Clinical Trials

Article	Citations
Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	91
The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials	30
Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials	25
COVID-19 vaccine trials: The use of active controls and non-inferiority studies	23
Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff	21
Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods	19
Characteristics of available studies and dissemination of research using major clinical data sharing platforms	19
Now is the time to fix the clinical research workforce crisis	18
Strategies for research participant engagement: A synthetic review and conceptual framework	18
Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000–2019: A review and meta-analytic approach	17
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)	17
Now is the time to fix the evidence generation system	16
When is it impractical to ask informed consent? A systematic review	15
An ethics framework for consolidating and prioritizing COVID-19 clinical trials	15
Clarifying selection bias in cluster randomized trials	14
Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality	14
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018	14
Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?	14
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	14
Randomized comparison of two interventions to enhance understanding during the informed consent process for research	13
Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool	13
Incorporating estimands into clinical trial statistical analysis plans	13
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	13
Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review	12
Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis	12

Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study	12
Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment	12
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials	11
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	11
Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification	10
A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease	10
Influential methods reports for group-randomized trials and related designs	10
Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer	9
Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review	9
Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review	9
Details of risk–benefit communication in informed consent documents for phase I/II trials	9
Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned	9
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	9
Research Attitudes Questionnaire scores predict Alzheimer’s disease clinical trial dropout	9
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	8
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	8
Rethinking intercurrent events in defining estimands for tuberculosis trials	8
Patient accrual and understanding of informed consent in a two-stage consent design	8
Measures of fidelity of delivery and engagement in self-management interventions: A systematic review of measures	8
Navigating the ethics of remote research data collection	8
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model	8
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	8
Lack of harmonization of coronavirus disease ordinal scales	8
Quantification of hematoma and perihematomal edema volumes in intracerebral hemorrhage study: Design considerations in an artificial intelligence validation (QUANTUM) study	7
Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study	7
Analysis of adaptive platform trials using a network approach	7
A Bayesian response-adaptive dose-finding and comparative effectiveness trial	7
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	7
Are restricted mean survival time methods especially useful for noninferiority trials?	7
Facilitating clinical research through automation: Combining optical character recognition with natural language processing	7
Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer	6
Ethics challenges in sharing data from pragmatic clinical trials	6
Design and analysis of group-sequential clinical trials based on a modestly weighted log-rank test in anticipation of a delayed separation of survival curves: A practical guidance	6
Backfilling cohorts in phase I dose-escalation studies	6
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)	6
Improving efficiency in the stepped-wedge trial design via Bayesian modeling with an informative prior for the time effects	6
Data management in substance use disorder treatment research: Implications from data harmonization of National Institute on Drug Abuse-funded randomized controlled trials	6
Clinical trials in a COVID-19 pandemic: Shared infrastructure for continuous learning in a rapidly changing landscape	6
Interim data monitoring in cluster randomised trials: Practical issues and a case study	6
Why restricted mean survival time methods are especially useful for non-inferiority trials	6
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial	6
The maraca plot: A novel visualization of hierarchical composite endpoints	6
Time trends with response-adaptive randomization: The inevitability of inefficiency	6
Reopening schools safely in the face of COVID-19: Can cluster randomized trials help?	6
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	6
Data monitoring committee interim reports: We must get there soon!	6
The triple aim of clinical research	6
Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach	5
Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology	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

