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1. Efficacy and tolerability of neoadjuvant therapy with Talimogene laherparepvec in cutaneous basal cell carcinoma: a phase II trial (NeoBCC trial)

Author

Ressler, Julia Maria, Plaschka, Maud, Silmbrod, Rita, Bachmayr, Victoria, Shaw, Lisa Ellen, Silly, Thomas, Zila, Nina, Stepan, Andreas, Kusienicka, Anna, Tschandl, Philipp, Tittes, Julia, Roka, Florian, Haslik, Werner, Petzelbauer, Peter, Koenig, Franz, Kunstfeld, Rainer, Farlik, Matthias, Halbritter, Florian, Weninger, Wolfgang, and Hoeller, Christoph

Published
2025
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3. Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥75 years (EU-COVAT-1-AGED Part B)

Author

Stemler, Jannik, Yeghiazaryan, Lusine, Stephan, Christoph, Mohn, Kristin Greve-Isdahl, Carcas-Sansuan, Antonio-José, Rodriguez, Esperanza Romero, Moltó, José, Mitxeltorena, Itziar Vergara, Welte, Tobias, Zablockienė, Birutė, Akova, Murat, Bethe, Ullrich, Heringer, Sarah, Salmanton-García, Jon, Jeck, Julia, Tischmann, Lea, Zarrouk, Marouan, Cüppers, Arnd, Biehl, Lena M., Grothe, Jan, Mellinghoff, Sibylle C., Nacov, Julia A., Neuhann, Julia M., Sprute, Rosanne, Frías-Iniesta, Jesús, Negi, Riya, Gaillard, Colette, Saini, Gurvin, León, Alejandro García, Mallon, Patrick W.G., Lammens, Christine, Hotterbeekx, An, Loens, Katherine, Malhotra-Kumar, Surbhi, Goossens, Herman, Kumar-Singh, Samir, König, Franz, Posch, Martin, Koehler, Philipp, and Cornely, Oliver A.

Published
2024
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5. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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6. Early administration of remdesivir may reduce mortality in hospitalized COVID-19 patients: A propensity score matched analysis

Author

Karolyi, Mario, Kaltenegger, Lukas, Pawelka, Erich, Kuran, Avelino, Platzer, Moritz, Totschnig, David, Koenig, Franz, Hoepler, Wolfgang, Laferl, Hermann, Omid, Sara, Seitz, Tamara, Traugott, Marianna, Arthofer, Sigrun, Erlbeck, Lea, Jaeger, Stefan, Kettenbach, Alina, Assinger, Alice, Wenisch, Christoph, and Zoufaly, Alexander

Published
2022
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11. The Adaptive designs CONSORT Extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Author

ACE Consensus Group, Dimairo, Munyaradzi, Pallmann, Philip, Wason, James, Todd, Susan, Jaki, Thomas, Julious, Steven A, Mander, Adrian P, Weir, Christopher J, Koenig, Franz, Walton, Marc K, Nicholl, Jon P, Coates, Elizabeth, Biggs, Katie, Hamasaki, Toshimitsu, Proschan, Michael A, Scott, John A, Ando, Yuki, Hind, Daniel, and Altman, Douglas G

Published
2020

13. A general consonance principle for closure tests based on p -values.

Author

Zehetmayer, Sonja, Koenig, Franz, and Posch, Martin

Subjects
*NULL hypothesis, *ERROR rates, *INDEPENDENT sets, *CONSONANTS, *HYPOTHESIS
Abstract

The closure principle is a powerful approach to constructing efficient testing procedures controlling the familywise error rate in the strong sense. For small numbers of hypotheses and the setting of independent elementary p -values we consider closed tests where each intersection hypothesis is tested with a p -value combination test. Examples of such combination tests are the Fisher combination test, the Stouffer test, the Omnibus test, the truncated test, or the Wilson test. Some of these tests, such as the Fisher combination, the Stouffer, or the Omnibus test, are not consonant and rejection of the global null hypothesis does not always lead to rejection of at least one elementary null hypothesis. We develop a general principle to uniformly improve closed tests based on p -value combination tests by modifying the rejection regions such that the new procedure becomes consonant. For the Fisher combination test and the Stouffer test, we show by simulations that this improvement can lead to a substantial increase in power. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment.

