Francesco Pignatti

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All published works

Action	Title	Year	Authors
+	Externally Controlled Studies Using Real-World Data in Patients With Hematological Cancers	2024	Sjoerd J. F. Hermans N Maas Yvette van Norden Avinash G. Dinmohamed Elizabeth Berkx Peter C. Huijgens Donna R. Rivera R. Angelo de Claro Francesco Pignatti Jurjen Versluis
+ PDF Chat	Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations	2024	Gerd Rippin Héctor Sanz Wilhelmina E. Hoogendoorn Nicolás Ballarini Joan Largent Eleni Demas Douwe Postmus Theodor Framke Lukas M. Aguirre Dávila Chantal Quinten
+ PDF Chat	Bayesian interim analysis for prospective randomized studies: reanalysis of the acute myeloid leukemia HOVON 132 clinical trial	2024	N Maas Jurjen Versluis Kazem Nasserinejad Joost van Rosmalen Thomas Pabst Johan Maertens Dimitri Breems Markus G. Manz Jacqueline Cloos Gert J. Ossenkoppele
+	Attitudes of healthcare professionals and drug regulators about progression-free survival as endpoint in the advanced cancer setting	2023	Douwe Postmus Saskia Litière Jan Bogaerts Jurjen Versluis Jan J. Cornelissen Francesco Pignatti
+	PCR20 Preferences for Cancer Treatments: A Discrete-Choice Experiment with Adult Patients with Cancer in Europe	2023	Willings Botha Stephanie Philpott Douwe Postmus Francesco Pignatti A.M. Rodriguez-Leboeuf
+	Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	2023	C. Mircea S. Tesileanu Francesco Pignatti Enrico Tognana A. J. B. Humphreys
+ PDF Chat	Quantitative Benefit-Risk Assessment in Medical Product Decision Making: A Good Practices Report of an ISPOR Task Force	2023	Tommi Tervonen Jorien Veldwijk Katherine Payne Xinyi Ng Bennett Levitan Leila G. Lackey Kevin Marsh Praveen Thokala Francesco Pignatti Anne Donnelly
+	The HOVON 100 Study in Adult Acute Lymphoblastic Leukemia Re-Analysed By Multi-State Modeling: Benefits and Risks of Clofarabine	2022	Sjoerd J. F. Hermans Yvette van Norden Jurjen Versluis Anita W. Rijneveld Okke de Weerdt Bart J. Biemond Arjan A. van de Loosdrecht Lotte E. van der Wagen Mar Bellido Michel van Gelder
+	Bayesian Inference for Optimization of Interim Analysis in Clinical Trials By Incorporation of Historical Data: Reanalysis of the HOVON AML 132 Clinical Trial	2022	Niek Van Der Maas Kazem Nasserinejad Thomas Pabst Johan Maertens Dimitri Breems Markus G. Manz Jacqueline Cloos Gert J. Ossenkoppele Yngvar Fløisand Patrycja Gradowska
+ PDF Chat	A simulated maximum likelihood procedure for analyzing imprecise trade‐off thresholds between the benefits and harms of medicines	2022	Douwe Postmus Francesco Pignatti Hans L. Hillege Tommi Tervonen
+	Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators	2022	Rajeshwari Sridhara Olga Marchenko Qing Jiang Elizabeth Barksdale Jie Chen Nancy A Dreyer Lola A. Fashoyin-Aje Elizabeth Garrett‐Mayer Nicole Gormley Thomas Gwise
+	A Review of Causal Inference for External Comparator Arm Studies	2022	Gerd Rippin Nicolás Ballarini Héctor Sanz Joan Largent Chantal Quinten Francesco Pignatti
+ PDF Chat	The value of anticancer drugs — a regulatory view	2021	Francesco Pignatti Ulla Wilking Douwe Postmus Nils Wilking Julio Delgado Jonas Bergh
+	Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth	2020	Hans‐Georg Eichler Francesco Pignatti Brigitte Schwarzer‐Daum Ana Hidalgo‐Simon Irmgard Eichler Peter Arlett A. J. B. Humphreys Spiros Vamvakas Nikolai C. Brun Guido Rasi
+ PDF Chat	Individual Trade-Offs Between Possible Benefits and Risks of Cancer Treatments: Results from a Stated Preference Study with Patients with Multiple Myeloma	2017	Douwe Postmus Sarah Richard Nathalie Bere Gert van Valkenhoef Jayne Galinsky Eric Low Isabelle Moulon Maria Mavris Tomas Salmonsson Beatriz Flores
