At the 2011 NF Conference, the Children’s Tumor Foundation established the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration. REiNS was created to achieve consensus within the neurofibromatosis community about the design of future clinical trials, with a specific emphasis on endpoints. The Collaboration includes seven working groups that focus on imaging of tumor response; functional, visual, patient-reported, and neurocognitive outcomes; whole-body MRI; and disease biomarkers.
Thanks to the tremendous efforts of the REiNS co-chairs, Dr. Scott Plotkin and Dr. Brigitte Widemann, the Foundation is extremely excited to announce that a full Neurology supplement dedicated to the first series of recommendations by the REiNS Collaboration is now available. Thanks to Foundation sponsorship, the entire issue is open and available to ALL. (Please see below)
The Foundation is providing the articles free of charge in the hope that these recommendations will be used to standardize the measurement of clinical trial outcomes, and thus improve treatments for patients with NF.
Ultimately, this will allow the Foundation to engage industry partners and national regulatory agencies in the process of facilitating approval of drugs for patients with NF.
Neurology
November 2013; Vol. 81, No. 21 supplement 1
Achieving consensus for clinical trials: The REiNS International Collaboration
Scott R. Plotkin, Jaishri O. Blakeley, Eva Dombi, Michael J. Fisher, C. Oliver Hanemann, Karin S. Walsh, Pamela L. Wolters, and Brigitte C. Widemann
Neurology November 19, 2013 81:S1-S5
http://www.neurology.org/content/81/21_supplement_1/S1.abstract
Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials
Pamela L. Wolters, Staci Martin, Vanessa L. Merker, Kathy L. Gardner, Cynthia M. Hingtgen, James H. Tonsgard, Elizabeth K. Schorry, Andrea Baldwin, and For the REiNS International Collaboration
Neurology November 19, 2013 81:S6-S14
http://www.neurology.org/content/81/21_supplement_1/S6.abstract
Functional outcome measures for NF1-associated optic pathway glioma clinical trials
Michael J. Fisher, Robert A. Avery, Jeffrey C. Allen, Simone L. Ardern-Holmes, Larissa T. Bilaniuk, Rosalie E. Ferner, David H. Gutmann, Robert Listernick, Staci Martin, Nicole J. Ullrich, Grant T. Liu, and For the REiNS International Collaboration
Neurology November 19, 2013 81:S15-S24
http://www.neurology.org/content/81/21_supplement_1/S15.abstract
Hearing and facial function outcomes for neurofibromatosis 2 clinical trials
Scott R. Plotkin, Simone L. Ardern-Holmes, Fred G. Barker II, Jaishri O. Blakeley, D. Gareth Evans, Rosalie E. Ferner, Tessa A. Hadlock, Chris Halpin, and For the REiNS International Collaboration
Neurology November 19, 2013 81:S25-S32
http://www.neurology.org/content/81/21_supplement_1/S25.abstract
Recommendations for imaging tumor response in neurofibromatosis clinical trials
Eva Dombi, Simone L. Ardern-Holmes, Dusica Babovic-Vuksanovic, Fred G. Barker, Steve Connor, D. Gareth Evans, Michael J. Fisher, Stephane Goutagny, Gordon J. Harris, Diego Jaramillo, Matthias A. Karajannis, Bruce R. Korf, Victor Mautner, Scott R. Plotkin, Tina Y. Poussaint, Kent Robertson, Chie-Schin Shih, Brigitte C. Widemann, and For the REiNS International Collaboration
Neurology November 19, 2013 81:S33-S40
http://www.neurology.org/content/81/21_supplement_1/S33.abstract
Conclusions and future directions for the REiNS International Collaboration
Brigitte C. Widemann, Jaishri O. Blakeley, Eva Dombi, Michael J. Fisher, Clemens O. Hanemann, Karin S. Walsh, Pamela L. Wolters, and Scott R. Plotkin
Neurology November 19, 2013 81:S41-S44
http://www.neurology.org/content/81/21_supplement_1/S41.abstract