Choosing and changing the analysis scale in non-inferiority trials with a binary outcome	5
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	5
Joint testing of overall and simple effects for the two-by-two factorial trial design	5
Bayesian basket trial design with false-discovery rate control	5
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	5
Use of information criteria for selecting a correlation structure for longitudinal cluster randomised trials	5
Overview of modern approaches for identifying and evaluating heterogeneous treatment effects from clinical data	5
Making a distinction between data cleaning and central monitoring in clinical trials	5
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	5
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	5
Bringing data monitoring committee charters into the sunlight	4
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	4
A modular framework for early-phase seamless oncology trials	4
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	4
Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register	4
Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom	4
A permutation procedure to detect heterogeneous treatment effects in randomized clinical trials while controlling the type I error rate	4
Clinical Trials to authors: Please pre-register your studies!	4
Cost-effective clinical trial design: Application of a Bayesian sequential model to the ProFHER pragmatic trial	4
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test	4
Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption	4
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations	4
Methodological standards for using the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in cancer clinical trials	4
Practical steps to identifying the research risk of pragmatic trials	4
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries	4
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	3
Optimal allocation to treatment sequences in individually randomized stepped-wedge designs with attrition	3
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	3
Considerations for open-label randomized clinical trials: Design, conduct, and analysis	3
The value of adherence information during clinical pharmaceutical trials	3
Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers	3
Optimal design of cluster randomised trials with continuous recruitment and prospective baseline period	3
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	3
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	3
Importance of incorporating quantitative imaging biomarker technical performance characteristics when estimating treatment effects	3
Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation	3
Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial	3
Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy	3
Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek	3
Using simulated infectious disease outbreaks to inform site selection and sample size for individually randomized vaccine trials during an ongoing epidemic	3
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials	3
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	3
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment	3
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	3
Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery	3
Event-specific win ratios and testing with terminal and non-terminal events	3
Are self-reported and self-monitored adherence good proxies for reaching relevant plasma concentrations?: Experiences from a study of anti-depressants in healthy volunteers	3
On the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes	3
Gene-targeted therapy for neurofibromatosis and schwannomatosis: The path to clinical trials	3
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials	3
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial	3
Stratified randomization for platform trials with differing experimental arm eligibility	3
A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial	2
Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials—Challenges and opportunities	2
Shedding light on data monitoring committee charters on ClinicalTrials.gov	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
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	2
Dynamic use of historical controls in clinical trials for rare disease research: A re-evaluation of the MILES trial	2
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	2
Network methods and design of randomized trials: Application to investigation of COVID-19 vaccination boosters	2
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	2
Mapping time use in clinical trials for vaccines against emerging infectious diseases	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
Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program: A cross-sectional analysis	2
Adapting international clinical trials during COVID-19 and beyond	2
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	2
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	2
Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitor	2
Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial	2
Alternative models and randomization techniques for Bayesian response-adaptive randomization with binary outcomes	2
Accounting for the rarity of the disease when designing clinical trials with a focus on pediatric cancers	2
The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia	2
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	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
Minimization of resource utilization data collected within cost-effectiveness analyses conducted alongside Canadian Cancer Trials Group phase III trials	2
A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial	2
Barriers and facilitators to the inclusion of deaf people in clinical trials	2
Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials	2
Effects of patient-reported outcome assessment order	2
Payments for research participation: Don’t tax the Guinea pig	2

COVID-19 vaccine trials: The potential for “hybrid” analyses	2
Design of a novel clinical trial of prehospital pediatric airway management	2
Clinician engagement in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial	2
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	2
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research	1
Can quality management drive evidence generation?	1
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	1
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	1
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	1
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	1
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	1
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster randomized clinical trials—opportunities and challenges (morning panel session)	1
An introduction to spillover effects in cluster randomized trials with noncompliance	1
A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial	1
Registration of clinical trials in Russia: How does it compare with the World Health Organization International Clinical Trials Registry Platform standards?	1
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	1
The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States	1
Electronic common technical document submission with analysis using R	1
Accrual Quality Improvement Program for clinical trials	1
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	1
Cognitive screening considerations for psychosocial clinical trials in HIV, aging, and cognition	1
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	1
A hybrid automated event adjudication system for clinical trials	1
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	1
Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple	1
Commentary on Chirkova et al.: Some comments on “socialist pharmapolitics”	1
Subgroup analyses and pre-specification	1
Data-driven strategies for increasing patient diversity in Bristol Myers Squibb–sponsored US oncology clinical trials	1
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs	1
Futility monitoring for randomized clinical trials with non-proportional hazards: An optimal conditional power approach	1
A review of patient recruitment in randomised controlled trials of preoperative exercise	1
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	1
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	1
Covariate-constrained randomization with cluster selection and substitution	1
Dose optimization for cancer treatments with considerations for late-onset toxicities	1
A comparison of computational algorithms for the Bayesian analysis of clinical trials	1
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial	1
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	1
Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation	1
Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey	1
Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial	1
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	1
Statistical and practical considerations in planning and conduct of dose-optimization trials	1
Fitness of real-world data for clinical trial data collection: Results and lessons from a HARMONY Outcomes ancillary study	1
The use of linked administrative data in Australian randomised controlled trials: A scoping review	1
Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies	1
Proceedings of the University of Pennsylvania 14th annual conference on statistical issues in clinical trials: Subgroup analysis in randomized clinical trials—Challenges and opportunities	1
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	1
Current issues in dose-finding designs: A response to the US Food and Drug Adminstration’s Oncology Center of Excellence Project Optimus	1
Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial	1
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	1
Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project	1
Potential endpoints for assessment of bone health in persons with neurofibromatosis type 1	1
The Targeted Agent and Profiling Utilization Registry Study: A pragmatic clinical trial	1
Is it reasonable to label a trial as pragmatic whose investigators do not? The UK RECOVERY COVID-19 trial case	1
Random effect misspecification in stepped wedge designs	1
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	1
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	1
Risk–benefit trade-offs and precision utilities in phase I-II clinical trials	1
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	1
What do we do with our under-enrolled single-center COVID-19 clinical trials?	1
Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness	1
Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project	1
Experience of conducting clinical trials of investigational medicinal products during a respiratory virus pandemic: Lessons learnt from COVID-19	1
Assessing the external validity of the VALIDATE-SWEDEHEART trial	1
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	1
Commentary on Kahrass et al: The sublime inertia of informed consent language in early phase clinical trials involving patients	1
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	1
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials	1
Improving data monitoring in Australian clinical trials and research: Free resources and templates	1
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen	1