All Stories

  1. On the Inclusion of Non‐Concurrent Controls in Platform Trials With an Interim Analysis
  2. Graph Based, Adaptive, Multiarm, Multiple Endpoint, Two‐Stage Designs
  3. Design Considerations for a Phase II Platform Trial in Major Depressive Disorder
  4. Treatment-Control Comparisons in Platform Trials Including Non-Concurrent Controls
  5. Statistical Modeling to Adjust for Time Trends in Adaptive Platform Trials Utilizing Non‐Concurrent Controls
  6. Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape
  7. Transforming the evidence landscape in mental health with platform trials
  8. A Comparison of Statistical Methods for Time‐To‐Event Analyses in Randomized Controlled Trials Under Non‐Proportional Hazards
  9. Efficiency of multivariate tests in trials in progressive supranuclear palsy
  10. Rejoinder
  11. Resuscitative endovascular balloon occlusion of the aorta for trauma patients with uncontrolled hemorrhage: a retrospective target trial emulation (the AT-REBOA target trial)
  12. Intensive care unit caseload and workload and their association with outcomes in critically unwell patients: a large registry-based cohort analysis
  13. Evaluation of the Fill-it-up-design to use historical control data in randomized clinical trials with two arm parallel group design
  14. A low-noise always-on interference-robust 125kHz key fob wake-up receiver
  15. A general consonance principle for closure tests based on p-values
  16. 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)
  17. Quantitative Comparisons of Progressive Supranuclear Palsy Rating Scale Versions Using Item Response Theory
  18. Innovative approaches for vaccine trials as a key component of pandemic preparedness – a white paper
  19. Methods for non-proportional hazards in clinical trials: A systematic review
  20. Regulatory Issues of Platform Trials: Learnings from EU‐PEARL
  21. Optimal allocation strategies in platform trials with continuous endpoints
  22. Simultaneous inference procedures for the comparison of multiple characteristics of two survival functions
  23. Red blood cell transfusion-related dynamics of extracellular vesicles in intensive care patients: a prospective subanalysis
  24. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL
  25. Using Randomization Tests to Address Disruptions in Clinical Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
  26. Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults ≥75 years (EU-COVAT-1)
  27. The impact of religion on changes in end-of-life practices in European intensive care units: a comparative analysis over 16 years
  28. Statistical Considerations in Pediatric Cancer Trials: Report of American Statistical Association Biopharmaceutical Section Open Forum Discussions
  29. Are early post‐discharge physician contacts associated with 30‐day psychiatric re‐hospitalisation? A nationwide claims data based retrospective cohort study in Austria free of immortal time bias
  30. Comparing maximum diameter and volume when assessing the growth of small abdominal aortic aneurysms using longitudinal CTA data: cohort study
  31. NCC: An R-package for analysis and simulation of platform trials with non-concurrent controls
  32. Vaccine Development during a Pandemic: General Lessons for Clinical Trial Design
  33. On the use of non-concurrent controls in platform trials: a scoping review
  34. Nationwide analysis of hospital admissions and outcomes of patients with SARS-CoV-2 infection in Austria in 2020 and 2021
  35. Online error rate control for platform trials
  36. Red blood cell transfusion-related eicosanoid profiles in intensive care patients—A prospective, observational feasibility study
  37. Review article: The need for more efficient and patient‐oriented drug development pathways in NASH—setting the scene for platform trials
  38. Designing Dose-Optimization Studies in Cancer Drug Development: Discussions with Regulators
  39. Implementing clinical trial data sharing requires training a new generation of biomedical researchers
  40. Association of immediate versus delayed extubation of patients admitted to intensive care units postoperatively and outcomes: A retrospective study
  41. Immunogenicity and Reactogenicity of a First Booster with NT162b2or Full-Dose mRNA-1273: A Randomised VACCELERATE Trial in Adults ≥75 Years (EU-COVAT-1)
  42. Immunogenicity, Reactogenicity and Safety of a Second Booster with BNT162b2 or Full-Dose mRNA-1273: A Randomised VACCELERATE Trial in Adults ≥75 Years (EU-COVAT-1-AGED Part B)