Author

Roig, Marta Bofill, Melis, Guadalupe Gómez, Posch, Martin, and Koenig, Franz

Subjects
EXPERIMENTAL design, SAMPLE size (Statistics), FALSE positive error, CLINICAL trials, RANDOMIZED controlled trials
Abstract

For randomized clinical trials where a single, primary, binary endpoint would require unfeasibly large sample sizes, composite endpoints (CEs) are widely chosen as the primary endpoint. Despite being commonly used, CEs entail challenges in designing and interpreting results. Given that the components may be of different relevance and have different effect sizes, the choice of components must be made carefully. Especially, sample size calculations for composite binary endpoints depend not only on the anticipated effect sizes and event probabilities of the composite components but also on the correlation between them. However, information on the correlation between endpoints is usually not reported in the literature which can be an obstacle for designing future sound trials. We consider two-arm randomized controlled trials with a primary composite binary endpoint and an endpoint that consists only of the clinically more important component of the CE. We propose a trial design that allows an adaptive modification of the primary endpoint based on blinded information obtained at an interim analysis. Especially, we consider a decision rule to select between a CE and its most relevant component as primary endpoint. The decision rule chooses the endpoint with the lower estimated required sample size. Additionally, the sample size is reassessed using the estimated event probabilities and correlation, and the expected effect sizes of the composite components. We investigate the statistical power and significance level under the proposed design through simulations. We show that the adaptive design is equally or more powerful than designs without adaptive modification on the primary endpoint. Besides, the targeted power is achieved even if the correlation is misspecified at the planning stage while maintaining the type 1 error. All the computations are implemented in R and illustrated by means of a peritoneal dialysis trial. [ABSTRACT FROM AUTHOR]

Published
2024
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23. On the use of non-concurrent controls in platform trials: A scoping review

Author

Roig, Marta Bofill, Burgwinkel, Cora, Garczarek, Ursula, Koenig, Franz, Posch, Martin, Nguyen, Quynh, and Hees, Katharina

Subjects
Methodology (stat.ME), FOS: Computer and information sciences, Statistics - Methodology
Abstract

Platform trials gained popularity during the last few years as they increase flexibility compared to multi-arm trials by allowing new experimental arms entering when the trial already started. Using a shared control group in platform trials increases the trial efficiency compared to separate trials. Because of the later entry of some of the experimental treatment arms, the shared control group includes concurrent and non-concurrent control data. For a given experimental arm, non-concurrent controls refer to patients allocated to the control arm before the arm enters the trial, while concurrent controls refer to control patients that are randomised concurrently to the experimental arm. Using non-concurrent controls can result in bias in the estimate in case of time trends if the appropriate methodology is not used and the assumptions are not met. In this paper, we faced two main objectives. In the first, we aimed to identify the methods currently available for incorporating non-concurrent controls, clarify the key concepts and assumptions, and name the main characteristics of each method. For this purpose, we systematically searched research articles on methods to include non-concurrent controls. The second objective is to summarise the current regulatory view on non-concurrent controls to clarify the key concepts and current guidance. Therefore, we conducted a systematic search in regulatory guidelines regarding using non-concurrent controls and summarised the most relevant arguments and recommended methods. Finally, we discuss the advantages and potential caveats of using non-concurrent controls.

Published
2022

28. The Distillation of 'VISCI': Towards a Better Identification of Suicidal Inmates

Author

Frottier, Patrick, Koenig, Franz, and Seyringer, Michaela

Abstract

The "Viennese Instrument for Suicidality in Correctional Institutions" (VISCI) presented here is based on the results of a large case-control study and on research on literature examining suicide prevention in general and in the prison population in particular. The aim of this study was to validate the properties of the VISCI to differentiate between suicides and nonsuicides. The sensitivity and specificity of the VISCI was tested in the files of 55 correctional suicides, and 110 controls. VISCI differentiated well between suicides and nonsuicides. The routine administration of the VISCI may help to direct the existing professional attention to inmates with the highest need.

Published
2009
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30. Review article: The need for more efficient and patient‐oriented drug development pathways in NASH—setting the scene for platform trials.

