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An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators.
Published in:
Journal of Market Access & Health Policy, 2024, v. 12, n. 1, p. 21, doi. 10.3390/jmahp12010004
By:
- Desmet, Thomas;
- Julian, Elaine;
- Van Dyck, Walter;
- Huys, Isabelle;
- Simoens, Steven;
- Giuliani, Rosa;
- Toumi, Mondher;
- Dierks, Christian;
- Dierks, Juliana;
- Cardone, Antonella;
- Houÿez, Francois;
- Pavlovic, Mira;
- Berntgen, Michael;
- Mol, Peter;
- Schiel, Anja;
- Goettsch, Wim;
- Gianfrate, Fabrizio;
- Capri, Stefano;
- Ryan, James;
- Ducournau, Pierre
Publication type:
Article
The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy's multi-stakeholder preconvention questionnaire.
Published in:
Journal of Market Access & Health Policy, 2023, v. 11, n. 1, p. 1, doi. 10.1080/20016689.2023.2217543
By:
- Van Haesendonck, Lauren;
- Ruof, Jörg;
- Desmet, Thomas;
- Van Dyck, Walter;
- Simoens, Steven;
- Huys, Isabelle;
- Giuliani, Rosa;
- Toumi, Mondher;
- Dierks, Christian;
- Dierks, Juliana;
- Cardone, Antonella;
- Houÿez, Francois;
- Pavlovic, Mira;
- Berntgen, Michael;
- Mol, Peter G. M.;
- Schiel, Anja;
- Goettsch, Wim;
- Gianfrate, Fabrizio;
- Capri, Stefano;
- Ryan, James
Publication type:
Article
The use of external controls: To what extent can it currently be recommended?
Published in:
Pharmaceutical Statistics, 2021, v. 20, n. 6, p. 1002, doi. 10.1002/pst.2120
By:
- Burger, Hans Ulrich;
- Gerlinger, Christoph;
- Harbron, Chris;
- Koch, Armin;
- Posch, Martin;
- Rochon, Justine;
- Schiel, Anja
Publication type:
Article
Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.
Published in:
Health Research Policy & Systems, 2024, v. 22, n. 1, p. 1, doi. 10.1186/s12961-024-01154-2
By:
- Brinkhuis, Francine;
- Julian, Elaine;
- van den Ham, Hendrika;
- Gianfrate, Fabrizio;
- Strammiello, Valentina;
- Berntgen, Michael;
- Pavlovic, Mira;
- Mol, Peter;
- Wasem, Jürgen;
- Van Dyck, Walter;
- Cardone, Antonella;
- Dierks, Christian;
- Schiel, Anja;
- Bernardini, Renato;
- Solà-Morales, Oriol;
- Ruof, Jörg;
- Goettsch, Wim
Publication type:
Article
Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
Published in:
2022
By:
- Capkun, Gorana;
- Corry, Sorcha;
- Dowling, Oonagh;
- Zadeh Vosta Kolaei, Fatemeh Asad;
- Takyar, Shweta;
- Furtado, Cláudia;
- Jónsson, Páll;
- Kleinermans, Diane;
- Lambert, Laurie;
- Schiel, Anja;
- Facey, Karen;
- Asad Zadeh Vosta Kolaei, Fatemeh
Publication type:
journal article
Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
Published in:
International Journal of Technology Assessment in Health Care, 2021, v. 38, n. 1, p. 1, doi. 10.1017/S0266462322000605
By:
- Capkun, Gorana;
- Corry, Sorcha;
- Dowling, Oonagh;
- Asad Zadeh Vosta Kolaei, Fatemeh;
- Takyar, Shweta;
- Furtado, Cláudia;
- Jónsson, Páll;
- Kleinermans, Diane;
- Lambert, Laurie;
- Schiel, Anja;
- Facey, Karen
Publication type:
Article
A framework for assessing the impact of accelerated approval.
Published in:
PLoS ONE, 2022, v. 17, n. 6, p. 1, doi. 10.1371/journal.pone.0265712
By:
- Gould, A. Lawrence;
- Campbell, Robert K.;
- Loewy, John W.;
- Beckman, Robert A.;
- Dey, Jyotirmoy;
- Schiel, Anja;
- Burman, Carl-Fredrik;
- Zhou, Joey;
- Antonijevic, Zoran;
- Miller, Eva R.;
- Tang, Rui
Publication type:
Article
Commentary on "Target estimands for population-adjusted indirect comparisons".
Published in:
2022
By:
- Schiel, Anja
Publication type:
journal article
Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting.