  43. Optimal designs for the development of personalized treatment rules
  44. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network
  45. Online control of the False Discovery Rate in group-sequential platform trials
  46. Impact of adaptive filtering on power and false discovery rate in RNA-seq experiments
  47. Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment
  48. Cancer Clinical Trials beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
  49. STUDY PROTOCOL A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): A trial conducted within the VACC...
  50. Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption
  51. On model-based time trend adjustments in platform trials with non-concurrent controls
  52. Testing and Interpreting the “Right” Hypothesis—Comment on “Non-proportional Hazards — An Evaluation of the MaxCombo Test in Cancer Clinical Trials”
  53. Rationale for the update algorithm of the graphical approach to sequentially rejective multiple test procedures
  54. Incidence and Outcomes of Cardiopulmonary Resuscitation in ICUs: Retrospective Cohort Analysis
  55. Validation of bedside ultrasound to predict lumbar muscle area in the computed tomography in 200 non-critically ill patients: The USVALID prospective study
  56. Estimands and Complex Innovative Designs
  57. Statistical advising: Professional development opportunities for the biostatistician
  58. Sex Differences in Kidney Transplantation: Austria and the United States, 1978–2018
  59. Platform trials and the future of evaluating therapeutic behavioural interventions
  60. Assessment of tumour-agnostic therapies in basket trials
  61. Robust group sequential designs for trials with survival endpoints and delayed response
  62. Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics
  63. Growth prediction model for abdominal aortic aneurysms
  64. Variations in end-of-life practices in intensive care units worldwide (Ethicus-2): a prospective observational study
  65. An international comparison of age and sex dependency of COVID-19 deaths in 2020: a descriptive analysis
  66. Analysis of the specificity of a COVID-19 antigen test in the Slovak mass testing program
  67. Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
  68. How reliably can ultrasound help determine muscle and adipose tissue thickness in clinical settings? An assessment of intra- and inter-examiner reliability in the USVALID study
  69. Association of Acute Kidney Injury Receiving Kidney Replacement Therapy With Prognosis of Critically Ill Patients With and Without Cancer: A Retrospective Study
  70. The impact of the SARS‐CoV‐2 pandemic on the ongoing prospective, international, multicentre observational study assessing the preoperative anaemia prevalence in surgical patients (ALICE‐trial)
  71. Evaluation and calibration of SAPS 3 in patients with COVID-19 admitted to intensive care units
  72. Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
  73. The use of external controls: To what extent can it currently be recommended?
  74. Optimizing subgroup selection in two‐stage adaptive enrichment and umbrella designs
  75. Collaborative Platform Trials to Fight COVID‐19: Methodological and Regulatory Considerations for a Better Societal Outcome
  76. An international comparison of age and sex dependency of COVID-19 Deaths in 2020 - a descriptive analysis
  77. Factors associated with physician decision making on withholding cardiopulmonary resuscitation in prehospital medicine
  78. Analysis of the specificity of the SD Biosensor Standard Q Ag-Test based on Slovak mass testing data
  79. Are p-values Useful to Judge the Evidence Against the Null Hypotheses in Complex Clinical Trials? A Comment on ”The Role of p-values in Judging the Strength of Evidence and Realistic Replication Expectations”
  80. Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic
  81. Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios
  82. Delayed treatment effects, treatment switching and heterogeneous patient populations: How to design and analyze RCTs in oncology
  83. Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19
  84. Analysis of Austrian COVID-19 deaths by age and sex
  85. The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review
  86. Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials
  87. Optimized multiple testing procedures for nested sub-populations based on a continuous biomarker
  88. Testing Procedures for Claiming Success on at Least k Out of m Hypotheses with an Application to Biosimilar Development
  89. A critical review of graphics for subgroup analyses in clinical trials
  90. A multiple comparison procedure for dose‐finding trials with subpopulations
  91. Simultaneous inference for multiple marginal generalized estimating equation models
  92. Time of Day and its Association with Risk of Death and Chance of Discharge in Critically Ill Patients: A Retrospective Study
  93. Quantitative approaches underpinning decision making
  94. Response to comments on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharm Stat 17(5):593-606, Sep/Oct 2018., DOI: https://doi.org/10.1002/pst.1873
  95. Nested combination tests with a time‐to‐event endpoint using a short‐term endpoint for design adaptations
  96. Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency
  97. Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
  98. Applicability and added value of novel methods to improve drug development in rare diseases
  99. Recent advances in methodology for clinical trials in small populations: the InSPiRe project
  100. Subgroup identification in clinical trials via the predicted individual treatment effect
