Original language | English (US) |
---|---|
Pages (from-to) | 643-650 |
Number of pages | 8 |
Journal | The Lancet Neurology |
Volume | 11 |
Issue number | 7 |
DOIs |
|
State | Published - Jul 2012 |
ASJC Scopus subject areas
- Clinical Neurology
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Sham neurosurgical procedures in clinical trials for neurodegenerative diseases : Scientific and ethical considerations. / Galpern, Wendy R.; Corrigan-Curay, Jacqueline; Lang, Anthony E. et al.
In: The Lancet Neurology, Vol. 11, No. 7, 07.2012, p. 643-650.Research output: Contribution to journal › Comment/debate › peer-review
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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.
PY - 2012/7
Y1 - 2012/7
UR - http://www.scopus.com/inward/record.url?scp=84862311445&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84862311445&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(12)70064-9
DO - 10.1016/S1474-4422(12)70064-9
M3 - Comment/debate
C2 - 22710757
AN - SCOPUS:84862311445
VL - 11
SP - 643
EP - 650
JO - The Lancet Neurology
JF - The Lancet Neurology
SN - 1474-4422
IS - 7
ER -