Clinical Trials

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 2022-05-01 to 2026-05-01.)
ArticleCitations
Stakeholder views about the responsibilities of principal investigators in multicenter randomized controlled trials61
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials47
Topic-specific living databases of clinical trials: A scoping review of public databases41
Rethinking intercurrent events in defining estimands for tuberculosis trials36
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges28
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials27
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry24
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials22
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial22
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”22
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials22
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials21
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial21
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies21
Characterization of studies considered and required under Medicare’s coverage with evidence development program20
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience19
Training the next generation of clinical trial biostatisticians18
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–202418
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)17
Bayesian analysis in confirmatory clinical trials: A narrative review and discussion of current practice17
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey17
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 di17
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-analysis16
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment14
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data14
A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension14
When is it impractical to ask informed consent? A systematic review14
Covariate adjustment in randomized trials: An overview13
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma12
Over-accrual in Bayesian adaptive trials with continuous futility stopping12
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters12
Assessing the current utilization status of wearable devices in clinical research12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov12
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials11
Sample size estimation for the averted events ratio11
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 eff10
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries10
Commentary: Multi-stage consent for time-sensitive clinical trials10
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 Survey9
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions9
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review9
The evolution of Data and Safety Monitoring Boards9
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time8
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 imprecisi8
Analysis of composite time-to-event endpoints in cardiovascular outcome trials8
Proceedings of the University of Pennsylvania 17th annual conference on statistical issues in clinical trials: Covariate adjustment in randomized clinical trials: new methods and applications8
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt8
Payments for research participation: Don’t tax the Guinea pig8
Sequential monitoring of time-to-event safety endpoints in clinical trials8
Response8
The Support, Educate, Empower personalized glaucoma coaching trial design8
Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study8
Adjusting for covariates in randomized clinical trials for drugs and biological products7
Estimating clinical trial hazard functions7
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination7
A hybrid automated event adjudication system for clinical trials7
Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–20247
Book Review – For the common good7
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study7
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 correlation7
Reconsidering registration requirements for trials randomising health care providers7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?7
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study6
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–20226
Optimizing the doses of cancer drugs after usual dose finding6
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)6
Desirability of outcome ranking (DOOR) analysis for multivariate survival outcomes with application to ACTT-1 trial6
Salvaging information from paused or stopped clinical studies6
In-Conference Workshop6
Estimands in clinical trials of complex disease processes6
Causal interpretation of the hazard ratio in randomized clinical trials6
The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review6
Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes6
Now is the time to fix the evidence generation system6
Covariate adjustment in randomized controlled trials: General concepts and practical considerations6
Commentary on van Lancker et al5
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations5
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials5
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial5
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study5
Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials5
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints5
Developing a research coordinator workforce: A case study of a hospital and university collaboration5
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events5
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent5
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri5
An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism5
Shaping the future of clinical trials through strategic foresight5
Public involvement in Australian clinical trials: A systematic review5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)5
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