  101. Design and estimation in clinical trials with subpopulation selection
  102. A proposal for a new PhD level curriculum on quantitative methods for drug development
  103. Methods for the analysis of multiple endpoints in small populations: A review
  104. Flexible alpha allocation strategies for confirmatory adaptive enrichment clinical trials with a prespecified subgroup
  105. Statistical analysis of Goal Attainment Scaling endpoints in randomised trials
  106. Robustness of testing procedures for confirmatory subpopulation analyses based on a continuous biomarker
  107. Optimal exact tests for multiple binary endpoints
  108. Value of information methods to design a clinical trial in a small population to optimise a health economic utility function
  109. Marketing authorisation of orphan medicines in Europe from 2000 to 2013
  110. Approaches to sample size calculation for clinical trials in rare diseases
  111. Optimized adaptive enrichment designs
  112. A Randomized Trial of Bortezomib in Late Antibody-Mediated Kidney Transplant Rejection
  113. Weekends affect mortality risk and chance of discharge in critically ill patients: a retrospective study in the Austrian registry for intensive care
  114. Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)
  115. Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from the aggregate analysis of clinicaltrials.gov
  116. “Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
  117. Estimation after blinded sample size reassessment
  118. Optimizing Trial Designs for Targeted Therapies
  119. Multi-arm group sequential designs with a simultaneous stopping rule
  120. Directions for new developments on statistical design and analysis of small population group trials
  121. Determination of the optimal sample size for a clinical trial accounting for the population size
  122. Preface
  123. Fallback tests for co-primary endpoints
  124. Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions
  125. Adaptive Designs for Clinical Trials with a Time to Event Endpoint
  126. Evidence, eminence and extrapolation
  127. Maximum type I error rate inflation from sample size reassessment when investigators are blind to treatment labels
  128. Preoperative abnormalities in serum sodium concentrations are associated with higher in-hospital mortality in patients undergoing major surgery
  129. Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review
  130. Decision-theoretic designs for small trials and pilot studies: A review
  131. Sample size reassessment for a two-stage design controlling the false discovery rate
  132. MCP2013 - 8th International Conference on Multiple Comparison Procedures
  133. Adaptive designs for subpopulation analysis optimizing utility functions
  134. Adaptive graph-based multiple testing procedures
  135. Flexible Designs
  136. Flexible Designs
  137. Bridging the gap: a review of dose investigations in paediatric investigation plans
  138. Connections between permutation andt-tests: relevance to adaptive methods
  139. Sharing clinical trial data on patient level: Opportunities and challenges
  140. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients
  141. Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union
  142. Morphine Decreases Clopidogrel Concentrations and Effects
  143. Effect of intensive care after cardiac arrest on patient outcome: a database analysis
  144. Detection of epistatic effects with logic regression and a classical linear regression model
  145. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
  146. Adaptive Budgets in Clinical Trials
  147. Simultaneous confidence intervals that are compatible with closed testing in adaptive designs
  148. Flexible Designs
  149. MCP2011-The 7th international conference on multiple comparison procedures
  150. Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk-Benefit, and Support Label Claims
  151. Wideband UHF ISM-band transceiver supporting multichannel reception and DSSS modulation
  152. Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude
  153. Author's reply
  154. Bridging the gap: a review of dose-investigation studies in paediatric investigation plans
  155. Genome-wide CpG island methylation analyses in non-small cell lung cancer patients
  156. Unplanned adaptations before breaking the blind
  157. Nanoscalic silver possesses broad-spectrum antimicrobial activities and exhibits fewer toxicological side effects than silver sulfadiazine
  158. False discovery rate control in two-stage designs
  159. Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests
  160. Impact of dental implant length on early failure rates: a meta-analysis of observational studies
  161. Special Issue for Dealing with Multiplicity in Drug Development: Current State and New Directions – Guest Editors' Note
  162. Familywise Error Control in Multi-Armed Response-Adaptive Two-Stage Designs
  163. Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim
  164. Cross-platform comparison of microarray data using order restricted inference
  165. Long-term efficacy and respective potencies of botulinum toxin A and B: a randomized, double-blind study
  166. MCP2009 - 6th International Conference on Multiple Comparison Procedures
  167. Availability of Mental Health Service Providers and Suicide Rates in Austria: A Nationwide Study
  168. Availability of Mental Health Service Providers and Suicide Rates in Austria: A Nationwide Study
  169. Early postpartum hysterectomy: incidence and risk factors
  170. Skateboarding Injuries in Vienna: Location, Frequency, and Severity
