All Stories

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