+ PDF Chat	Eliciting Individual Patient Preferences on The Benefits and Risks of Cancer Treatments: Results From A Survey Conducted in Myeloma Patients	2016	Douwe Postmus Sarah Richard Nathalie Bere JL Hillege Eric Low Francesco Pignatti
+ PDF Chat	“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?	2016	H‐G Eichler Brigitte Bloechl‐Daum Philipp K. Bauer Frank Bretz Jeffrey S. Brown L Hampson Peter K. Honig Michael Krams Hubert G.M. Leufkens Robyn Lim
+	Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators	2015	Douwe Postmus Maria Mavris HL Hillege Tomas Salmonson Bettina Ryll Ananda Plate Isabelle Moulon H‐G Eichler Nathalie Bere Francesco Pignatti
+	Assessment of benefits and risks in development of targeted therapies for cancer — The view of regulatory authorities	2014	Francesco Pignatti Bertil Jönsson Gideon M. Blumenthal Robert Justice
+	The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation	2011	Francesco Pignatti Iordanis Gravanis Ralf Herold Spiros Vamvakas Bertil Jönsson M.L. Marty
+	Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?	2011	Francesco Pignatti Rob Hemmings Bertil Jönsson
+	The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome	2002	Francesco Pignatti B. Aronsson Nick Gate Spiros Vamvakas George N. Wade Isabelle Moulon Patrick Le Courtois
+	Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology	2002	Francesco Pignatti B. Aronsson Spiros Vamvakas George N. Wade Irene Papadouli Marisa Papaluca Isabelle Moulon Patrick Le Courtois
+	Design of equivalence studies: Facts and fantasies	1998	Richard Sylvester Laurence Collette Francesco Pignatti Patrick Therasse

Common Coauthors

Coauthor	Papers Together
Douwe Postmus	11
Jan J. Cornelissen	5
Jurjen Versluis	4
Spiros Vamvakas	4
Isabelle Moulon	4
Nathalie Bere	3
Bertil Jönsson	3
H‐G Eichler	2
N Maas	2
Tommi Tervonen	2
Markus G. Manz	2
Héctor Sanz	2
Patrycja Gradowska	2
Gerd Rippin	2
Gert J. Ossenkoppele	2
Sjoerd J. F. Hermans	2
George N. Wade	2
Chantal Quinten	2
Patrick Le Courtois	2
Johan Maertens	2
Maria Mavris	2
Eric Low	2
A. J. B. Humphreys	2
Dimitri Breems	2
Kazem Nasserinejad	2
Hans L. Hillege	2
Yngvar Fløisand	2
Nicolás Ballarini	2
Jacqueline Cloos	2
B Aronsson	2
Joan Largent	2
Sarah Richard	2
Yvette van Norden	2
Bob Löwenberg	2
Jayne Galinsky	1
Niek Van Der Maas	1
Martin Posch	1
Michel van Gelder	1
Qing Jiang	1
Irene Papadouli	1
Craig Tendler	1
R. Angelo de Claro	1
Harpreet Singh	1
Theodor Framke	1
Nils Wilking	1
Wilhelmina E. Hoogendoorn	1
Sebastian Schneeweiß	1
Peter Arlett	1
Peter K. Honig	1
Gerwin Huls	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+	Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators	2015	Douwe Postmus Maria Mavris HL Hillege Tomas Salmonson Bettina Ryll Ananda Plate Isabelle Moulon H‐G Eichler Nathalie Bere Francesco Pignatti	4
+ PDF Chat	A stochastic multicriteria model for evidence‐based decision making in drug benefit‐risk analysis	2011	Tommi Tervonen Gert van Valkenhoef Erik Buskens Hans L. Hillege Douwe Postmus	4
+ PDF Chat	The value of anticancer drugs — a regulatory view	2021	Francesco Pignatti Ulla Wilking Douwe Postmus Nils Wilking Julio Delgado Jonas Bergh	3
+	An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies	2011	Peter C. Austin	3
+ PDF Chat	Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review	2019	Sarah Goring Aliki Taylor Kerstin Müller Tina Jun Jian Li Ellen Korol Adrian R. Levy Nick Freemantle	3
+	Beyond Randomized Clinical Trials: Use of External Controls	2019	Heinz Schmidli Dieter A. Häring Marius Thomas Adrian Cassidy Sebastian Weber Frank Bretz	3
+ PDF Chat	Using Electronic Health Records to Derive Control Arms for Early Phase Single‐Arm Lung Cancer Trials: Proof‐of‐Concept in Randomized Controlled Trials	2019	Gillis Carrigan Samuel Whipple William B. Capra Michael D. Taylor Jeffrey S. Brown Michael W. Lu Brandon Arnieri Ryan Copping Kenneth J. Rothman	3