Published in:
Frontiers in Pharmacology, 2021, v. 11, p. N.PAG, doi. 10.3389/fphar.2021.662642
By:
- Bakker, Elisabeth;
- Mol, Peter G. M.;
- Nabais, João;
- Vetter, Thorsten;
- Kretzler, Matthias;
- Nolan, John J.;
- Mayer, Gert;
- Sundgren, Anna K.;
- Heerspink, Hiddo J. L.;
- Schiel, Anja;
- de Vries, Sieta T.;
- Gomez, Maria F.;
- Schulze, Friedrich;
- de Zeeuw, Dick;
- Pena, Michelle J.
Publication type:
Article
Towards a better use of scientific advice for developers of advanced therapies.
Published in:
British Journal of Clinical Pharmacology, 2021, v. 87, n. 6, p. 2459, doi. 10.1111/bcp.14672
By:
- Tavridou, Anna;
- Rogers, Dolca;
- Bonelli, Milton;
- Schiel, Anja;
- Hidalgo‐Simon, Ana
Publication type:
Article
The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Published in:
British Journal of Clinical Pharmacology, 2018, v. 84, n. 5, p. 1013, doi. 10.1111/bcp.13524
By:
- Tafuri, Giovanni;
- Lucas, Inês;
- Estevão, Steve;
- Moseley, Jane;
- d'Andon, Anne;
- Bruehl, Hannah;
- Gajraj, Elangovan;
- Garcia, Sonia;
- Hedberg, Niklas;
- Massari, Marco;
- Molina, Andrea;
- Obach, Mercè;
- Osipenko, Leeza;
- Petavy, Frank;
- Petschulies, Marco;
- Pontes, Caridad;
- Russo, Pierluigi;
- Schiel, Anja;
- Van de Casteele, Marc;
- Zebedin‐Brandl, Eva‐Maria
Publication type:
Article
Generating the Right Evidence at the Right Time: Principles of a New Class of Flexible Augmented Clinical Trial Designs.
Published in:
Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 5, p. 1132, doi. 10.1002/cpt.2869
By:
- Dunger‐Baldauf, Cornelia;
- Hemmings, Rob;
- Bretz, Frank;
- Jones, Byron;
- Schiel, Anja;
- Holmes, Chris
Publication type:
Article
Estimands and Complex Innovative Designs.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 6, p. 1183, doi. 10.1002/cpt.2575
By:
- Collignon, Olivier;
- Schiel, Anja;
- Burman, Carl‐Fredrik;
- Rufibach, Kaspar;
- Posch, Martin;
- Bretz, Frank
Publication type:
Article
The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 5, p. 1093, doi. 10.1002/cpt.2534
By:
- Lasch, Florian;
- Psarelli, Eftychia‐Eirini;
- Herold, Ralf;
- Mattsson, Andrea;
- Guizzaro, Lorenzo;
- Pétavy, Frank;
- Schiel, Anja
Publication type:
Article
Collaborative Platform Trials to Fight COVID‐19: Methodological and Regulatory Considerations for a Better Societal Outcome.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 2, p. 311, doi. 10.1002/cpt.2183
By:
- Collignon, Olivier;
- Burman, Carl‐Fredrik;
- Posch, Martin;
- Schiel, Anja
Publication type:
Article
Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 3, p. 653, doi. 10.1002/cpt.1965
By:
- Tenhunen, Olli;
- Lasch, Florian;
- Schiel, Anja;
- Turpeinen, Miia
Publication type:
Article
Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 5, p. 1059, doi. 10.1002/cpt.1804
By:
- Collignon, Olivier;
- Gartner, Christian;
- Haidich, Anna‐Bettina;
- James Hemmings, Robert;
- Hofner, Benjamin;
- Pétavy, Frank;
- Posch, Martin;
- Rantell, Khadija;
- Roes, Kit;
- Schiel, Anja
Publication type:
Article
Recognizing that Evidence is Made, not Born.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 844, doi. 10.1002/cpt.1317
By:
- Lim, Robyn;
- Lee, David K.;
- Sabourin, Pierre;
- Ferguson, John;
- Metcalf, Marilyn;
- Smith, Meredith;
- Corriol‐Rohou, Solange;
- Eichler, Hans‐Georg;
- Lumpkin, Murray;
- Hirsch, Gigi;
- Chen, Inhua Muijrers;
- O'Rourke, Brian;
- Schiel, Anja;
- Crabb, Nick;
- Aronson, Naomi;
- Pezalla, Edmund;
- Boutin, Marc;
- Binder, Louise;
- Wilhelm, Linda
Publication type:
Article
Regulatory and Health Technology Assessment Considerations for Disease-Modifying Drugs in Alzheimer's Disease.
Published in:
2018
By:
- Bouvy, Jacoline C.;
- Jonsson, Pall;
- O'Rourke, Diana;
- Chadha, Antonella Santuccione;
- Hedberg, Niklas;
- Makady, Amr;
- Xoxi, Entela;
- Wied, Christine Gispen-de;
- Schiel, Anja;
- Long, Raj;
- Gallacher, John
Publication type:
journal article

Found: 19