Author

Pericàs, Juan M., Di Prospero, Nicholas A., Anstee, Quentin M., Mesenbrinck, Peter, Kjær, Mette S., Rivera‐Esteban, Jesús, Koenig, Franz, Sena, Elena, Pais, Raluca, Manzano, Ramiro, Genescà, Joan, Tacke, Frank, Ratziu, Vlad, DiProspero, Nicholas A., Kara, Leila, Meyer, Elias, Duca, Anna, Kline, Timothy, Aaes‐Jørgensen, Anders, and Balthaus, Tania

Subjects
DRUG development, NON-alcoholic fatty liver disease, DRUGGED driving, MEDICAL research, ARMS control, PHARMACEUTICAL industry
Abstract

Summary: Background and Aims: Non‐alcoholic steatohepatitis (NASH) constitutes a significant unmet medical need with a burgeoning field of clinical research and drug development. Platform trials (PT) might help accelerate drug development while lowering overall costs and creating a more patient‐centric environment. This review provides a comprehensive and nuanced assessment of the NASH clinical development landscape. Methods: Narrative review and expert opinion with insight gained during the EU Patient‐cEntric clinicAl tRial pLatforms (EU‐PEARL) project. Results: Although NASH represents an opportunity to use adaptive trial designs, including master protocols for PT, there are barriers that might be encountered owing to distinct and sometimes opposing priorities held by these stakeholders and potential ways to overcome them. The following aspects are critical for the feasibility of a future PT in NASH: readiness of the drug pipeline, mainly from large drug companies, while there is not yet an FDA/EMA‐approved treatment; the most suitable design (trial Phase and type of population, e.g., Phase 2b for non‐cirrhotic NASH patients); the operational requirements such as the scope of the clinical network, the use of concurrent versus non‐concurrent control arms, or the re‐allocation of participants upon trial adaptations; the methodological appraisal (i.e. Bayesian vs. frequentist approach); patients' needs and patient‐centred outcomes; main regulatory considerations and the funding and sustainability scenarios. Conclusions: PT represent a promising avenue in NASH but there are a number of conundrums that need addressing. It is likely that before a global NASH PT becomes a reality, 'proof‐of‐platform' at a smaller scale needs to be provided. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Online control of the False Discovery Rate in group-sequential platform trials.

Author

Zehetmayer, Sonja, Posch, Martin, and Koenig, Franz

Subjects
FALSE discovery rate, ERROR rates
Abstract

When testing multiple hypotheses, a suitable error rate should be controlled even in exploratory trials. Conventional methods to control the False Discovery Rate assume that all p -values are available at the time point of test decision. In platform trials, however, treatment arms enter and leave the trial at different times during its conduct. Therefore, the actual number of treatments and hypothesis tests is not fixed in advance and hypotheses are not tested at once, but sequentially. Recently, for such a setting the concept of online control of the False Discovery Rate was introduced. We propose several heuristic variations of the LOND procedure (significance Levels based On Number of Discoveries) that incorporate interim analyses for platform trials, and study their online False Discovery Rate via simulations. To adjust for the interim looks spending functions are applied with O'Brien-Fleming or Pocock type group-sequential boundaries. The power depends on the prior distribution of effect sizes, for example, whether true alternatives are uniformly distributed over time or not. We consider the choice of design parameters for the LOND procedure to maximize the overall power and investigate the impact on the False Discovery Rate by including both concurrent and non-concurrent control data. [ABSTRACT FROM AUTHOR]

Published
2022
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35. When and how to adjust for multiplicity in platform trials?

Author

Koenig, Franz, Bretz, Frank, Meyer, Elias, and Posch, Martin

Subjects
ddc: 610, master protocol, platform trials, multiplicity, 610 Medical sciences, Medicine
Abstract

Background: In recent years there has been the rise of more flexible clinical trial designs allowing the investigation of several sub-studies within a single clinical trial platform. These types of designs are labelled with the term “master protocol”. Such trials can have both exploratory[for full text, please go to the a.m. URL], 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

Published
2021
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36. Delayed treatment effects, treatment switching and heterogeneous patient populations: design and analysis of randomized controlled trials under non-proportional hazards

Author

Ristl, Robin, Ballarini, Nicolas, Götte, Heiko, Schüler, Armin, Posch, Martin, and Koenig, Franz

Subjects
ddc: 610, maximum test, logrank test, 610 Medical sciences, Medicine, non-proportional hazards, survival analysis
Abstract

Comparing survival distributions based on censored data is in general challenging since conclusions are sought about distributions which are observed incompletely. In medical statistics, and in particular in oncology, the logrank test and the Cox model have been established as key tools, which do not[for full text, please go to the a.m. URL], 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

Published
2021
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38. On model-based time trend adjustments in platform trials with non-concurrent controls.

