Clinical Trials

Article	Citations
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials	54
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	42
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	27
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	26
Random effect misspecification in stepped wedge designs	25
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	25
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	25
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	23
Effects of patient-reported outcome assessment order	23
Rethinking intercurrent events in defining estimands for tuberculosis trials	20
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	19
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	19
Training the next generation of clinical trial biostatisticians	19
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	18
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	17
Characterization of studies considered and required under Medicare’s coverage with evidence development program	17
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–2024	16
Influential methods reports for group-randomized trials and related designs	15
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	15
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)	14
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	14
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	14
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	13
Practical steps to identifying the research risk of pragmatic trials	13
Assessing the current utilization status of wearable devices in clinical research	13

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	13
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	13
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	13
When is it impractical to ask informed consent? A systematic review	13
Over-accrual in Bayesian adaptive trials with continuous futility stopping	13
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials	12
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	12
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	12
The evolution of Data and Safety Monitoring Boards	10
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	10
Sample size estimation for the averted events ratio	10
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries	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	10
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	10
Sequential monitoring of time-to-event safety endpoints in clinical trials	10
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	9
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	9
A hybrid automated event adjudication system for clinical trials	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
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	8
The Support, Educate, Empower personalized glaucoma coaching trial design	8
Book Review – For the common good	8
Response	8
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	8
Salvaging information from paused or stopped clinical studies	8
Payments for research participation: Don’t tax the Guinea pig	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
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	8
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	7
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	7
Causal interpretation of the hazard ratio in randomized clinical trials	7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	7
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	7
In-Conference Workshop	6
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study	6
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	6
Optimizing the doses of cancer drugs after usual dose finding	6
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study	6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	6
Now is the time to fix the evidence generation system	6
Developing a research coordinator workforce: A case study of a hospital and university collaboration	6
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	6
Can quality management drive evidence generation?	6
Estimands in clinical trials of complex disease processes	6
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs	6
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	6
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	6
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	5
Afternoon discussion: Statistical issues in clinical trials conference on dose finding	5

A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials	5
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test	5
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	5
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	5
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	5
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	5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	5
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	5
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	5
Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project	5
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints	5
Public involvement in Australian clinical trials: A systematic review	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
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	4
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	4
Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project	4
The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia	4
From the ASPREE investigators: Response to Wittes et al.	4
Approaches to ensure quality of information provision and consent processes for vaccine clinical trial participation in Sub-Saharan Africa: A scoping review	4
Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study	4
Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials	4
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	4
An open-source SQL database schema for integrated clinical and translational data management in clinical trials	4
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	4
Estimating treatment effects in trials with outcome data truncated by death: A case study on aligning estimators with estimands	4
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	4
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	4
When should factorial designs be used for late-phase randomised controlled trials?	4
Statistical approaches for component-wise censored composite endpoints	4
Recruiting an underserved, difficult to reach population into a cancer trial: Strategies from the Restore-2 Rehabilitation Trial for gay and bisexual prostate cancer patients	4
Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaborati	4
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations	4
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	4
A randomized study comparing patient portal and email communications for trial recruitment	4
Commentary on van Lancker et al	4
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	4
Overview of modern approaches for identifying and evaluating heterogeneous treatment effects from clinical data	4
Defining estimand for the win ratio: Separate the true effect from censoring	4
Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies	4
Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines	4
Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies	4
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	3
14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (afternoon panel discussion)	3
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study	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
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
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	3
A comparison of different population-level summary measures for randomised trials with time-to-event outcomes, with a focus on non-inferiority trials	3
Considerations for identifying the “right” subgroup in adaptive enrichment trials	3
Development and pilot validation of a novel disfigurement severity scale for plexiform neurofibromas in children with neurofibromatosis type 1	3
Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 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
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	3
Large-scale prevention trials could provide stronger evidence for decision-makers: Opportunities to design and report with a focus on the benefit–harm balance	3
Seamless monotherapy-combination phase I dose-escalation model-based design	3
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	3
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	3
Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial	3
Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study	3
Taking clinical decisions seriously in standard-of-care pragmatic clinical trials	3
Strategies to promote contraception use by female volunteers in Alzheimer’s Prevention Initiative Autosomal-Dominant Alzheimer’s Disease (API ADAD) Colombia trial	3
Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study	3
Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention	3
Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes	3
Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial	2
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials	2
Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review	2
Subgroup analyses and pre-specification	2
Experiences with recruitment and retention of adolescents and emerging adults in a weight loss intervention trial	2
Causal inference in randomized trials with partial clustering	2
Practical inference for a complier average causal effect in cluster randomised trials with a binary outcome	2
Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple	2
Hierarchical Bayesian modeling of heterogeneous outcome variance in cluster randomized trials	2
Comment on “Causal interpretation of the hazard ratio in randomized clinical trials” by Fay and Li	2
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen	2
Adaptive phase I–II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies	2
Protecting blinded trials in electronic hospital systems	2
Adaptive promising zone design for sequential parallel comparison design with continuous outcomes	2

