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 2022-07-01 to 2026-07-01.)

Article	Citations
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry	65
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial	49
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”	46
Topic-specific living databases of clinical trials: A scoping review of public databases	44
Rethinking intercurrent events in defining estimands for tuberculosis trials	31
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges	28
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials	25
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials	24
Stakeholder views about the responsibilities of principal investigators in multicenter randomized controlled trials	23
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials	22
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials	21
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials	21
Characterization of studies considered and required under Medicare’s coverage with evidence development program	21
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience	20
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–2024	19
Training the next generation of clinical trial biostatisticians	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	17
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey	16
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
Bayesian analysis in confirmatory clinical trials: A narrative review and discussion of current practice	14
Adaptive trial design and interim decision-making using incomplete longitudinal measurements: Methods and application to myasthenia gravis	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
Covariate adjustment in randomized trials: An overview	13
When is it impractical to ask informed consent? A systematic review	13
A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension	12
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma	12
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters	12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov	11
Over-accrual in Bayesian adaptive trials with continuous futility stopping	11
Sample size estimation for the averted events ratio	11
Assessing the current utilization status of wearable devices in clinical research	10
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials	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	9
Commentary: Multi-stage consent for time-sensitive clinical trials	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
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review	8
Payments for research participation: Don’t tax the Guinea pig	8
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt	8
The evolution of Data and Safety Monitoring Boards	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	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
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions	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
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time	7
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	7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?	7
Desirability of outcome ranking (DOOR) analysis for multivariate survival outcomes with application to ACTT-1 trial	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
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination	7
Estimating clinical trial hazard functions	7
The Support, Educate, Empower personalized glaucoma coaching trial design	7
A hybrid automated event adjudication system for clinical trials	7
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study	7
Book Review – For the common good	6
Accounting for non-adherence: A re-analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results trial	6
Causal interpretation of the hazard ratio in randomized clinical trials	6
Salvaging information from paused or stopped clinical studies	6
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study	6
The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review	6
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials	6
Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–2024	6
Reconsidering registration requirements for trials randomising health care providers	6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022	6
Adjusting for covariates in randomized clinical trials for drugs and biological products	6
Trial informed consent forms, the Declaration of Helsinki and the SPIRIT 2025 statement	6
Estimands in clinical trials of complex disease processes	5
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)	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

Optimizing the doses of cancer drugs after usual dose finding	5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials	5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations	5
In-Conference Workshop	5
Covariate adjustment in randomized controlled trials: General concepts and practical considerations	5
Shaping the future of clinical trials through strategic foresight	5
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri	5
Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes	5
Now is the time to fix the evidence generation system	5
Developing a research coordinator workforce: A case study of a hospital and university collaboration	5
Phase I design for partially ordered groups with late-onset toxicity	5