Robert Hemmings

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All published works

Action	Title	Year	Authors
+	Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework	2024	Rima Izem Emmanuel Zuber Nadia Daizadeh Frank Bretz Oleksandr Sverdlov Pascal Edrich Janice Branson Evgeny Degtyarev Nikolaos Sfikas Robert Hemmings
+ PDF Chat	Decentralized clinical trials: scientific considerations through the lens of the estimand framework	2023	Rima Izem Emmanuel Zuber Nadia Daizadeh Frank Bretz Alex Sverdlov Pascal Edrich Janice Branson Evgeny Degtyarev Nikolaos Sfikas Robert Hemmings
+	The Montreal Antenatal Well-Being Study (MAWS): a prospective longitudinal study of perinatal mental health.	2023	Kelsey P Davis Cindy Hénault Robert Tina Montreuil Tuong‐Vi Nguyen Julia Barnwell Chloé Gratton Hung Viet Pham Rosemary C. Bagot Rand S. Eid Michael J. Meaney
+	Perspectives on Virtual (Remote) Clinical Trials as the “New Normal” to Accelerate Drug Development	2021	Demissie Alemayehu Robert Hemmings Kannan Natarajan Satrajit Roychoudhury
+ PDF Chat	Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials	2020	Mouna Akacha Janice Branson Frank Bretz Bharani Dharan Paul Gallo Insa Gathmann Robert Hemmings Julie Jones Dong Xi Emmanuel Zuber
+	Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials	2020	Olivier Collignon Christian Gärtner Anna‐Bettina Haidich Robert Hemmings Benjamin Hofner Frank Pétavy Martin Posch Khadija Rantell Kit C. B. Roes Anja Schiel
+ PDF Chat	Commentary on: Subgroup analysis and interpretation for phase 3 confirmatory trials: White Paper of the EFSPI/PSI working group on subgroup analysis by Dane, Spencer, Rosenkranz, Lipkovich, and Parke	2019	Robert Hemmings Armin Koch
+ PDF Chat	Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency	2018	Olivier Collignon Franz Koenig Armin Koch Robert Hemmings Frank Pétavy Agnès Saint-Raymond Marisa Papaluca‐Amati Martin Posch
+	Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)	2017	FT. Musuamba Efthymios Manolis Nicholas H. G. Holford S. Y. Amy Cheung Lena E. Friberg Kayode Ogungbenro Martin Posch JWT Yates Scott Berry Neal Thomas
+	Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials	2016	Devan V. Mehrotra Robert Hemmings Estelle Russek‐Cohen
+	Comment	2015	Robert Hemmings
+ PDF Chat	The future is now: Model‐based clinical trial design for Alzheimer's disease	2014	Klaus Romero Kaori Ito J. S. Rogers Dan Polhamus Ruolun Qiu Diane Stephenson Richard C. Mohs R L Lalonde Vikram Sinha Y Wang
+ PDF Chat	Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency	2014	Amelie Elsäßer Jan Regnström Thorsten Vetter Franz Koenig Robert Hemmings Martina Greco Marisa Papaluca‐Amati Martin Posch
+	An Overview of Statistical and Regulatory Issues in the Planning, Analysis, and Interpretation of Subgroup Analyses in Confirmatory Clinical Trials	2014	Robert Hemmings
+	The Implications of Current Methodological Issues for International Guidance	2013	Robert Hemmings John A. Lewis
+ PDF Chat	Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk–Benefit, and Support Label Claims	2013	SF Marshall Robert Hemmings Filip Josephson MO Karlsson Martin Posch J‐L Steimer
+ PDF Chat	The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop	2013	Efthymios Manolis S Rohou Robert Hemmings Tomas Salmonson Mats O. Karlsson PA Milligan
+	Missing data in clinical trials: a data interpretation problem with statistical solutions?	2011	Robert Hemmings David J. Wright
+	Discussion of the PhRMA Working Group paper on “Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations”	2010	Robert Hemmings
+	Where Statisticians can Contribute to Address Future Challenges for Drug Regulatory Agencies: A View from the European Medicines Agency (EMEA)	2010	Hans‐Georg Eichler Robert Hemmings Spiros Vamvakas
