Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations

Wendy R. Galpern; Jacqueline Corrigan-Curay; Anthony E. Lang; Jeffrey Kahn; Danilo Tagle; Roger A. Barker; Thomas B. Freeman; Christopher G. Goetz; Karl Kieburtz; Scott Y.H. Kim; Steven Piantadosi; Amy Comstock Rick; Howard J. Federoff

doi:10.1016/S1474-4422(12)70064-9

Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations

Wendy R. Galpern, Jacqueline Corrigan-Curay, Anthony E. Lang, Jeffrey Kahn, Danilo Tagle, Roger A. Barker, Thomas B. Freeman, Christopher G. Goetz, Karl Kieburtz, Scott Y.H. Kim, Steven Piantadosi, Amy Comstock Rick, Howard J. Federoff

Research output: Contribution to journal › Comment/debate › peer-review

Original language	English (US)
Pages (from-to)	643-650
Number of pages	8
Journal	The Lancet Neurology
Volume	11
Issue number	7
DOIs	https://doi.org/10.1016/S1474-4422(12)70064-9
State	Published - Jul 2012

ASJC Scopus subject areas

Clinical Neurology

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10.1016/S1474-4422(12)70064-9

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Galpern, W. R., Corrigan-Curay, J., Lang, A. E., Kahn, J., Tagle, D., Barker, R. A., Freeman, T. B., Goetz, C. G., Kieburtz, K., Kim, S. Y. H., Piantadosi, S., Comstock Rick, A., & Federoff, H. J. (2012). Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations. The Lancet Neurology, 11(7), 643-650. https://doi.org/10.1016/S1474-4422(12)70064-9

Galpern, WR, Corrigan-Curay, J, Lang, AE, Kahn, J, Tagle, D, Barker, RA, Freeman, TB, Goetz, CG, Kieburtz, K, Kim, SYH, Piantadosi, S, Comstock Rick, A & Federoff, HJ 2012, 'Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations', The Lancet Neurology, vol. 11, no. 7, pp. 643-650. https://doi.org/10.1016/S1474-4422(12)70064-9

@article{d55c2d59eb33487f8338467bb67987d9,

title = "Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations",

author = "Galpern, {Wendy R.} and Jacqueline Corrigan-Curay and Lang, {Anthony E.} and Jeffrey Kahn and Danilo Tagle and Barker, {Roger A.} and Freeman, {Thomas B.} and Goetz, {Christopher G.} and Karl Kieburtz and Kim, {Scott Y.H.} and Steven Piantadosi and {Comstock Rick}, Amy and Federoff, {Howard J.}",

