Clinical Trials

Article	Citations
Rethinking intercurrent events in defining estimands for tuberculosis trials	42
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	32
Random effect misspecification in stepped wedge designs	30
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	23
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	23
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	22
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	21
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	21
What do we do with our under-enrolled single-center COVID-19 clinical trials?	21
Effects of patient-reported outcome assessment order	20
Influential methods reports for group-randomized trials and related designs	19
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	19
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	18
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	18
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries	17
Characterization of studies considered and required under Medicare’s coverage with evidence development program	16
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	16
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	15
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	14
Reply to Quartagno et al.	14
Practical steps to identifying the research risk of pragmatic trials	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	13
When is it impractical to ask informed consent? A systematic review	13
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial	12
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	12

Stratified randomization for platform trials with differing experimental arm eligibility	12
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	11
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	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	11
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	11
Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?	11
Joint testing of overall and simple effects for the two-by-two factorial trial design	10
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	10
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens	10
Assessing the current utilization status of wearable devices in clinical research	10
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	10
Over-accrual in Bayesian adaptive trials with continuous futility stopping	10
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	9
The evolution of Data and Safety Monitoring Boards	9
Sequential monitoring of time-to-event safety endpoints in clinical trials	9
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries	9
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	8
Interim data monitoring in cluster randomised trials: Practical issues and a case study	8
Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality	8
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	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	7
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	7
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	7
A hybrid automated event adjudication system for clinical trials	7
Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study	7
Assessing the external validity of the VALIDATE-SWEDEHEART trial	7
Payments for research participation: Don’t tax the Guinea pig	7
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	7
Response	7
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	7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	6
The Support, Educate, Empower personalized glaucoma coaching trial design	6
Can quality management drive evidence generation?	6
Book Review – For the common good	6
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	6
Causal interpretation of the hazard ratio in randomized clinical trials	6
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	6
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	5
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	5
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	5
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	5
Estimands in clinical trials of complex disease processes	5
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs	5
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	5
Now is the time to fix the evidence generation system	5
In-Conference Workshop	5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	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

Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)	5
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test	4
Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project	4
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial	4
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	4
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	4
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	4
Strategies for research participant engagement: A synthetic review and conceptual framework	4
Optimizing the doses of cancer drugs after usual dose finding	4
Public involvement in Australian clinical trials: A systematic review	4
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	4
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	4
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	4
Commentary on van Lancker et al	4
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	4
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	4
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	4
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	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
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment	4
A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials	4
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	4
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	3
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	3
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	3
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	3
Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials	3
Analysis of adaptive platform trials using a network approach	3
The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States	3
Abstracts from the SCT 42nd annual meeting (2021)	3
When should factorial designs be used for late-phase randomised controlled trials?	3
The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia	3
An open-source SQL database schema for integrated clinical and translational data management in clinical trials	3
Defining estimand for the win ratio: Separate the true effect from censoring	3
Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaborati	3
Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study	3
Statistical approaches for component-wise censored composite endpoints	3
Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach	3
Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies	3
Application of tetrad testing to the evaluation of blinding strategies for ancillary supplies used in controlled clinical trials	3
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials	3
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	3
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	3
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations	3
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	3
Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines	3
Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies	3
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	3
Overview of modern approaches for identifying and evaluating heterogeneous treatment effects from clinical data	3
Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 study	2
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	2
Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study	2
Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes	2
Network methods and design of randomized trials: Application to investigation of COVID-19 vaccination boosters	2
Subgroup analyses and pre-specification	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
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	2
Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial	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
Hierarchical Bayesian modeling of heterogeneous outcome variance in cluster randomized trials	2
Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention	2
Poster Presentations	2
Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study	2
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	2
Strategies to promote contraception use by female volunteers in Alzheimer’s Prevention Initiative Autosomal-Dominant Alzheimer’s Disease (API ADAD) Colombia trial	2
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	2
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	2
Central statistical monitoring in clinical trial management: A scoping review	2
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research	2
COVID-19 vaccine trials: The potential for “hybrid” analyses	2
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	2
Experiences with recruitment and retention of adolescents and emerging adults in a weight loss intervention trial	2
Development and pilot validation of a novel disfigurement severity scale for plexiform neurofibromas in children with neurofibromatosis type 1	2
Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology	2
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	2
Simulation-based design of pragmatic trials in psoriatic arthritis using propensity scores	2
Large-scale prevention trials could provide stronger evidence for decision-makers: Opportunities to design and report with a focus on the benefit–harm balance	2
Taking clinical decisions seriously in standard-of-care pragmatic clinical trials	2
The use of linked administrative data in Australian randomised controlled trials: A scoping review	2
Considerations for identifying the “right” subgroup in adaptive enrichment trials	2

Adaptive promising zone design for sequential parallel comparison design with continuous outcomes	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
Protecting blinded trials in electronic hospital systems	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
The impact of feedback training on prediction of cancer clinical trial results	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
The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials	2
Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial	2
Why restricted mean survival time methods are especially useful for non-inferiority trials	2
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study	2
Comment on “Causal interpretation of the hazard ratio in randomized clinical trials” by Fay and Li	1
Adaptive phase I–II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies	1
Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple	1
Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition	1
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies	1
Now is the time to fix the clinical research workforce crisis	1
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials	1
Composite endpoints in COVID-19 randomized controlled trials: a systematic review	1
An introduction to spillover effects in cluster randomized trials with noncompliance	1
Randomization: Beyond the closurization principle	1
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model	1
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial	1
Session Proposals	1
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials	1
Bringing data monitoring committee charters into the sunlight	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
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
Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment	1
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials	1
Building a professionally recognised clinical trial workforce: Is it time for an education and accreditation strategy?	1
Abstracts from the society for clinical trials 44th annual meeting (2023)	1
Ethics challenges in sharing data from pragmatic clinical trials	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
Time trends with response-adaptive randomization: The inevitability of inefficiency	1
A review of patient recruitment in randomised controlled trials of preoperative exercise	1
Ethical considerations for sharing aggregate results from pragmatic 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
From RAGs to riches: Utilizing large language models to write documents for clinical trials	1
Detecting irregularities in randomized controlled trials using machine learning	1
Commentary on Price and Scott: Complex innovative trial design	1
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	1
Design considerations for randomized comparisons of neoadjuvant–adjuvant versus adjuvant-only cancer immunotherapy when tumor measurement schedules do not align (SWOG S1801)	1
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials	1
Electronic common technical document submission with analysis using R	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
Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness	1
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen	1
Dose optimization for cancer treatments with considerations for late-onset toxicities	1
On the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes	1
2024 Peer Reviewers	1
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	1
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	1
Cost-effective clinical trial design: Application of a Bayesian sequential model to the ProFHER pragmatic trial	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
Response to Cleland and Anzar	1
Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial	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
On the proposed use of a finite-population correction factor in clinical trials	1
Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials—Challenges and opportunities	1
Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation	1
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome	1
Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data	1