Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Anja Schiel"'
Autor:
Francine Brinkhuis, Elaine Julian, Hendrika van den Ham, Fabrizio Gianfrate, Valentina Strammiello, Michael Berntgen, Mira Pavlovic, Peter Mol, Jürgen Wasem, Walter Van Dyck, Antonella Cardone, Christian Dierks, Anja Schiel, Renato Bernardini, Oriol Solà-Morales, Jörg Ruof, Wim Goettsch
Publikováno v:
Health Research Policy and Systems, Vol 22, Iss 1, Pp 1-12 (2024)
Abstract Background The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025
Externí odkaz:
https://doaj.org/article/660c1c179a5f4b32bace34cbb01905ab
Autor:
Thomas Desmet, Elaine Julian, Walter Van Dyck, Isabelle Huys, Steven Simoens, Rosa Giuliani, Mondher Toumi, Christian Dierks, Juliana Dierks, Antonella Cardone, Francois Houÿez, Mira Pavlovic, Michael Berntgen, Peter Mol, Anja Schiel, Wim Goettsch, Fabrizio Gianfrate, Stefano Capri, James Ryan, Pierre Ducournau, Oriol Solà-Morales, Jörg Ruof
Publikováno v:
Journal of Market Access & Health Policy, Vol 12, Iss 1, Pp 21-34 (2024)
Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore, we
Externí odkaz:
https://doaj.org/article/7f514bab01674db19ecb4093613aaea7
Autor:
Lauren Van Haesendonck, Jörg Ruof, Thomas Desmet, Walter Van Dyck, Steven Simoens, Isabelle Huys, Rosa Giuliani, Mondher Toumi, Christian Dierks, Juliana Dierks, Antonella Cardone, Francois Houÿez, Mira Pavlovic, Michael Berntgen, Peter G.M. Mol, Anja Schiel, Wim Goettsch, Fabrizio Gianfrate, Stefano Capri, James Ryan, Pierre Ducournau, Oriol Solà-Morales, Elaine Julian
Publikováno v:
Journal of Market Access & Health Policy, Vol 11, Iss 1 (2023)
ABSTRACTInvolvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process.A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA fr
Externí odkaz:
https://doaj.org/article/b464df9353d045aaaaa896a7a0f4680a
Autor:
A Lawrence Gould, Robert K Campbell, John W Loewy, Robert A Beckman, Jyotirmoy Dey, Anja Schiel, Carl-Fredrik Burman, Joey Zhou, Zoran Antonijevic, Eva R Miller, Rui Tang
Publikováno v:
PLoS ONE, Vol 17, Iss 6, p e0265712 (2022)
The FDA's Accelerated Approval program (AA) is a regulatory program to expedite availability of products to treat serious or life-threatening illnesses that lack effective treatment alternatives. Ideally, all of the many stakeholders such as patients
Externí odkaz:
https://doaj.org/article/df7c2634c3974c088d761e2046bb8771
Autor:
Elisabeth Bakker, Peter G. M. Mol, João Nabais, Thorsten Vetter, Matthias Kretzler, John J. Nolan, Gert Mayer, Anna K. Sundgren, Hiddo J. L. Heerspink, Anja Schiel, Sieta T. de Vries, Maria F. Gomez, Friedrich Schulze, Dick de Zeeuw, Michelle J. Pena, for the BEAt-DKD Consortium
Publikováno v:
Frontiers in Pharmacology, Vol 12 (2021)
Aim: This study aimed to identify from different stakeholders the benefits and obstacles of implementing precision medicine in diabetic kidney disease (DKD) and to build consensus about a way forward in order to treat, prevent, or even reverse this d
Externí odkaz:
https://doaj.org/article/f77b8bd284ea47e89bad5a6ed9657caf
Autor:
Limin Liu, Jungyeon Choi, Jammbe Z Musoro, Willi Sauerbrei, Cecilie Delphin Amdal, Ahu Alanya, Yolanda Barbachano, Joseph C Cappelleri, Ragnhild Sørum Falk, Mallorie H Fiero, Antoine Regnault, Jaap C Reijneveld, Rickard Sandin, Doranne Thomassen, Satrajit Roychoudhury, Els Goetghebeur, Saskia le Cessie, Olalekan Lee Aiyegbusi, Ethan Basch, Melanie Calvert, Alicyn Campbell, Joseph Cappelleri, Samantha Cruz Rivera, Mallorie Fiero, Rajesh Kamalakar, Karen Keating, Paul Kluetz, Geert Molenberghs, Jammbe Musoro, David Ness, Khadija Rantell, Jaap Reijneveld, Gerhard Rumpold, Alexander Russell-Smith, Claudia Rutherford, Kavita Sail, Maxime Sasseville, Anja Schiel, Michael Schlichting, Kathy Soltys, Ragnhild Sorum Falk, Yun Su, Silene ten Seldam, Kelly Van Lancker
Publikováno v:
Liu, L, Choi, J, Musoro, J Z, Sauerbrei, W, Amdal, C D, Alanya, A, Barbachano, Y, Cappelleri, J C, Falk, R S R, Fiero, M H, Regnault, A, Reijneveld, J C, SISAQOL-IMI Work Package 3, Sandin, R, Thomassen, D, Roychoudhury, S, Goetghebeur, E & le Cessie, S 2023, ' Single-arm studies involving patient-reported outcome data in oncology : a literature review on current practice ', The Lancet Oncology, vol. 24, no. 5, pp. e197-e206 . https://doi.org/10.1016/S1470-2045(23)00110-9
Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, an
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
https://research.manchester.ac.uk/en/publications/0a737d16-9496-4acc-8a64-8e7eca001879
Autor:
Gorana Capkun, Sorcha Corry, Oonagh Dowling, Fatemeh Asad Zadeh Vosta Kolaei, Shweta Takyar, Cláudia Furtado, Páll Jónsson, Diane Kleinermans, Laurie Lambert, Anja Schiel, Karen Facey
Publikováno v:
Capkun, G, Corry, S, Dowling, O, Asad Zadeh Vosta Kolaei, F, Takyar, S, Furtado, C, Jónsson, P, Kleinermans, D, Lambert, L, Schiel, A & Facey, K 2022, ' Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making? ', International journal of technology assessment in health care, vol. 38, no. 1, pp. e79 . https://doi.org/10.1017/S0266462322000605
Advances in the digitization of health systems and expedited regulatory approvals of innovative treatments have led to increased potential for the use of real-world data (RWD) to generate real-world evidence (RWE) to complement evidence from clinical
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d2c7f6c95c1e6445e86fa4761c837e98
https://hdl.handle.net/20.500.11820/723473b5-6889-4b77-a9e9-aaccf0109bd9
https://hdl.handle.net/20.500.11820/723473b5-6889-4b77-a9e9-aaccf0109bd9
Autor:
Anja Schiel
Publikováno v:
Statistics in medicineREFERENCES. 41(28)
Publikováno v:
Clinical Pharmacology & Therapeutics
Clinical Pharmacology and Therapeutics
Clinical Pharmacology and Therapeutics
For the development of coronavirus disease 2019 (COVID-19) drugs during the ongoing pandemic, speed is of essence whereas quality of evidence is of paramount importance. Although thousands of COVID-19 trials were rapidly started, many are unlikely to