+	Discussion of “The White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs”	2007	Robert Hemmings
+	Regulatory Perspectives on Data Safety Monitoring Boards	2004	Robert Hemmings Simon Day

Common Coauthors

Coauthor	Papers Together
Martin Posch	5
Frank Bretz	4
Janice Branson	3
Emmanuel Zuber	3
Pascal Edrich	2
Evgeny Degtyarev	2
Olivier Collignon	2
Franz Koenig	2
Efthymios Manolis	2
Armin Koch	2
Marisa Papaluca‐Amati	2
Nadia Daizadeh	2
Nikolaos Sfikas	2
Spiros Vamvakas	2
Frank Pétavy	2
Rima Izem	2
Martine Goyet	1
Satrajit Roychoudhury	1
Norbert Benda	1
Luca Pani	1
S Rohou	1
Vikram Sinha	1
Neal Thomas	1
Valeria Gigante	1
John A. Lewis	1
Falk Ehmann	1
Sylvana M. Côté	1
Andrew C. Hooker	1
Michael J. Meaney	1
Ruolun Qiu	1
Kristin Karlsson	1
Christian Gärtner	1
Richard A. Brown	1
LJ Bain	1
Scott Berry	1
Brian Corrigan	1
Hannah Schwartz	1
Thorsten Vetter	1
Tuong‐Vi Nguyen	1
Tina Montreuil	1
Dong Xi	1
Anne Brochot	1
S. Y. Amy Cheung	1
Anja Schiel	1
Demissie Alemayehu	1
Estelle Russek‐Cohen	1
Deborah Da Costa	1
Thomas Dumortier	1
Kieran J. O’Donnell	1
Devan V. Mehrotra	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+ PDF Chat	Testing and estimation in flexible group sequential designs with adaptive treatment selection	2005	Martin Posch Franz Koenig Michael Branson Werner Brannath Cornelia Dunger‐Baldauf Péter Bauer	3
+	Adaptive Dunnett tests for treatment selection	2007	Franz Koenig Werner Brannath Frank Bretz Martin Posch	2
+	Adaptive Modifications of Hypotheses After an Interim Analysis	2001	Gerhard Hommel	2
+	Selection and bias—Two hostile brothers	2009	Péter Bauer Franz Koenig Werner Brannath Martin Posch	2
+ PDF Chat	Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic	2020	R. Daniel Meyer Bohdana Ratitch Marcel Wolbers Olga Marchenko Hui Quan Daniel Li Christine Fletcher Xin Li David Wright Yue Shentu	2
+	Designed Extension of Studies Based on Conditional Power	1995	Michael A. Proschan Sally Hunsberger	2
+	Evaluation of Experiments with Adaptive Interim Analyses	1994	Péter Bauer Karl Kohne	2
+	Adaptive designs for confirmatory clinical trials	2009	Frank Bretz Franz Koenig Werner Brannath Ekkehard Glimm Martin Posch	2
+	Pharmacometrics for Regulatory Decision Making	2011	Efthymios Manolis Ralf Herold	2
+ PDF Chat	Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency	2014	Amelie Elsäßer Jan Regnström Thorsten Vetter Franz Koenig Robert Hemmings Martina Greco Marisa Papaluca‐Amati Martin Posch	2
+	Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections	2001	H. Schäfer Hans‐Helge Müller	2
+	Statistical Principles for Clinical Trials	1998	Robert R. Kay	2
+ PDF Chat	What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?	2020	Rachael Lawrance Evgeny Degtyarev Philip Griffiths Peter C. Trask Helen Lau Denise D’Alessio Ingolf Griebsch G. Wallenstein Kim Cocks Kaspar Rufibach	2
+	Data Monitoring Committees in Clinical Trials: A Practical Perspective	2002	Susan S. Ellenberg Thomas R. Fleming David L. DeMets	2
+	Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials	2007	Björn Bornkamp Frank Bretz Alex Dmitrienko Greg Enas Brenda Gaydos Chyi‐Hung Hsu Franz König Michael Krams Qing Liu Beat Neuenschwander	2
+	Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections by H. Schäfer and H.‐H. Müller, <i>Statistics in Medicine</i> 2001; <b>20</b>: 3741–3751	2004	Péter Bauer Martin Posch	2
+	Statistical Issues in Drug Development	2007	Stephen Senn	2
+	Applying modeling and simulation to improve the design of a clinical efficacy trial	1999	Madeleine S. Gastonguay Helen S. Pentikis Maurice Alexander Lorraine Lee	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
+	Data Monitoring Committee	2008	Susan S. Ellenberg	1
+	Clinical Trial Simulation: A Review	2010	Nicholas H. G. Holford Subhrojyoti R.C. Bart A. Ploeger	1