+	The Magic of Randomization versus the Myth of Real-World Evidence	2020	Rory Collins Louise Bowman Martin Landray Richard Peto	2
+ PDF Chat	The Use of External Controls in FDA Regulatory Decision Making	2021	Mahta Jahanshahi Keith Gregg Gillian Davis Adora Ndu Veronica Miller Jerry Vockley Cécile Ollivier Tanja Franolic Sharon Sakai	2
+	When Context Is Hard to Come By: External Comparators and How to Use Them	2020	Christina Mack Jennifer Christian Emma Brinkley Edward J. Warren Marni Hall Nancy A Dreyer	2
+ PDF Chat	Implementing Historical Controls in Oncology Trials	2021	Olivier Collignon Anna Schritz Riccardo Spezia Stephen Senn	2
+ PDF Chat	External control arms in oncology: current use and future directions	2022	Pallavi S. Mishra‐Kalyani L. Amiri Kordestani Donna R. Rivera Harpreet Singh Amna Ibrahim R. Angelo DeClaro Yuan Li Shen Shenghui Tang R. Sridhara Paul G. Kluetz	2
+	Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group	2011	A Stone William D. Bushnell Jon Denne Daniel J. Sargent Ohad Amit C. CHEN R. Bailey-Iacona Jeffrey D. Helterbrand Grant Williams	2
+ PDF Chat	A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG)	2020	Mercedeh Ghadessi Rui Tang Joey Tianyi Zhou Rong Liu Chenkun Wang Kiichiro Toyoizumi Chaoqun Mei Lixia Zhang C. Q. Deng Robert A. Beckman	2
+ PDF Chat	<p>Synthetic and External Controls in Clinical Trials – A Primer for Researchers</p>	2020	Kristian Thorlund Louis Dron Jay Park Edward J. Mills	2
+ PDF Chat	An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non–Small-Cell Lung Cancer	2019	Mark Stewart Andrew D. Norden Nancy A Dreyer Henry J. Henk Amy P. Abernethy Elizabeth A. Chrischilles Lawrence H. Kushi Aaron S. Mansfield Sean Khozin Elad Sharon	2
+ PDF Chat	A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data	2020	Christen Gray Fiona Grimson Deborah Layton Stuart J. Pocock Joseph Kim	2
+	Closed‐form variance estimator for weighted propensity score estimators with survival outcome	2018	David Hajage Guillaume Chauvet Lisa Belin Alexandre Lafourcade Florence Tubach Yann De Rycke	2
+ PDF Chat	The proportion of missing data should not be used to guide decisions on multiple imputation	2019	Paul Madley‐Dowd Rachael A. Hughes Kate Tilling Jon Heron	2
+ PDF Chat	Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation	2019	Hans‐Georg Eichler Franz Koenig Peter Arlett Harald Enzmann A. J. B. Humphreys Frank Pétavy Brigitte Schwarzer‐Daum Bruno Sepodes Spiros Vamvakas Guido Rasi	2
+	When Context Is Hard to Come By: External Comparators and How to Use Them	2019	Christina Mack Jennifer Christian Emma Brinkley Edward J. Warren Marni Hall Nancy A Dreyer	2
+ PDF Chat	Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms	2020	Mehmet Burcu Nancy A Dreyer Jessica M. Franklin Michael D. Blum Cathy W. Critchlow Eleanor M. Perfetto Wei Zhou	2
+ PDF Chat	Including historical data in the analysis of clinical trials: Is it worth the effort?	2017	Joost van Rosmalen David Dejardin Yvette van Norden Bob Löwenberg Emmanuel Lesaffre	2
+ PDF Chat	The use of external controls: To what extent can it currently be recommended?	2021	Hans Ulrich Burger Christoph Gerlinger Chris Harbron Armin Koch Martin Posch Justine Rochon Anja Schiel	2
+	Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making	2019	Jessica M. Franklin Robert J. Glynn David Martin Sebastian Schneeweiß	2
+	Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer	2022	Xiang Yin Pallavi S. Mishra-Kalyan Rajeshwari Sridhara Mark Stewart Elizabeth A. Stuart Ruthanna Davi	2
+ PDF Chat	Matching Methods for Causal Inference: A Review and a Look Forward	2010	Elizabeth A. Stuart	2
