene, Merck, Sharp & Dohme (MSD), Merck (EMD), Novocure, Orbus, Roche, Teva, Tocagen. Patrick Wen: Research Support from Agios, Astra Zeneca, Beigene, Celgene, Eli Lily, Genentech/Roche, Kazia, MediciNova, Merck, Novartis, Oncoceutics, Sanofi-Aventis, Vascular Biogenics, VBI Vaccines. Advisory Board for Agios, Astra Zeneca, Bayer, Blue Earth Diagnostics, Immunomic Therapeutics, Karyopharm, Kiyatec, Puma, Taiho, Vascular Biogenics, Deciphera, VBI Vaccines, Tocagen. Speaker for Merck, Prime Oncology. No conflicts reported for Susan M. Chang, Mark R. Gilbert, Stuart Grossman, Frank S. Lieberman, Marta Penas-Prado, Karisa Schreck, and Joohee Sul. No part of this manuscript has been previously published or submitted concurrently to any other journal. All coauthors have read and approved of its submission to this journal. Publisher Copyright: {\textcopyright} 2020 The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.",

year = "2020",

month = may,

day = "15",

doi = "10.1093/neuonc/noaa015",

language = "English",

volume = "22",

pages = "601--612",

journal = "Neuro-Oncology",

issn = "1522-8517",

number = "5",

}

Lee, EQ, Lee, EQ, Weller, M, Sul, J, Bagley, SJ, Sahebjam, S, Van Den Bent, M, Ahluwalia, M, Campian, JL, Galanis, E, Gilbert, MR, Holdhoff, M, Lesser, GJ, Lieberman, FS, Mehta, MP, Penas-Prado, M, Schreck, KC, Strowd, RE, Vogelbaum, MA, Walbert, T, Chang, SM, Nabors, LB, Grossman, S, Reardon, DA, Reardon, DA, Wen, PY & Wen, PY 2020, 'Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients', Neuro-oncology, vol. 22, no. 5, pp. 601-612. https://doi.org/10.1093/neuonc/noaa015

Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. / Lee, Eudocia Q.; Lee, Eudocia Q.; Weller, Michael; Sul, Joohee; Bagley, Stephen J.; Sahebjam, Solmaz; Van Den Bent, Martin; Ahluwalia, Manmeet; Campian, Jian L.; Galanis, Evanthia; Gilbert, Mark R.; Holdhoff, Matthias; Lesser, Glenn J.; Lieberman, Frank S.; Mehta, Minesh P.; Penas-Prado, Marta; Schreck, Karisa C.; Strowd, Roy E.; Vogelbaum, Michael A.; Walbert, Tobias; Chang, Susan M.; Nabors, L. Burt; Grossman, Stuart; Reardon, David A.; Reardon, David A.; Wen, Patrick Y.; Wen, Patrick Y.

In: Neuro-oncology, Vol. 22, No. 5, 15.05.2020, p. 601-612.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

AU - Lee, Eudocia Q.

AU - Weller, Michael

AU - Sul, Joohee

AU - Bagley, Stephen J.

AU - Sahebjam, Solmaz

AU - Van Den Bent, Martin

AU - Ahluwalia, Manmeet

AU - Campian, Jian L.

AU - Galanis, Evanthia

AU - Gilbert, Mark R.

AU - Holdhoff, Matthias

AU - Lesser, Glenn J.

AU - Lieberman, Frank S.

AU - Mehta, Minesh P.

AU - Penas-Prado, Marta

AU - Schreck, Karisa C.

AU - Strowd, Roy E.

AU - Vogelbaum, Michael A.

AU - Walbert, Tobias

AU - Chang, Susan M.

AU - Nabors, L. Burt

AU - Grossman, Stuart

AU - Reardon, David A.

AU - Wen, Patrick Y.