+	Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts	2006	Frank Bretz Heinz Schmidli Franz König Amy Racine Willi Maurer	1
+ PDF Chat	Modeling and Simulation at the Interface of Nonclinical and Early Clinical Drug Development	2013	Sandra A. G. Visser Efthymios Manolis Meindert Danhof Thomas Kerbusch	1
+	Adaptive Two Stage Designs and the Conditional Error Function	1999	Martin Posch Péter Bauer	1
+	Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications	2005	Venkatesh Atul Bhattaram Brian Booth Roshni Ramchandani B. Nhi Beasley Yaning Wang Veneeta Tandon John Duan Raman Baweja Patrick Marroum Ramana Uppoor	1
+ PDF Chat	Adaptive and nonadaptive group sequential tests	2006	Christopher Jennison Bruce W. Turnbull	1
+ PDF Chat	A comparison of bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials	2013	James Wason Lorenzo Trippa	1
+	Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim	2010	Martin Posch Willi Maurer Frank Bretz	1
+ PDF Chat	The Prevention and Treatment of Missing Data in Clinical Trials	2012	Roderick J. A. Little Ralph B. D’Agostino Michael L. Cohen Kay Dickersin Scott S. Emerson John T. Farrar Constantine Frangakis Joseph W. Hogan Geert Molenberghs Susan A. Murphy	1
+ PDF Chat	Interim Design Modifications in Time-to-Event Studies	2012	Sebastian Irle H. Schäfer	1
+	Modern adaptive randomized clinical trials : statistical and practical aspects	2015	Oleksandr Sverdlov	1
+	Model Selection: An Integral Part of Inference	1997	S. T. Buckland Kenneth P. Burnham Nicole H. Augustin	1
+	Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials	2010	Sue‐Jane Wang Hung Hung Robert T. O’Neill	1
+ PDF Chat	The European regulatory experience	2002	John A. Lewis	1
+	Estimating the contribution of everolimus to immunosuppressive efficacy when combined with tacrolimus in liver transplantation: A model‐based approach	2015	Thomas Dumortier Michael Looby Olivier Luttringer Guenter Heimann J Klupp G. Junge S. Witte R VanValen Donald Stanski	1
+	Reliably Basing Conclusions on Subgroups of Randomized Clinical Trials	2014	Armin Koch Theodor Framke	1
+	Computer simulation of a clinical trial as an aid to teaching the concept of statistical significance	1986	John M. Bland	1
+	Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial	2015	François Mercier Bjoern Bornkamp David Ohlssen Erik Wallstroem	1
+	Generalized Additive Models: An Introduction with R, Second Edition	2017	Simon N. Wood	1
+ PDF Chat	Adaptive increase in sample size when interim results are promising: A practical guide with examples	2010	Cyrus R. Mehta Stuart J. Pocock	1
+	Optimization of Individual and Population Designs Using Splus	2003	Sylvie Retout France Mentré	1
+	Utilisation of Pharmacokinetic- Pharmacodynamic Modelling and Simulation in Regulatory Decision-Making	2001	Jogarao Gobburu Patrick Marroum	1
+	PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force	2014	Sonya Eremenco Stephen Joel Coons Jean Paty Karin S. Coyne Antonia V. Bennett Damian McEntegart	1
+	Issues in designing flexible trials	2003	Martin Posch Péter Bauer Werner Brannath	1
+	Exploring changes in treatment effects across design stages in adaptive trials	2008	Tim Friede Robin Henderson	1
+	The advantages and disadvantages of adaptive designs for clinical trials	2004	Péter Bauer Werner Brannath	1
+	Compound D- and D s -Optimum Designs for Determining the Order of a Chemical Reaction	1997	Anthony C. Atkinson Barbara Bogacka	1
+	A graphical approach to sequentially rejective multiple test procedures	2008	Frank Bretz Willi Maurer Werner Brannath Martin Posch	1
+	An Overview of Statistical and Regulatory Issues in the Planning, Analysis, and Interpretation of Subgroup Analyses in Confirmatory Clinical Trials	2014	Robert Hemmings	1
+	Combining different phases in the development of medical treatments within a single trial	1999	Péter Bauer Meinhard Kieser	1