+	Application of the BRAT Framework to Case Studies: Observations and Insights	2010	B Levitan Elizabeth Andrews Alicia Gilsenan John G. Ferguson R A Noel Paul Coplan Filip Mussen	2
+ PDF Chat	Quantitative Benefit–Risk Assessment: State of the Practice Within Industry	2020	Meredith Y. Smith Janine A. van Til Rachael L. DiSantostefano Brett Hauber Kevin Marsh	2
+	Single-arm Trials with Historical Controls	2020	Samy Suissa	2
+	The role of nonrandomized trials in the evaluation of oncology drugs	2015	Richard Simon GM Blumenthal Rothenberg Ml Josh Sommer SA Roberts D. K. Armstrong LM LaVange Richard Pazdur	2
+	The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation	2011	Francesco Pignatti Iordanis Gravanis Ralf Herold Spiros Vamvakas Bertil Jönsson M.L. Marty	2
+ PDF Chat	The central role of the propensity score in observational studies for causal effects	1983	Paul R. Rosenbaum Donald B. Rubin	2
+	Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis	2011	Ohad Amit Frank Mannino A Stone William D. Bushnell Jonathan Denne Jeffrey D. Helterbrand Hans-Ulrich Burger	2
+ PDF Chat	“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?	2016	H‐G Eichler Brigitte Bloechl‐Daum Philipp K. Bauer Frank Bretz Jeffrey S. Brown L Hampson Peter K. Honig Michael Krams Hubert G.M. Leufkens Robyn Lim	2
+	The combination of randomized and historical controls in clinical trials	1976	Stuart J. Pocock	2
+ PDF Chat	Real-world Data for Clinical Evidence Generation in Oncology	2017	Sean Khozin Gideon M. Blumenthal Richard Pazdur	2
+ PDF Chat	The use of real-world data in cancer drug development	2018	Eva Skovlund Hubert G. M. Leufkens John F. Smyth	2
+ PDF Chat	Sample size considerations for historical control studies with survival outcomes	2015	Hong Zhu Song Zhang Chul Ahn	2
+ PDF Chat	Effect Estimates in Randomized Trials and Observational Studies: Comparing Apples With Apples	2019	Sara Lodi Andrew Phillips Jens Lundgren Roger Logan Shweta Sharma Stephen R. Cole Abdel Babiker Matthew Law Haitao Chu Dana Byrne	2
+ PDF Chat	Methods for external control groups for single arm trials or <scp>long‐term</scp> uncontrolled extensions to randomized clinical trials	2020	John D. Seeger Kourtney J. Davis Michelle R. Iannacone Wei Zhou Nancy A Dreyer Almut G. Winterstein Nancy C. Santanello Barry J. Gertz Jesse A. Berlin	2
+	Nonrandomized Real‐World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project	2019	Jessica M. Franklin Ajinkya Pawar David Martin Robert J. Glynn Mark Levenson Robert Temple Sebastian Schneeweiß	2
+ PDF Chat	Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?	2008	Lori E. Dodd Edward L. Korn Boris Freidlin C. Carl Jaffe Larry Rubinstein Janet Dancey Margaret Mooney	2
+ PDF Chat	A comparison of two methods of estimating propensity scores after multiple imputation	2012	Robin Mitra Jerome P. Reiter	1
+ PDF Chat	Bias Modelling in Evidence Synthesis	2008	Rebecca M. Turner David J. Spiegelhalter Gordon C. S. Smith Simon G. Thompson	1
+	A Bayesian approach to evaluating net clinical benefit allowed for parameter uncertainty	2005	Alex J. Sutton Nicola J. Cooper Keith R. Abrams Paul C. Lambert David R. Jones	1
+ PDF Chat	A tutorial on propensity score estimation for multiple treatments using generalized boosted models	2013	Daniel F. McCaffrey Beth Ann Griffin Daniel Almirall Mary Ellen Slaughter Rajeev Ramchand Lane F. Burgette	1
+	I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy	2009	AD Barker C C Sigman Kelloff Gj NM Hylton DA Berry L. Esserman	1
+	A Checklist for Retrospective Database Studies—Report of the ISPOR Task Force on Retrospective Databases	2003	Brenda R. Motheral John M. Brooks Mary Ann Clark William H. Crown Peter Davey Dave Hutchins Bradley C. Martin Paul Stang	1
+ PDF Chat	Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models	2012	Brian P. Hobbs Daniel J. Sargent Bradley P. Carlin	1