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 2021-05-01 to 2025-05-01.)

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
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	18
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	18
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries	17
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	16
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
Practical steps to identifying the research risk of pragmatic trials	14
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	14
Reply to Quartagno et al.	14
When is it impractical to ask informed consent? A systematic review	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
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
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
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
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
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
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