Author

Roig, Marta Bofill, Krotka, Pavla, Burman, Carl-Fredrik, Glimm, Ekkehard, Gold, Stefan M., Hees, Katharina, Jacko, Peter, Koenig, Franz, Magirr, Dominic, Mesenbrink, Peter, Viele, Kert, and Posch, Martin

Subjects
STANDARD deviations, FALSE positive error
Abstract

Background: Platform trials can evaluate the efficacy of several experimental treatments compared to a control. The number of experimental treatments is not fixed, as arms may be added or removed as the trial progresses. Platform trials are more efficient than independent parallel group trials because of using shared control groups. However, for a treatment entering the trial at a later time point, the control group is divided into concurrent controls, consisting of patients randomised to control when that treatment arm is in the platform, and non-concurrent controls, patients randomised before. Using non-concurrent controls in addition to concurrent controls can improve the trial's efficiency by increasing power and reducing the required sample size, but can introduce bias due to time trends.Methods: We focus on a platform trial with two treatment arms and a common control arm. Assuming that the second treatment arm is added at a later time, we assess the robustness of recently proposed model-based approaches to adjust for time trends when utilizing non-concurrent controls. In particular, we consider approaches where time trends are modeled either as linear in time or as a step function, with steps at time points where treatments enter or leave the platform trial. For trials with continuous or binary outcomes, we investigate the type 1 error rate and power of testing the efficacy of the newly added arm, as well as the bias and root mean squared error of treatment effect estimates under a range of scenarios. In addition to scenarios where time trends are equal across arms, we investigate settings with different time trends or time trends that are not additive in the scale of the model.Results: A step function model, fitted on data from all treatment arms, gives increased power while controlling the type 1 error, as long as the time trends are equal for the different arms and additive on the model scale. This holds even if the shape of the time trend deviates from a step function when patients are allocated to arms by block randomisation. However, if time trends differ between arms or are not additive to treatment effects in the scale of the model, the type 1 error rate may be inflated.Conclusions: The efficiency gained by using step function models to incorporate non-concurrent controls can outweigh potential risks of biases, especially in settings with small sample sizes. Such biases may arise if the model assumptions of equality and additivity of time trends are not satisfied. However, the specifics of the trial, scientific plausibility of different time trends, and robustness of results should be carefully considered. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Design and estimation in clinical trials with subpopulation selection

Author

Chiu, Yi‐Da, Koenig, Franz, Posch, Martin, and Jaki, Thomas

Subjects
Clinical Trials as Topic, Likelihood Functions, bias, Models, Statistical, Patient Selection, prevalence, subpopulation selection, maximum likelihood estimator, enrichment design, Sample Size, Humans, subgroup analysis, Research Articles, Research Article
Abstract

Population heterogeneity is frequently observed among patients' treatment responses in clinical trials because of various factors such as clinical background, environmental, and genetic factors. Different subpopulations defined by those baseline factors can lead to differences in the benefit or safety profile of a therapeutic intervention. Ignoring heterogeneity between subpopulations can substantially impact on medical practice. One approach to address heterogeneity necessitates designs and analysis of clinical trials with subpopulation selection. Several types of designs have been proposed for different circumstances. In this work, we discuss a class of designs that allow selection of a predefined subgroup. Using the selection based on the maximum test statistics as the worst-case scenario, we then investigate the precision and accuracy of the maximum likelihood estimator at the end of the study via simulations. We find that the required sample size is chiefly determined by the subgroup prevalence and show in simulations that the maximum likelihood estimator for these designs can be substantially biased.

Published
2018

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