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 2020-11-01 to 2024-11-01.)

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
Characteristics of available studies and dissemination of research using major clinical data sharing platforms	19
Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods	19
Strategies for research participant engagement: A synthetic review and conceptual framework	18
Now is the time to fix the clinical research workforce crisis	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
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
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
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	13
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
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
Influential methods reports for group-randomized trials and related designs	10
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
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
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
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
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
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
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
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
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
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
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
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
Bringing data monitoring committee charters into the sunlight	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
Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom	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
Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption	4