Clinical Trials

Article	Citations
Stakeholder views about the responsibilities of principal investigators in multicenter randomized controlled trials	61
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials	47
Topic-specific living databases of clinical trials: A scoping review of public databases	41
Rethinking intercurrent events in defining estimands for tuberculosis trials	36
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	28
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	27
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	24
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	22
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	22
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	22
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	22
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	21
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	21
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	21
Characterization of studies considered and required under Medicare’s coverage with evidence development program	20
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	19
Training the next generation of clinical trial biostatisticians	18
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–2024	18
Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell di	17
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)	17
Bayesian analysis in confirmatory clinical trials: A narrative review and discussion of current practice	17
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	17
Evaluating the use of text-message reminders and personalised text-message reminders on the return of participant questionnaires in trials, a systematic review and meta-analysis	16
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	14
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	14

A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension	14
When is it impractical to ask informed consent? A systematic review	14
Covariate adjustment in randomized trials: An overview	13
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	12
Over-accrual in Bayesian adaptive trials with continuous futility stopping	12
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	12
Assessing the current utilization status of wearable devices in clinical research	12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	12
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials	11
Sample size estimation for the averted events ratio	11
Reconsidering stepped wedge cluster randomized trial designs with implementation periods: Fewer sequences or the parallel-group design with baseline and implementation periods are potentially more eff	10
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries	10
Commentary: Multi-stage consent for time-sensitive clinical trials	10
What influences trust in and understanding of clinical trials? An analysis of information and communication technology use and online health behavior from the Health Information National Trends Survey	9
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	9
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	9
The evolution of Data and Safety Monitoring Boards	9
Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study	8
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	8
The symbolic two-step method applied to cancer care delivery research: Safeguarding against designing an underpowered cluster randomized trial with a continuous outcome by accounting for the imprecisi	8
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	8
Proceedings of the University of Pennsylvania 17th annual conference on statistical issues in clinical trials: Covariate adjustment in randomized clinical trials: new methods and applications	8
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	8
Payments for research participation: Don’t tax the Guinea pig	8
Sequential monitoring of time-to-event safety endpoints in clinical trials	8
Response	8
The Support, Educate, Empower personalized glaucoma coaching trial design	8
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	7
Adjusting for covariates in randomized clinical trials for drugs and biological products	7
Estimating clinical trial hazard functions	7
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	7
A hybrid automated event adjudication system for clinical trials	7
Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–2024	7
Book Review – For the common good	7
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	7
A hybrid approach to comparing parallel-group and stepped-wedge cluster-randomized trials with a continuous primary outcome when there is uncertainty in the intra-cluster correlation	7
Reconsidering registration requirements for trials randomising health care providers	7
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study	6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	6
Optimizing the doses of cancer drugs after usual dose finding	6
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	6
Desirability of outcome ranking (DOOR) analysis for multivariate survival outcomes with application to ACTT-1 trial	6
Salvaging information from paused or stopped clinical studies	6
In-Conference Workshop	6
Estimands in clinical trials of complex disease processes	6
Causal interpretation of the hazard ratio in randomized clinical trials	6
The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review	6
Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes	6
Now is the time to fix the evidence generation system	6

Covariate adjustment in randomized controlled trials: General concepts and practical considerations	6
Shaping the future of clinical trials through strategic foresight	5
Public involvement in Australian clinical trials: A systematic review	5
Commentary on van Lancker et al	5
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	5
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study	5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	5
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial	5
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	5
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints	5
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	5
Developing a research coordinator workforce: A case study of a hospital and university collaboration	5
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	5
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	5
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	5
Estimating treatment effects in trials with outcome data truncated by death: A case study on aligning estimators with estimands	4
Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project	4
Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet data-adaptive learning	4
The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia	4
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	4
A randomized study comparing patient portal and email communications for trial recruitment	4
Afternoon discussion: Statistical issues in clinical trials conference on dose finding	4
A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials	4
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	4
Optimising adherence to inpatient rehabilitation trial protocols: A mixed-methods systematic review	4
Implementing a suicide risk management protocol as part of a multisite clinical trial: Findings and lessons learned	4
An open-source SQL database schema for integrated clinical and translational data management in clinical trials	4
Defining estimand for the win ratio: Separate the true effect from censoring	4
Factors associated with enrollment in a randomized clinical trial of docosahexaenoic supplementation in toddlers born preterm	4
Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project	4
Overall average treatment effects from clinical trials, one-variable-at-a-time subgroup analyses and predictive approaches to heterogeneous treatment effects: Toward a more patient-centered evidence-b	4
From the ASPREE investigators: Response to Wittes et al.	4
When should factorial designs be used for late-phase randomised controlled trials?	4
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	4
Statistical approaches for component-wise censored composite endpoints	3
Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies	3
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	3
Approaches to ensure quality of information provision and consent processes for vaccine clinical trial participation in Sub-Saharan Africa: A scoping review	3
Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study	3
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	3
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	3
The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States	3
Analysis of adaptive platform trials using a network approach	3
Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies	3
Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines	3
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study	3
Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the	3
A single item for overall side effect impact: Association with clinician-reported adverse events and global health	3
Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study	3
Overview of modern approaches for identifying and evaluating heterogeneous treatment effects from clinical data	3
Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study	3
Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials	3
Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaborati	3
Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 study	3
Taking clinical decisions seriously in standard-of-care pragmatic clinical trials	3
Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV	3
Strategies to promote contraception use by female volunteers in Alzheimer’s Prevention Initiative Autosomal-Dominant Alzheimer’s Disease (API ADAD) Colombia trial	3
The impact of feedback training on prediction of cancer clinical trial results	2
Comparing meta-analysis and linear mixed model-based approaches for the analysis of continuous outcomes from batched stepped wedge trials	2
Experiences with recruitment and retention of adolescents and emerging adults in a weight loss intervention trial	2
A survey on UK researchers’ views regarding their experiences with the de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets	2
Abstracts from the Society for Clinical Trials 46th Annual Meeting (2025)	2
Development and pilot validation of a novel disfigurement severity scale for plexiform neurofibromas in children with neurofibromatosis type 1	2
14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (afternoon panel discussion)	2
A comparison of different population-level summary measures for randomised trials with time-to-event outcomes, with a focus on non-inferiority trials	2
Hierarchical Bayesian modeling of heterogeneous outcome variance in cluster randomized trials	2
Adaptive promising zone design for sequential parallel comparison design with continuous outcomes	2
Minimisation for the design of parallel cluster-randomised trials: An evaluation of balance in cluster-level covariates and numbers of clusters allocated to each arm	2
Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple	2
Causal inference in randomized trials with partial clustering	2
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	2
Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial	2
Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes	2
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	2
Additional crossovers in cluster randomised crossover trials do not always increase statistical power	2
Poster Presentations	2
Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology	2
Central statistical monitoring in clinical trial management: A scoping review	2

