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 2020-05-01 to 2024-05-01.)

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)	75
Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial	53
Non-adjustment for multiple testing in multi-arm trials of distinct treatments: Rationale and justification	49
Endpoints for randomized controlled clinical trials for COVID-19 treatments	48
Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials	25
COVID-19 vaccine trials: The use of active controls and non-inferiority studies	23
Use of electronic recruitment methods in a clinical trial of adults with gout	22
User-centered design principles in the development of clinical research tools	21
The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials	20
Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial	20
Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials	19
Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods	19
Summarising salient information on historical controls: A structured assessment of validity and comparability across studies	18
Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff	18
Characteristics of available studies and dissemination of research using major clinical data sharing platforms	16
Commentary on Parker and Weir	15
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)	15
Mindfulness, Education, and Exercise for age-related cognitive decline: Study protocol, pilot study results, and description of the baseline sample	15
Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000–2019: A review and meta-analytic approach	14
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018	13
An ethics framework for consolidating and prioritizing COVID-19 clinical trials	13
Retrospective collection of 90-day modified Rankin Scale is accurate	13
Incorporating estimands into clinical trial statistical analysis plans	13
The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date	13
Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study	12

The DURATIONS randomised trial design: Estimation targets, analysis methods and operating characteristics	12
Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?	12
Randomized comparison of two interventions to enhance understanding during the informed consent process for research	12
Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial	12
Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial	11
Strategies for research participant engagement: A synthetic review and conceptual framework	11
Clarifying selection bias in cluster randomized trials	11
Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool	11
Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis	11
Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality	10
When is it impractical to ask informed consent? A systematic review	10
Now is the time to fix the evidence generation system	10
Five analytic challenges in working with electronic health records data to support clinical trials with some solutions	9
A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease	9
Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned	9
Now is the time to fix the clinical research workforce crisis	9
Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review	9
Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification	9
Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment	9
The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials	8
Research Attitudes Questionnaire scores predict Alzheimer’s disease clinical trial dropout	8
Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer	8
Influential methods reports for group-randomized trials and related designs	8
COVID-19 impact on multi-site recruitment and enrollment	8
The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States	7
Exploring factors influencing recruitment results of nurses recruiting diabetes patients for a randomized controlled trial	7
Are restricted mean survival time methods especially useful for noninferiority trials?	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
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events	7
Rethinking intercurrent events in defining estimands for tuberculosis trials	7
Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model	7
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	7
Details of risk–benefit communication in informed consent documents for phase I/II trials	7
A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats	7
Lack of harmonization of coronavirus disease ordinal scales	7
Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review	7
Patient accrual and understanding of informed consent in a two-stage consent design	7
The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks	6
Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review	6
Adjusting for adherence in randomized trials when adherence is measured as a continuous variable: An application to the Lipid Research Clinics Coronary Primary Prevention Trial	6
Recruiting breast cancer patients for mHealth research: Obstacles to clinic-based recruitment for a mobile phone app intervention study	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
Why restricted mean survival time methods are especially useful for non-inferiority trials	6
Improving efficiency in the stepped-wedge trial design via Bayesian modeling with an informative prior for the time effects	6
Clinical trials in a COVID-19 pandemic: Shared infrastructure for continuous learning in a rapidly changing landscape	6
Quantification of hematoma and perihematomal edema volumes in intracerebral hemorrhage study: Design considerations in an artificial intelligence validation (QUANTUM) study	6
The triple aim of clinical research	6
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)	6
Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention	6
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials	5

Comparison of survival distributions in clinical trials: A practical guidance	5
The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health	5
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	5
Exploring mechanisms of action in clinical trials of complex surgical interventions using mediation analysis	5
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial	5
Reopening schools safely in the face of COVID-19: Can cluster randomized trials help?	5
Navigating the ethics of remote research data collection	5
Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources	5
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers	5
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement	5
The maraca plot: A novel visualization of hierarchical composite endpoints	5
Time trends with response-adaptive randomization: The inevitability of inefficiency	5
Making a distinction between data cleaning and central monitoring in clinical trials	5
Facilitating clinical research through automation: Combining optical character recognition with natural language processing	5
A Bayesian response-adaptive dose-finding and comparative effectiveness trial	5
Data monitoring committee interim reports: We must get there soon!	5
Joint testing of overall and simple effects for the two-by-two factorial trial design	5
Cost-benefit of outcome adjudication in nine randomised stroke trials	5
Ethics challenges in sharing data from pragmatic clinical trials	5
Analysis of adaptive platform trials using a network approach	4
Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions	4
From screening to ascertainment of the primary outcome using electronic health records: Challenges in the STRIDE trial	4
Interim data monitoring in cluster randomised trials: Practical issues and a case study	4
A modular framework for early-phase seamless oncology trials	4
Clinical trials in the time of a pandemic	4
Proceedings of the University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records (EHR) in randomized clinical trials—Challenges and opportunitie	4
Data management in substance use disorder treatment research: Implications from data harmonization of National Institute on Drug Abuse-funded randomized controlled trials	4
Use of information criteria for selecting a correlation structure for longitudinal cluster randomised trials	4
Barriers to uptake of the hip fracture core outcome set: An international survey of 80 hip fracture trialists	4
When and how to include vulnerable subjects in clinical trials	4
Backfilling cohorts in phase I dose-escalation studies	4
Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials	4
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	4
Choosing and changing the analysis scale in non-inferiority trials with a binary outcome	4
Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach	4
Measures of fidelity of delivery and engagement in self-management interventions: A systematic review of measures	4
Clinical Trials to authors: Please pre-register your studies!	4
Bayesian basket trial design with false-discovery rate control	4
Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption	4
Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register	4