Clinical Trials

Article	Citations
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	49
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	32
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	25
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	24
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	24
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	24
Effects of patient-reported outcome assessment order	23
Random effect misspecification in stepped wedge designs	22
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials	21
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	21
Rethinking intercurrent events in defining estimands for tuberculosis trials	21
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	21
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries	18
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	17
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	17
Influential methods reports for group-randomized trials and related designs	16
Characterization of studies considered and required under Medicare’s coverage with evidence development program	16
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	16
Reply to Quartagno et al.	15
Practical steps to identifying the research risk of pragmatic trials	15
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	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
Stratified randomization for platform trials with differing experimental arm eligibility	12
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial	12
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	12

Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	12
Over-accrual in Bayesian adaptive trials with continuous futility stopping	11
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	11
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)	11
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	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
Assessing the current utilization status of wearable devices in clinical research	11
Joint testing of overall and simple effects for the two-by-two factorial trial design	11
When is it impractical to ask informed consent? A systematic review	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
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens	10
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	10
The evolution of Data and Safety Monitoring Boards	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
Sequential monitoring of time-to-event safety endpoints in clinical trials	9
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	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
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	8
Response	8
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	8
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	8
A hybrid automated event adjudication system for clinical trials	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
The Support, Educate, Empower personalized glaucoma coaching trial design	7
Salvaging information from paused or stopped clinical studies	7
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	7
Payments for research participation: Don’t tax the Guinea pig	7
Book Review – For the common good	7
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	7
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	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
Causal interpretation of the hazard ratio in randomized clinical trials	7
In-Conference Workshop	6
Optimizing the doses of cancer drugs after usual dose finding	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)	6
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	6
Can quality management drive evidence generation?	6
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	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
Developing a research coordinator workforce: A case study of a hospital and university collaboration	5
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	5
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	5
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs	5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	5
Estimands in clinical trials of complex disease processes	5
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test	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

Now is the time to fix the evidence generation system	5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	5
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	5
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	5
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	5
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	5
Commentary on van Lancker et al	4
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	4
Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaborati	4
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	4
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	4
Application of tetrad testing to the evaluation of blinding strategies for ancillary supplies used in controlled clinical trials	4
Public involvement in Australian clinical trials: A systematic review	4
A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials	4
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints	4
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	4
Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project	4
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	4
Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies	4
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	4
From the ASPREE investigators: Response to Wittes et al.	4
When should factorial designs be used for late-phase randomised controlled trials?	4
The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia	4
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	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
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	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
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials	4
Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials	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
An open-source SQL database schema for integrated clinical and translational data management in clinical trials	4
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	4
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	4
Afternoon discussion: Statistical issues in clinical trials conference on dose finding	4
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	4
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	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	3
Abstracts from the SCT 42nd annual meeting (2021)	3
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	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
Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial	3
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	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
Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies	3
Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study	3
Taking clinical decisions seriously in standard-of-care pragmatic clinical trials	3
Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study	3
Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 study	3
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study	3
Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines	3
Statistical approaches for component-wise censored composite endpoints	3
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations	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 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
Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study	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
Approaches to ensure quality of information provision and consent processes for vaccine clinical trial participation in Sub-Saharan Africa: A scoping review	3
Poster Presentations	2
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	2
Considerations for identifying the “right” subgroup in adaptive enrichment trials	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
Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology	2
Causal inference in randomized trials with partial clustering	2
The impact of feedback training on prediction of cancer clinical trial results	2
Protecting blinded trials in electronic hospital systems	2
Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial	2
The use of linked administrative data in Australian randomised controlled trials: A scoping review	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
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	2
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	2
Development and pilot validation of a novel disfigurement severity scale for plexiform neurofibromas in children with neurofibromatosis type 1	2
Why restricted mean survival time methods are especially useful for non-inferiority trials	2
Adaptive promising zone design for sequential parallel comparison design with continuous outcomes	2
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen	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

The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform 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
Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes	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
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	2
Hierarchical Bayesian modeling of heterogeneous outcome variance in cluster randomized trials	2
Seamless monotherapy-combination phase I dose-escalation model-based design	2
Building a professionally recognised clinical trial workforce: Is it time for an education and accreditation strategy?	2
Network methods and design of randomized trials: Application to investigation of COVID-19 vaccination boosters	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
Simulation-based design of pragmatic trials in psoriatic arthritis using propensity scores	2
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research	2
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	2
Abstracts from the society for clinical trials 44th annual meeting (2023)	1
Bayesian basket trial design with false-discovery rate control	1
Bringing data monitoring committee charters into the sunlight	1
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies	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
Electronic common technical document submission with analysis using R	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
On the proposed use of a finite-population correction factor in clinical trials	1
Randomization: Beyond the closurization principle	1
Using the Delphi process to determine the minimum clinically important effect size for the Balanced-2 randomised controlled trial	1
Time trends with response-adaptive randomization: The inevitability of inefficiency	1
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	1
From RAGs to riches: Utilizing large language models to write documents for clinical trials	1
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial	1
Commentary on Price and Scott: Complex innovative trial design	1
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials	1
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model	1
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials	1
Ethical considerations for sharing aggregate results from pragmatic clinical trials	1
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	1
Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment	1
Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition	1
Experiences with recruitment and retention of adolescents and emerging adults in a weight loss intervention trial	1
Now is the time to fix the clinical research workforce crisis	1
2024 Peer Reviewers	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
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials	1
Clinical Trials to authors: Please pre-register your studies!	1
Composite endpoints in COVID-19 randomized controlled trials: a systematic review	1
Design considerations for randomized comparisons of neoadjuvant–adjuvant versus adjuvant-only cancer immunotherapy when tumor measurement schedules do not align (SWOG S1801)	1
Covariate-constrained randomization with cluster selection and substitution	1
Successful completion of large, low-cost randomized cancer trials at an academic cancer center	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
Ethics challenges in sharing data from pragmatic 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
A review of patient recruitment in randomised controlled trials of preoperative exercise	1
Comment on “Causal interpretation of the hazard ratio in randomized clinical trials” by Fay and Li	1
Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness	1
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials	1
Central statistical monitoring in clinical trial management: A scoping review	1
Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial	1
Society for Clinical Trials Data Monitoring Committee initiative website: Closing the gap	1
Dose optimization for cancer treatments with considerations for late-onset toxicities	1
Cost-effective clinical trial design: Application of a Bayesian sequential model to the ProFHER pragmatic trial	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
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome	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
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	1
Session Proposals	1
Detecting irregularities in randomized controlled trials using machine learning	1