Network methods and design of randomized trials: Application to investigation of COVID-19 vaccination boosters	2
Subgroup analyses and pre-specification	2
The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials	2
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	2
The use of linked administrative data in Australian randomised controlled trials: A scoping review	2
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	2
Considerations for identifying the “right” subgroup in adaptive enrichment trials	2
Practical inference for a complier average causal effect in cluster randomised trials with a binary outcome	2
Seamless monotherapy-combination phase I dose-escalation model-based design	2
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen	2
Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial	2
Proceedings of the University of Pennsylvania 15th annual conference on statistical issues in clinical trials: Advances in time-to-event analyses in clinical trials—challenges and opportunities	1
Composite endpoints in COVID-19 randomized controlled trials: a systematic review	1
Building a professionally recognised clinical trial workforce: Is it time for an education and accreditation strategy?	1
A review of patient recruitment in randomised controlled trials of preoperative exercise	1
A note on rank-preserving structural failure time models to account for crossover	1
Charting the content of data monitoring committee charters for clinical trials	1
Response to Cleland and Anzar	1
Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial	1
Covariate-constrained randomization with cluster selection and substitution	1
Bringing data monitoring committee charters into the sunlight	1
Confidence interval estimation for the win probability in cluster randomized trials with hierarchical composite endpoints using win fractions	1
Ethics challenges in sharing data from pragmatic clinical trials	1
A framework for sequential monitoring of individual N-of-1 trials and combining results across a series of sequentially monitored N-of-1 trials	1
Session Proposals	1
Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials—Challenges and opportunities	1
Ethical considerations for sharing aggregate results from pragmatic clinical trials	1
Scoping review of family caregiver roles in cancer clinical trial decision-making	1
Design considerations for randomized comparisons of neoadjuvant–adjuvant versus adjuvant-only cancer immunotherapy when tumor measurement schedules do not align (SWOG S1801)	1
Comment on: Shaping the future of clinical trials through strategic foresight	1
Bayesian design and analysis of two-arm cluster randomised trials using assurance: Extension to binary outcomes and comparison of Markov chain Monte Carlo and Integrated Nested Laplace Approximations	1
Adaptive phase I–II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies	1
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials	1
Abstracts from the society for clinical trials 44th annual meeting (2023)	1
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies	1
Electronic common technical document submission with analysis using R	1
15th Annual University of Pennsylvania conference on statistical issues in clinical trial/advances in time-to-event analyses in clinical trials (afternoon panel discussion)	1
Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review	1
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	1
Successful completion of large, low-cost randomized cancer trials at an academic cancer center	1
Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study	1
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	1
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials	1
Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition	1
An introduction to spillover effects in cluster randomized trials with noncompliance	1
Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness	1
From RAGs to riches: Utilizing large language models to write documents for clinical trials	1
Leveraging generative AI to transform statistical analysis plan authoring in clinical trials	1
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	1
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research	1
2024 Peer Reviewers	1
Mild-to-moderate depressive symptoms impact on self-reported outcome measures in clinical trials for neurodegenerative diseases	1
Statistical properties of items and summary scores from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ®	1
Adjudication of cause of death in older adults: Learnings for death certification from the ASPirin in Reducing Events in the Elderly study	1
Using the Delphi process to determine the minimum clinically important effect size for the Balanced-2 randomised controlled trial	1
Comment on “Causal interpretation of the hazard ratio in randomized clinical trials” by Fay and Li	1
Dose optimization for cancer treatments with considerations for late-onset toxicities	1
Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation	1
Meta-analytic evaluation of surrogate endpoints at multiple time points in randomized controlled trials with time-to-event endpoints	1
Now is the time to fix the clinical research workforce crisis	1
Detecting irregularities in randomized controlled trials using machine learning	1
On the proposed use of a finite-population correction factor in clinical trials	1
Society for Clinical Trials Data Monitoring Committee initiative website: Closing the gap	1
Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment	1
Examining the bias-efficiency tradeoff from incorporation of nonconcurrent controls in platform trials: A simulation study example from the adaptive COVID-19 treatment trial	1
On flexible covariate adjustment under covariate-constrained randomization	1