The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials	2
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	2
The use of linked administrative data in Australian randomised controlled trials: A scoping review	2
Poster Presentations	2
Network methods and design of randomized trials: Application to investigation of COVID-19 vaccination boosters	2
The impact of feedback training on prediction of cancer clinical trial results	2
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research	2
Building a professionally recognised clinical trial workforce: Is it time for an education and accreditation strategy?	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
Central statistical monitoring in clinical trial management: A scoping review	2
Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology	2
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	2
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	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	2
Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment	1
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials	1
Covariate-constrained randomization with cluster selection and substitution	1
Society for Clinical Trials Data Monitoring Committee initiative website: Closing the gap	1
Ethics challenges in sharing data from pragmatic clinical trials	1
Incorporating data from multiple ongoing trials for Bayesian two-stage phase II single-arm studies	1
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies	1
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	1
Meta-analytic evaluation of surrogate endpoints at multiple time points in randomized controlled trials with time-to-event endpoints	1
Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials—Challenges and opportunities	1
Dose optimization for cancer treatments with considerations for late-onset toxicities	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
Bringing data monitoring committee charters into the sunlight	1
From RAGs to riches: Utilizing large language models to write documents for clinical trials	1
Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness	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
Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial	1
Time trends with response-adaptive randomization: The inevitability of inefficiency	1
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials	1
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	1
Scoping review of family caregiver roles in cancer clinical trial decision-making	1
Abstracts from the society for clinical trials 44th annual meeting (2023)	1
Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study	1
Randomization: Beyond the closurization principle	1
Now is the time to fix the clinical research workforce crisis	1
Response to Cleland and Anzar	1
Session Proposals	1
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials	1
On the proposed use of a finite-population correction factor in clinical trials	1
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model	1
Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition	1
Electronic common technical document submission with analysis using R	1
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	1
Clinical Trials to authors: Please pre-register your studies!	1
Some drawbacks of variable-weight composite endpoints	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
Composite endpoints in COVID-19 randomized controlled trials: a systematic review	1
Adjudication of cause of death in older adults: Learnings for death certification from the ASPirin in Reducing Events in the Elderly study	1
Detecting irregularities in randomized controlled trials using machine learning	1
A review of patient recruitment in randomised controlled trials of preoperative exercise	1
Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation	1
Bayesian basket trial design with false-discovery rate control	1
Successful completion of large, low-cost randomized cancer trials at an academic cancer center	1
Design considerations for randomized comparisons of neoadjuvant–adjuvant versus adjuvant-only cancer immunotherapy when tumor measurement schedules do not align (SWOG S1801)	1
Statistical properties of items and summary scores from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ® ) in	1
Ethical considerations for sharing aggregate results from pragmatic clinical trials	1
2024 Peer Reviewers	1