OOIR: Observatory of International Research

Papers

(The TQCC of Clinical Trials is 5. 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 2022-06-01 to 2026-06-01.)

Article	Citations
Stakeholder views about the responsibilities of principal investigators in multicenter randomized controlled trials	64
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	47
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	43
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	41
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	28
Topic-specific living databases of clinical trials: A scoping review of public databases	28
Rethinking intercurrent events in defining estimands for tuberculosis trials	24
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	23
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials	23
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	22
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	22
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial	21
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	20
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–2024	19
Characterization of studies considered and required under Medicare’s coverage with evidence development program	19
Training the next generation of clinical trial biostatisticians	19
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	19
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	17
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies	17
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)	16
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	15
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment	15
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data	14
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	14
Bayesian analysis in confirmatory clinical trials: A narrative review and discussion of current practice	14

When is it impractical to ask informed consent? A systematic review	13
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	12
Over-accrual in Bayesian adaptive trials with continuous futility stopping	12
A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension	12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	12
Sample size estimation for the averted events ratio	12
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials	11
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	11
Assessing the current utilization status of wearable devices in clinical research	11
Adaptive trial design and interim decision-making using incomplete longitudinal measurements: Methods and application to myasthenia gravis	10
Covariate adjustment in randomized trials: An overview	10
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	10
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	9
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries	9
Commentary: Multi-stage consent for time-sensitive clinical trials	9
The evolution of Data and Safety Monitoring Boards	8
Payments for research participation: Don’t tax the Guinea pig	8
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	8
Sequential monitoring of time-to-event safety endpoints in clinical trials	8
Response	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
Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study	8
Proceedings of the University of Pennsylvania 17th annual conference on statistical issues in clinical trials: Covariate adjustment in randomized clinical trials: new methods and applications	8
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
Analysis of composite time-to-event endpoints in cardiovascular outcome trials	7
Reconsidering registration requirements for trials randomising health care providers	7
Adjusting for covariates in randomized clinical trials for drugs and biological products	7
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	7
The Support, Educate, Empower personalized glaucoma coaching trial design	7
Estimating clinical trial hazard functions	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
A hybrid automated event adjudication system for clinical trials	7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	7
Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes	6
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study	6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	6
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	6
Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–2024	6
Salvaging information from paused or stopped clinical studies	6
Desirability of outcome ranking (DOOR) analysis for multivariate survival outcomes with application to ACTT-1 trial	6
Causal interpretation of the hazard ratio in randomized clinical trials	6
Trial informed consent forms, the Declaration of Helsinki and the SPIRIT 2025 statement	6
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	6
The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review	6
Book Review – For the common good	6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	5
Estimands in clinical trials of complex disease processes	5
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	5

Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints	5
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	5
In-Conference Workshop	5
Optimizing the doses of cancer drugs after usual dose finding	5
Developing a research coordinator workforce: A case study of a hospital and university collaboration	5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	5
Public involvement in Australian clinical trials: A systematic review	5
Now is the time to fix the evidence generation system	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
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)	5
Shaping the future of clinical trials through strategic foresight	5