All Stories

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