note = "Funding Information: The National Institutes of Health (NIH) convened a meeting of international experts to discuss the complex issues surrounding the decision to include sham neurosurgical procedures in clinical trials at a workshop entitled Sham Neurological Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations (June 30–July 1, 2010). The deliberations at this meeting were used in the development of this manuscript, and the authors acknowledge the contributions of the meeting participants. Authors were selected by the Organising Committee (WRG, JC-C, AEL, DT, and HJF) to represent the areas of expertise and opinions represented at the meeting. Authors include the members of the Organising Committee and a subset of meeting participants with expertise in clinical trials, neurology, neurosurgery, basic science research, ethics, and patient advocacy. A participant roster, slide presentations, written public comments, and a webcast are available online . The meeting was funded by the NIH . We also thank the following staff from the Office of Biotechnology Activities, NIH, for their contributions in bringing together this symposium: R Jambou, E Rosenthal, M O'Reilly, M Montgomery, and L Gargiulo. We also thank Perry Cohen for his contributions in the development of this symposium. The points described should not be interpreted to represent a consensus statement or the opinions of any individual or the NIH. Funding Information: AEL is an adviser for Abbott, Allon Therapeutics, AstraZeneca, Avanir Pharmaceuticals, Biovail, Boehringer-Ingelheim, Cephalon, Ceregene, Eisai, GlaxoSmithKline, Lundbeck, Medtronic, Merck Serono, Novartis, Santhera, Solvay, and Teva; has received grants from Canadian Institutes of Health Research, Dystonia Medical Research Foundation, Michael J Fox Foundation, National Parkinson Foundation, and Ontario Problem Gambling Research Centre; has received publishing royalties from Saunders, Wiley-Blackwell, Johns Hopkins Press, and Cambridge University Press; and has served as an expert witness in cases related to the welding industry. TBF is a consultant for SanBio, SpineGuard, Synthes Spine, Medtronic, Alnylam Pharmaceuticals, and Signus; Medical Director for Saneron CCEL Therapeutics; scientific advisory board member for NeuralStem; Founding Scientist, President, Chairman of the Board for Ciracell; receives fees for consulting for all the aforementioned companies; holds stock options for NeuralStem, Saneron, and Ciracell; has a licensing agreement with Medtronic Neuromodulation; and holds patents and provisional patents, numbers 7896889, 7981120, 7963980, 8012159 B2, 7699854, 7416885, and 6528245. CGG receives honoraria for consulting and advisory board membership from Addex Pharma, Asubio, Biovail Technologies, Boston Scientific, Cleveland Medical Devices, Decision Resources, Dixon Group, ICON Clinical Research, Impax Pharmaceuticals, Ingenix (i3 Research), Intec Pharmaceuticals, Kenes International, Motac Neurosciences, Oxford Biomedica, United Bioscience Corporation, and UCB; grants or research funding from the National Institutes of Health (NIH) and Michael J Fox Foundation; honoraria from the Movement Disorder Society, American Academy of Neurology, University of Pennsylvania, Washington University, and University of Michigan; and royalties from Oxford University Press, Elsevier Publishers, Wolters Kluwer Health, and Lippincott, Wilkins and Williams. CGG directs the Rush Parkinson's Disease Research Center, which receives support from the Parkinson's Disease Foundation, and directs the translation programme for the MDS-UPDRS (Movement Disorder Society unified Parkinson's disease rating scale) and UDysRS (unified dyskinesia rating scale), for which he receives funds from the Movement Disorder Society. KK is a consultant for the National Institute of Neurological Disorders and Stroke (NINDS), The US Food and Drug Administration, The US Veteran's Administration, Abbott, Acorda, Aptiv, Biogen Idec, Biotie, Biovail, Boehringer Ingelheim, Ceregene, Civitas, Clintrex, Cynapsus, EMD Merck Serono, Genzyme, Impax, Intec, Ipsen, Isis, Knopp, Lilly, Link Medicine, Lundbeck, LZ Therapeutics, Merz, Novartis, Orion, Otsuka, Pharm2B, Phytopharm, Schering-Plough, Siena Biotech, Synosia, Solvay, Synagile, Teva, UCB Pharma, Vaccinex, Vectura, and Xenoport; receives grants or research support from Medivation, Michael J Fox Foundation, National Eye Institute, NINDS, National Institute on Aging (NIA), National Institute of Child Health and Human Development, Neurosearch, and Pfizer; and does legal consulting for Pfizer, Thompson Hine, and welding rod litigation defendants. HJF is founder, equity participant, and scientific advisor for MedGenesis; founder and equity participant of Socratec; board member for the American Federation for Aging Research and Biomedical Research and Education Foundation; adviser for Oxford University Parkinson's Disease Center; and has received grants from NINDS, NIA, and the Department of Defense. All other authors declare that they have no conflicts of interest. Copyright: Copyright 2013 Elsevier B.V., All rights reserved.",

year = "2012",

month = jul,

doi = "10.1016/S1474-4422(12)70064-9",

language = "English (US)",

volume = "11",

pages = "643--650",

journal = "The Lancet Neurology",

issn = "1474-4422",

publisher = "Lancet Publishing Group",

number = "7",

}

TY - JOUR

T1 - Sham neurosurgical procedures in clinical trials for neurodegenerative diseases

T2 - Scientific and ethical considerations

AU - Galpern, Wendy R.

AU - Corrigan-Curay, Jacqueline

AU - Lang, Anthony E.

AU - Kahn, Jeffrey

AU - Tagle, Danilo

AU - Barker, Roger A.

AU - Freeman, Thomas B.

AU - Goetz, Christopher G.

AU - Kieburtz, Karl

AU - Kim, Scott Y.H.

AU - Piantadosi, Steven

AU - Comstock Rick, Amy

AU - Federoff, Howard J.

