OOIR: Observatory of International Research

Papers

(The TQCC of Clinical Trials is 4. 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 2021-06-01 to 2025-06-01.)

Article	Citations
Rethinking intercurrent events in defining estimands for tuberculosis trials	42
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	33
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	30
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	23
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	23
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	23
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	22
Random effect misspecification in stepped wedge designs	21
Effects of patient-reported outcome assessment order	21
What do we do with our under-enrolled single-center COVID-19 clinical trials?	21
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	19
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	19
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries	18
Characterization of studies considered and required under Medicare’s coverage with evidence development program	16
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	15
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	15
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	15
Influential methods reports for group-randomized trials and related designs	15
Practical steps to identifying the research risk of pragmatic trials	14
Reply to Quartagno et al.	13
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	13
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
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

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
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	11
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	11
Joint testing of overall and simple effects for the two-by-two factorial trial design	10
Over-accrual in Bayesian adaptive trials with continuous futility stopping	10
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	10
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	10
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	10
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries	9
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens	9
The evolution of Data and Safety Monitoring Boards	9
Assessing the current utilization status of wearable devices in clinical research	9
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	8
Response	8
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	8
Interim data monitoring in cluster randomised trials: Practical issues and a case study	8
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	8
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	8
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	8
Sequential monitoring of time-to-event safety endpoints in clinical trials	8
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	8
A hybrid automated event adjudication system for clinical trials	7
The Support, Educate, Empower personalized glaucoma coaching trial design	7
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	7
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
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
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
Payments for research participation: Don’t tax the Guinea pig	7
Book Review – For the common good	7
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	6
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	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
Causal interpretation of the hazard ratio in randomized clinical trials	6
Can quality management drive evidence generation?	6
Estimands in clinical trials of complex disease processes	6
In-Conference Workshop	6
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	6
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	6
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	5
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	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
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm	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
Now is the time to fix the evidence generation system	5
Optimizing the doses of cancer drugs after usual dose finding	5

Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	5
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	5
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	4
Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry	4
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	4
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials	4
Defining estimand for the win ratio: Separate the true effect from censoring	4
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	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
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial	4
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment	4
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	4
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints	4
A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials	4
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review	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
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials	4
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism	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
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	4
Commentary on van Lancker et al	4
Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project	4
Overview of modern approaches for identifying and evaluating heterogeneous treatment effects from clinical data	4
Application of tetrad testing to the evaluation of blinding strategies for ancillary supplies used in controlled clinical trials	4
Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials	4
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent	4
Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently	4
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	4
Public involvement in Australian clinical trials: A systematic review	4