N1 - Funding Information: This work was supported by the Adult Brain Tumor Consortium (ABTC) NIH/NCI UM1 CA137443. Funding Information: Manmeet Ahluwalia: Receipt of grants/research supports: Astrazeneca, Abbvie, BMS, Bayer, Incyte, Pharmacyclics, Novocure, Merck. Receipt of honoraria or consultation fees: Elsevier, Wiley, Astrazeneca, Abvvie, VBI Vaccines, Flatiron, Varian Medical Systems, Prime Education, Bayer, karyopharm, Tocagen, Forma therapeutics. Stock shareholder: Doctible, Mimivax. Stephen J. Bagley: Research support from Eli Lilly, Incyte, Novocure, and Tesaro. Participated on advisory boards for Bayer, Northwest Biotherapeutics, and Novocure. Jian L. Campian: Consultant for Alexion, Abbvie, Arbor Pharmaceuticals, Dova Pharmaceuticals, Inovio Pharmaceuticals, Incyte, Novocure. Research support from Merck and NeoImmuneTech. Evanthia Galanis: General Consulting from MedImmune, Inc; F. Hoffman La Roche, Ltd (compensation to Mayo), Tactical Therapeutics, Inc; Oncorus (personal compensation). Advisory board on Vyriad (compensation to Mayo), Celgene Corporation; KIYATEC (personal compensation). Clinical Trial Funding from MedImmune, Inc.; Denovo Biopharma; Tracon; Genentech; Bristol-Myers Squibb (Mayo). Matthias Holdhoff: Consulting relationships/advisory boards with Celgene, Abbvie, BTG International Ltd, NewLink Genetics, DPClinical. Eudocia Q. Lee: Consulting for Eli Lilly. Royalties from Up to Date, Inc. Honoraria from Prime Oncology. Glenn Lesser: Research support (paid to institution) from Novartis, Vascular Biogenics, Pfizer, Incyte, New Link Genetics; Consulting for Monteris Medical, Cancer Expert Now; DSMB membership for Stemline Therapeutics, Agios Minesh Mehta: Consulting relationships with honoraria with Varian, Agenus, Insys, Remedy, IBA, Astra-Zeneca, Celgene, Tocagen, Abbvie; Board of Directors position with stock options with Oncoceutics; and DSMB for Monteris. L. Burt Nabors: Scientific advisory board for Karyopharm, Blue Earth Diagnostics, and BTG Pharmaceuticals David Reardon: Research support (paid to institution): Acerta Phamaceuticals; Agenus; Celldex; EMD Serono; Incyte; Inovio; Midatech; Omniox; Tragara. Advisory/consultation (paid to self): Abbvie; Advantagene; Agenus; Bristol-Myers Squibb; Celldex; EMD Serono; Genentech/Roche; Inovio; Merck; Merck KGaA; Monteris; Novocure; Oncorus; Oxigene; Regeneron; Stemline; Taiho Oncology, Inc. Honoraria (paid to self): Abbvie; Advantagene; Agenus; Bristol-Myers Squibb; Celldex; EMD Serono; Genentech/Roche; Inovio; Merck; Merck KGaA; Monteris; Novocure; Oncorus; Oxigene; Regeneron; Stemline; Taiho Oncology, Inc. Solmaz Sahebjam: Research support (paid to institution) from BMS and Merck. Roy E. Strowd: Research support (paid to institution) from JAZZ Pharmaceuticals, Conquer Cancer Foundation of the American Society of Clinical Oncology, Southeastern Brain Tumor Foundation, Vaximm Pharmaceuticals. Consulting for Novocure, Peloton Therapeutics, Monteris Medical. Editorial Stipend: American Academy of Neurology. Martin van den Bent: Consultanting for Cellgene, BMS, Agios, Boehringer, Abbvie, Bayer, Carthera. Michael Vogelbaum: Indirect equity and patient royalty interests from Infuseon Therapeutics. Honoraria from Celgene, Tocagen, and Blue Earth Diagnostics. Tobias Walbert: Advisory board of Orbus Therapeutics, Tocagen. Michael Weller: Research grants from Abbvie, Bayer, Merck, Sharp & Dohme (MSD), Dracen, Merck (EMD), Novocure, OGD2, Piqur, Roche and Adastra. Honoraria for lectures or advisory board participation or consulting from Abbvie, Basilea, Bristol Meyer Squibb, Celgene, Merck, Sharp & Dohme (MSD), Merck (EMD), Novocure, Orbus, Roche, Teva, Tocagen. Patrick Wen: Research Support from Agios, Astra Zeneca, Beigene, Celgene, Eli Lily, Genentech/Roche, Kazia, MediciNova, Merck, Novartis, Oncoceutics, Sanofi-Aventis, Vascular Biogenics, VBI Vaccines. Advisory Board for Agios, Astra Zeneca, Bayer, Blue Earth Diagnostics, Immunomic Therapeutics, Karyopharm, Kiyatec, Puma, Taiho, Vascular Biogenics, Deciphera, VBI Vaccines, Tocagen. Speaker for Merck, Prime Oncology. No conflicts reported for Susan M. Chang, Mark R. Gilbert, Stuart Grossman, Frank S. Lieberman, Marta Penas-Prado, Karisa Schreck, and Joohee Sul. No part of this manuscript has been previously published or submitted concurrently to any other journal. All coauthors have read and approved of its submission to this journal. Publisher Copyright: © 2020 The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

PY - 2020/5/15

Y1 - 2020/5/15

N2 - Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

AB - Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

KW - clinical trials

KW - eligibility

KW - exclusion criteria

KW - inclusion criteria

KW - primary brain tumor

UR - http://www.scopus.com/inward/record.url?scp=85084932031&partnerID=8YFLogxK

U2 - 10.1093/neuonc/noaa015

DO - 10.1093/neuonc/noaa015

M3 - Review article

C2 - 31974566

AN - SCOPUS:85084932031

VL - 22

SP - 601

EP - 612

JO - Neuro-Oncology

JF - Neuro-Oncology

SN - 1522-8517

IS - 5

ER -

Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

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