N1 - Funding Information: The National Institutes of Health (NIH) convened a meeting of international experts to discuss the complex issues surrounding the decision to include sham neurosurgical procedures in clinical trials at a workshop entitled Sham Neurological Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations (June 30–July 1, 2010). The deliberations at this meeting were used in the development of this manuscript, and the authors acknowledge the contributions of the meeting participants. Authors were selected by the Organising Committee (WRG, JC-C, AEL, DT, and HJF) to represent the areas of expertise and opinions represented at the meeting. Authors include the members of the Organising Committee and a subset of meeting participants with expertise in clinical trials, neurology, neurosurgery, basic science research, ethics, and patient advocacy. A participant roster, slide presentations, written public comments, and a webcast are available online . The meeting was funded by the NIH . We also thank the following staff from the Office of Biotechnology Activities, NIH, for their contributions in bringing together this symposium: R Jambou, E Rosenthal, M O'Reilly, M Montgomery, and L Gargiulo. We also thank Perry Cohen for his contributions in the development of this symposium. The points described should not be interpreted to represent a consensus statement or the opinions of any individual or the NIH. Funding Information: AEL is an adviser for Abbott, Allon Therapeutics, AstraZeneca, Avanir Pharmaceuticals, Biovail, Boehringer-Ingelheim, Cephalon, Ceregene, Eisai, GlaxoSmithKline, Lundbeck, Medtronic, Merck Serono, Novartis, Santhera, Solvay, and Teva; has received grants from Canadian Institutes of Health Research, Dystonia Medical Research Foundation, Michael J Fox Foundation, National Parkinson Foundation, and Ontario Problem Gambling Research Centre; has received publishing royalties from Saunders, Wiley-Blackwell, Johns Hopkins Press, and Cambridge University Press; and has served as an expert witness in cases related to the welding industry. TBF is a consultant for SanBio, SpineGuard, Synthes Spine, Medtronic, Alnylam Pharmaceuticals, and Signus; Medical Director for Saneron CCEL Therapeutics; scientific advisory board member for NeuralStem; Founding Scientist, President, Chairman of the Board for Ciracell; receives fees for consulting for all the aforementioned companies; holds stock options for NeuralStem, Saneron, and Ciracell; has a licensing agreement with Medtronic Neuromodulation; and holds patents and provisional patents, numbers 7896889, 7981120, 7963980, 8012159 B2, 7699854, 7416885, and 6528245. CGG receives honoraria for consulting and advisory board membership from Addex Pharma, Asubio, Biovail Technologies, Boston Scientific, Cleveland Medical Devices, Decision Resources, Dixon Group, ICON Clinical Research, Impax Pharmaceuticals, Ingenix (i3 Research), Intec Pharmaceuticals, Kenes International, Motac Neurosciences, Oxford Biomedica, United Bioscience Corporation, and UCB; grants or research funding from the National Institutes of Health (NIH) and Michael J Fox Foundation; honoraria from the Movement Disorder Society, American Academy of Neurology, University of Pennsylvania, Washington University, and University of Michigan; and royalties from Oxford University Press, Elsevier Publishers, Wolters Kluwer Health, and Lippincott, Wilkins and Williams. CGG directs the Rush Parkinson's Disease Research Center, which receives support from the Parkinson's Disease Foundation, and directs the translation programme for the MDS-UPDRS (Movement Disorder Society unified Parkinson's disease rating scale) and UDysRS (unified dyskinesia rating scale), for which he receives funds from the Movement Disorder Society. KK is a consultant for the National Institute of Neurological Disorders and Stroke (NINDS), The US Food and Drug Administration, The US Veteran's Administration, Abbott, Acorda, Aptiv, Biogen Idec, Biotie, Biovail, Boehringer Ingelheim, Ceregene, Civitas, Clintrex, Cynapsus, EMD Merck Serono, Genzyme, Impax, Intec, Ipsen, Isis, Knopp, Lilly, Link Medicine, Lundbeck, LZ Therapeutics, Merz, Novartis, Orion, Otsuka, Pharm2B, Phytopharm, Schering-Plough, Siena Biotech, Synosia, Solvay, Synagile, Teva, UCB Pharma, Vaccinex, Vectura, and Xenoport; receives grants or research support from Medivation, Michael J Fox Foundation, National Eye Institute, NINDS, National Institute on Aging (NIA), National Institute of Child Health and Human Development, Neurosearch, and Pfizer; and does legal consulting for Pfizer, Thompson Hine, and welding rod litigation defendants. HJF is founder, equity participant, and scientific advisor for MedGenesis; founder and equity participant of Socratec; board member for the American Federation for Aging Research and Biomedical Research and Education Foundation; adviser for Oxford University Parkinson's Disease Center; and has received grants from NINDS, NIA, and the Department of Defense. All other authors declare that they have no conflicts of interest. Copyright: Copyright 2013 Elsevier B.V., All rights reserved.

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Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: Scientific and ethical considerations

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