  171. On the ropivacaine-reducing effect of low-dose sufentanil in intrathecal labor analgesia
  172. Post hoc power estimation in large-scale multiple testing problems
  173. Adaptive Designs and Confirmatory Hypothesis Testing
  174. Hunting for Significance With the False Discovery Rate
  175. Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology
  176. Adaptive designs for confirmatory clinical trials
  177. T cell senescence and contraction of T cell repertoire diversity in patients with chronic obstructive pulmonary disease
  178. Optimal choice of the number of treatments to be included in a clinical trial
  179. A graphical approach to sequentially rejective multiple test procedures
  180. Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double-blind study
  181. Selection and bias-Two hostile brothers
  182. Diagnostic accuracy and reliability of muscle strength and endurance measurements in patients with chronic low back pain
  183. Correction
  184. Percutaneous ethanol instillation therapy for hepatocellular carcinoma – a randomized controlled trial
  185. MCP2007 - 5th International Conference on Multiple Comparison Procedures
  186. Optimized multi-stage designs controlling the false discovery or the family-wise error rate
  187. Exact Confidence Bounds Following Adaptive Group Sequential Tests
  188. A powerful multiple testing procedure improving the Bonferroni test
  189. A Note on repeated p-values for group sequential designs
  190. Reliability and validity of the Medical Research Council (MRC) scale and a modified scale for testing muscle strength in patients with radial palsy
  191. Adaptive Dunnett tests for treatment selection
  192. Flexible Designs
  193. Vergleichende Analyse der Messwertergebnisse von zwei Dynamometern zur Messung der isokinetischen Kraft der kniegelenksbewegenden Muskulatur
  194. The scientific work of Peter Bauer
  195. Physiotherapy-Based Rehabilitation Following Disc Herniation Operation
  196. Effects of N-acetylcysteine against systemic and renal hemodynamic effects of endotoxin in healthy humans
  197. Elevated levels of interleukin-1?-converting enzyme and caspase-cleaved cytokeratin-18 in acute myocardial infarction
  198. Repeated confidence intervals for adaptive group sequential trials
  199. Flexible Designs
  200. Clinical Features, Classification and Prognosis of Migraine and Tension-Type Headache in Children and Adolescents: A Long-Term Follow-Up Study
  201. Diuretic potential of energy drinks
  202. On the efficiency of adaptive designs for flexible interim decisions in clinical trials
  203. Implant survival in mandibles of irradiated oral cancer patients
  204. Flexible Designs
  205. Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial Comparing Adjuvant Interferon Alfa and Isotretinoin With Interferon Alfa Alone in Stage IIA and IIB Melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group
  206. Attainability of boundary points under reinforcement learning
  207. Two-stage designs for experiments with a large number of hypotheses
  208. Übersetzung und psychometrische Austestung des Western-Ontario-Rotator-Cuff-Index (WORC) für den Gebrauch in deutscher Sprache
  209. Correlations between Self-Rated Fatigue with Quality of Life, and Social Participation in Viennese Outpatients Suffering from Advanced Cancer During Palliative Chemotherapy
  210. Übersetzung und psychometrische Austestung des Rotator Cuff Quality-of-Life Measure (RC-QOL) für den Gebrauch im deutschen Sprachraum
  211. Testing and estimation in flexible group sequential designs with adaptive treatment selection
  212. Long-term implant survival in the grafted maxilla: results of a 12-year retrospective study
  213. The German version of the Oxford shoulder score?cross-cultural adaptation and validation
  214. Conditional Rejection Probabilities of Student'st-test and Design Adaptations
  215. HSP-72 Expression in Pre-Transplant Donor Kidney Biopsies and Post-Transplant Outcome
  216. Rehabilitation of the severely atrophied maxilla by horseshoe Le Fort I osteotomy (HLFO)
  217. 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,Statistics in Medicine 2001;20: 3741–3751
  218. Quality of life in patients with non-metastatic differentiated thyroid cancer under thyroxine supplementation therapy
  219. Muscle Fatigue and Fatigue-Related Biomechanical Changes During a Cyclic Lifting Task
  220. Sequential Tests for Noninferiority and Superiority
  221. Factors That Influence the Duration of Splint Wear in Peripheral Nerve Lesions
  222. Impact of Pneumococcal Vaccination on Morbidity and Mortality of Geriatric Patients: A Case-Controlled Study
  223. Issues in designing flexible trials
  224. Statistical Methods for Clinical Trials. M. X. Norleans, Marcel Dekker, New York, 2001. No. of pages: 257. ISBN 0-8247-0467-3
  225. Recursive Combination Tests
  226. The SCARF Osteotomy for the Correction of Hallux Valgus Deformities
  227. Short segment stimulation of the anterior transposed ulnar nerve at the elbow
  228. Multiple Testing for Identifying Effective and Safe Treatments
  229. CROSS-CULTURAL ADAPTATION OF THE MINNESOTA LIVING WITH HEART FAILURE QUESTIONNAIRE FOR GERMAN-SPEAKING PATIENTS
  230. Flexible Two-Stage Designs: An Overview
  231. Interim Analysis and Sample Size Reassessment
  232. Load-dependence of fatigue related changes in tremor around 10 Hz
  233. Adaptive Two Stage Designs and the Conditional Error Function
  234. The efficiency of adapting aspiration levels
  235. Win–Stay, Lose–Shift Strategies for Repeated Games—Memory Length, Aspiration Levels and Noise
  236. Cycling in a stochastic learning algorithm for normal form games