OOIR: Observatory of International Research

Papers

(The median citation count of Clinical Trials is 1. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-04-01 to 2025-04-01.)

Article	Citations
Impact of correlation structure on sample size requirements of statistical methods for multiple binary outcomes: A simulation study	40
Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy	31
A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial	29
Abstracts from the Society for Clinical Trials 45th Annual Meeting (2024)	23
Ethics challenges in sharing data from pragmatic clinical trials	22
Clinical trials in Russia	21
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	21
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	20
Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom	20
Inferences for the distribution of the duration of response in a comparative clinical study	20
Research encouraging off-label use of quetiapine: A systematic meta-epidemiological analysis	19
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	18
On the proposed use of a finite-population correction factor in clinical trials	18
Statistical approaches for component-wise censored composite endpoints	17
What do we do with our under-enrolled single-center COVID-19 clinical trials?	16
Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials	15
Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design	15
Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial	15
Analysis of adaptive platform trials using a network approach	14
Effects of patient-reported outcome assessment order	14
Bringing data monitoring committee charters into the sunlight	14
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	14
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster randomized clinical trials—opportunities and challenges (morning panel session)	13
Successful completion of large, low-cost randomized cancer trials at an academic cancer center	12
Dynamic use of historical controls in clinical trials for rare disease research: A re-evaluation of the MILES trial	12

Contributed Presentations	12
Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial	11
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	10
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	10
Session Proposals	10
Commentary on Price and Scott: Complex innovative trial design	10
The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States	9
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	9
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	9
Book Review – For the common good	9
Are self-reported and self-monitored adherence good proxies for reaching relevant plasma concentrations?: Experiences from a study of anti-depressants in healthy volunteers	9
Dose optimization for cancer treatments with considerations for late-onset toxicities	9
Abstracts from the society for clinical trials 44th annual meeting (2023)	9
Using multistate models with clinical trial data for a deeper understanding of complex disease processes	9
Causal interpretation of the hazard ratio in randomized clinical trials	8
Rethinking intercurrent events in defining estimands for tuberculosis trials	8
A model for conducting clinical trials via telemedicine	8
Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation	8
Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial	7
Now is the time to fix the clinical research workforce crisis	7
Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines	7
Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment	7
Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials	7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	7
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	7
Random effect misspecification in stepped wedge designs	7
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	6
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	6
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	6
Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register	6
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test	6
Considerations for open-label randomized clinical trials: Design, conduct, and analysis	6
Time trends with response-adaptive randomization: The inevitability of inefficiency	6
Cost-effective clinical trial design: Application of a Bayesian sequential model to the ProFHER pragmatic trial	6
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	6
Society for Clinical Trials Data Monitoring Committee initiative website: Closing the gap	6
Improving data monitoring in Australian clinical trials and research: Free resources and templates	6
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	6
Randomization: Beyond the closurization principle	5
An example of implementing a safety protocol in remote intervention and survey research with college students	5
Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project	5
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome	5
Taking clinical decisions seriously in standard-of-care pragmatic clinical trials	5
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	5
Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study	5
2023 Peer Reviewers	5
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support	5
Large-scale prevention trials could provide stronger evidence for decision-makers: Opportunities to design and report with a focus on the benefit–harm balance	5
The Targeted Agent and Profiling Utilization Registry Study: A pragmatic clinical trial	5
Commentary on Aschmann et al: How do we incorporate harms in analyses of randomized trials?	5

Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study	4
The net benefit for time-to-event outcome in oncology clinical trials with treatment switching	4
Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials	4
Strategies to promote contraception use by female volunteers in Alzheimer’s Prevention Initiative Autosomal-Dominant Alzheimer’s Disease (API ADAD) Colombia trial	4
A Bayesian dose-finding design for outcomes evaluated with uncertainty	4
Characterization of studies considered and required under Medicare’s coverage with evidence development program	4
Proceedings of the University of Pennsylvania 14th annual conference on statistical issues in clinical trials: Subgroup analysis in randomized clinical trials—Challenges and opportunities	4
2024 Peer Reviewers	4
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	4
Now is the time to fix the evidence generation system	4
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical 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
Optimizing the doses of cancer drugs after usual dose finding	4
Can quality management drive evidence generation?	4
Estimands in clinical trials of complex disease processes	4
Adaptive Bayesian information borrowing methods for finding and optimizing subgroup-specific doses	4
Commentary on Chirkova et al.: Some comments on “socialist pharmapolitics”	4
Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 study	4
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs	4
Influential methods reports for group-randomized trials and related designs	4
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	3
Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption	3
A review of patient recruitment in randomised controlled trials of preoperative exercise	3
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study	3
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	3
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	3
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	3
Clarifying selection bias in cluster randomized trials	3
Bayesian basket trial design with false-discovery rate control	3
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	3
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)	3
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	3
NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants	3
Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial	3
Composite endpoints in COVID-19 randomized controlled trials: a systematic review	3
In-Conference Workshop	3
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies	3
Barriers and facilitators to the inclusion of deaf people in clinical trials	3
The triple aim of clinical research	3
Estimating counterfactual placebo HIV incidence in HIV prevention trials without placebo arms based on markers of HIV exposure	3
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	3
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	3
Practical issues in operationalizing the design and outcome evaluation of cluster randomized trials	3
Optimal allocation to treatment sequences in individually randomized stepped-wedge designs with attrition	3
Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial	3
Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery	3
Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool	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
Considerations for identifying the “right” subgroup in adaptive enrichment trials	2
The maraca plot: A novel visualization of hierarchical composite endpoints	2
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment	2
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	2
Reply to Quartagno et al.	2
Stratified randomization for platform trials with differing experimental arm eligibility	2
Navigating the ethics of remote research data collection	2
Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes	2
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	2
Minimization of resource utilization data collected within cost-effectiveness analyses conducted alongside Canadian Cancer Trials Group phase III trials	2
New strategies for confirmatory testing of secondary hypotheses on combined data from multiple trials	2
Shedding light on data monitoring committee charters on ClinicalTrials.gov	2
Patient-reported measures of tinnitus for individuals with neurofibromatosis type 2–related schwannomatosis: Recommendations for clinical trials	2
Statistical and practical considerations in planning and conduct of dose-optimization trials	2
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	2
Comparison of Bayesian and frequentist monitoring boundaries motivated by the Multiplatform Randomized Clinical Trial	2
Commentary on Toerper et al: A step in the right direction for learning health systems	2
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	2
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	2
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)	2
Commentary on Astrachan et al. The transmutation of research risk in pragmatic clinical trials	2
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial	2
Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial	2
Facilitating clinical research through automation: Combining optical character recognition with natural language processing	2
Are pragmatism and ethical protections in clinical trials a zero-sum game?	2
Development and pilot validation of a novel disfigurement severity scale for plexiform neurofibromas in children with neurofibromatosis type 1	2
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018	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
A framework for sequential monitoring of individual N-of-1 trials and combining results across a series of sequentially monitored N-of-1 trials	2
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	2
Data monitoring committee interim reports: We must get there soon!	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

Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention	2
Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials—Challenges and opportunities	2
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	2
Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program: A cross-sectional analysis	2
2021 Peer Reviewers	2
Exclusion of people from oncology clinical trials based on functional status	2
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance	2
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	1
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial	1
Recruitment characteristics of randomised trials in critical care: A systematic review	1
Improving efficiency in the stepped-wedge trial design via Bayesian modeling with an informative prior for the time effects	1
Rejoinder to Dr Vickers	1
Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review	1
Strategies for research participant engagement: A synthetic review and conceptual framework	1
An introduction to spillover effects in cluster randomized trials with noncompliance	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
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	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
Mobilizing the clinical trial ecosystem to drive adoption of master protocols	1
Multiply robust estimation of principal causal effects with noncompliance and survival outcomes	1
Rethinking the clinical research protocol: Lessons learned from the COVID-19 pandemic and recommendations for reducing noncompliance	1
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens	1
A survey of patients with laryngotracheal stenosis on future clinical trial design	1
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	1
Over-accrual in Bayesian adaptive trials with continuous futility stopping	1
Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient	1
When is it impractical to ask informed consent? A systematic review	1
15th Annual University of Pennsylvania conference on statistical issues in clinical trial/advances in time to event analyses in clinical trials (morning panel discussion)	1
Characteristics of available studies and dissemination of research using major clinical data sharing platforms	1
Use of Epic^® to facilitate high-quality randomization of emergency department-based pragmatic clinical trials	1
Detecting irregularities in randomized controlled trials using machine learning	1
Practical steps to identifying the research risk of pragmatic trials	1
Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey	1
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	1
Clinical Trials to authors: Please pre-register your studies!	1
Commentary on van Lancker et al	1
Backfilling cohorts in phase I dose-escalation studies	1
Assessing the current utilization status of wearable devices in clinical research	1
A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials	1
Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers	1
Why restricted mean survival time methods are especially useful for non-inferiority trials	1
Hierarchical Bayesian modeling of heterogeneous outcome variance in cluster randomized trials	1
Adapting international clinical trials during COVID-19 and beyond	1
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	1
The use of linked administrative data in Australian randomised controlled trials: A scoping review	1
Estimating treatment effects from a randomized controlled trial with mid-trial design changes	1
Public involvement in Australian clinical trials: A systematic review	1
Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?	1
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	1
Accrual Quality Improvement Program for clinical trials	1
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials	1
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	1
Advanced analytics for clinical trial quality: Commentary on ‘Can quality management drive evidence generation?’	1
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	1
Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022	1
Joint testing of overall and simple effects for the two-by-two factorial trial design	1
A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic	1
Is it reasonable to label a trial as pragmatic whose investigators do not? The UK RECOVERY COVID-19 trial case	1
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	1
Covariate-constrained randomization with cluster selection and substitution	1
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	1
Incorporating estimands into clinical trial statistical analysis plans	1
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials	1
Poster Presentations	1
A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial	1