Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

Autor: Bonnie Addario, Jan Geissler, Marcia K. Horn, Linda U. Krebs, Deborah Maskens, Kathy Oliver, Ananda Plate, Erin Schwartz, Nicole Willmarth

Publikováno v: Health Expectations, Vol 23, Iss 1, Pp 41-51 (2020)

Abstract Context Patient‐reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies and other health‐care decision‐makers. In addition,

Externí odkaz: https://doaj.org/article/905a28ee91614c4eb6dd98134b36a837

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

Autor: Madeline Pe, Ahu Alanya, Ragnhild Sorum Falk, Cecilie Delphin Amdal, Kristin Bjordal, Jane Chang, Paul Cislo, Corneel Coens, Linda Dirven, Rebecca M Speck, Kristina Fitzgerald, Jayne Galinsky, Johannes M Giesinger, Bernhard Holzner, Saskia Le Cessie, Daniel O'Connor, Kathy Oliver, Vivek Pawar, Chantal Quinten, Michael Schlichting, Jinma Ren, Satrajit Roychoudhury, Martin J B Taphoorn, Galina Velikova, Lisa M Wintner, Ingolf Griebsch, Andrew Bottomley, Cat Bui, Nnadozie Emechebe, Rajesh Kamalakar, Elektra Papadopoulos, Kavita Sail, Rohini Sen, Sean C Turner, Kim Cocks, Jaap Reijneveld, Christoph Gerlinger, Karen Keating, Yun Su, Birgit Wolf, Miaomiao Ge, Anders Ingelgaard, Barbara Peil, Maarten Voorhaar, Brendon Wong, Gracia Dekanic Arbanas, Karin Kuljanic, Duska Petranovic, Ivana Rede, Juan Arraras, Stephen Joel Coons, Sonya Eremenco, Lindsey Murray, Bryce Reeve, Corinne De Vries, Ralf Herold, Francesco Pignatti, Abigirl Machingura, Francesca Martinelli, Jammbe Musoro, Martine Piccart, Jorge Barriuso, Nathan Cherny, Ourania Dafni, Elisabeth De Vries, Bishal Gyawali, Barbara Kiesewetter, Sjoukje Oosting, Felipe Roitberg, Gerhard Rumpold, Felix Schoepf, Michael Tschuggnall, Jennifer Black, Maxime Sasseville, Katherine Soltys, Montserrat Ferrer, Olatz Garin, Gemma Vilagut, Christoph Schürmann, Stefanie Thomas, Beate Wieseler, Claire Snyder, Ariel Alonso Abad, Kris Bogaerts, Febe Brackx, Geert Molenberghs, Geert Verbeke, Cristián Frigolett Catalan, Jan Choi, Doranne Thomassen, Jan Geissler, Willi Sauerbrei, Franziska Gross, Micha Johannes Pilz, Yolanda Barbachano, Lisa Campbell, Khadija Rantell, Gregoire Desplanques, Antoine Regnault, Kate Morgan, Ananda Plate, Silene ten Seldam, Mitsumi Terada, Junki Mizusawa, Sandra Mitchell, Ashley Wilder Smith, Tove Ragna Reksten, Anja Schiel, Kenth Louis Hansen Joseph, Alicyn Campbell, Joseph Cappelleri, Patrizia de Besi, Alexander Russell-Smith, Rickard Sandin, Carla Mamolo, Michael Brundage, Dongsheng Tu, Mogens Groenvold, Morten Petersen, Charlie Cleeland, Lori Williams, Xin Shelley Wang, Jolie Ringash, Melanie Calvert, Samantha Cruz Rivera, Olalekan Lee Aiyegbusi, Els Goetghebeur, Limin Liu, Kelly Van Lancker, Florien Boele, Alexandra Gilbert, Rosemary Peacock, Ethan Basch, Madeleine King, Claudia Rutherford, Vishal Bhatnagar, Mallorie Fiero, Erica Horodniceanu, Laura Lee Johnson, Paul Kluetz, Lisa Rodriguez

Publikováno v: SISAQOL-IMI Consortium & et al. 2023, ' Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures ', Lancet Oncology, vol. 24, no. 6, pp. e270-e283 . https://doi.org/10.1016/S1470-2045(23)00157-2

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit–risk assessment of cancer therapies. However, varying ways of analysing, presenting,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5c9c09b5d5b8e72fb9e0a912f8763409
https://research.manchester.ac.uk/en/publications/0a737d16-9496-4acc-8a64-8e7eca001879

[Changes resulting from the implementation of the new EU Clinical Trial Regulation 536/2014 from the perspective of patients]

Autor: Ingrid, Klingmann, Margit, Paul, Tamás, Bereczky, Ananda, Plate, Kerstin, Breithaupt-Grögler, Thomas M, Schindler, Jan, Geissler, T M, Schindler

Publikováno v: Bundesgesundheitsblatt, Gesundheitsforschung, GesundheitsschutzLiteratur.

The currently valid Regulation (EU) 536/2014 on clinical trials with medicinal products for human use brings some innovations that are of great importance for patients who participate in clinical trials and patients with a need for innovative therapi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::7fec00aef0b76ba6eac0d008cfe8d11a
https://pubmed.ncbi.nlm.nih.gov/36515718

Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

Autor: Deborah Maskens, Kathy Oliver, Bonnie J Addario, Nicole Willmarth, Linda U. Krebs, Ananda Plate, Jan Geissler, Marcia K. Horn, Erin S. Schwartz

Publikováno v: Health Expectations : An International Journal of Public Participation in Health Care and Health Policy
Health Expectations, Vol 23, Iss 1, Pp 41-51 (2020)

Context Patient‐reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies and other health‐care decision‐makers. In addition, PRO data

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::91d086ccce35858a4dfb8f0f6da92e94
http://europepmc.org/articles/PMC6978854

Incorporating patient preferences into drug development and regulatory decision making

Autor: Hans L. Hillege, Tomas Salmonson, Francesco Pignatti, Isabelle Moulon, Bettina Ryll, Douwe Postmus, Maria Mavris, Ananda Plate, Hans-Georg Eichler, Nathalie Bere

Publikováno v: Clinical Pharmacology & Therapeutics, 99(5), 548-554. Nature Publishing Group

Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and methodology for such studies have not been agreed upon. The European Medicines Agency (EMA) cond

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ffad918c56ff573f5d6e82682dfc668c
https://doi.org/10.1002/cpt.332