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 2021-11-01 to 2025-11-01.)
ArticleCitations
Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials54
Industry payments and brand-name tyrosine kinase inhibitor use amid generic entry42
Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges27
A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”26
Random effect misspecification in stepped wedge designs25
Treatment selection in multi-arm multi-stage designs: With application to a postpartum haemorrhage trial25
Perspectives of adolescents with neurofibromatosis 1 and cutaneous neurofibromas: Implications for clinical trials25
A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials23
Effects of patient-reported outcome assessment order23
Rethinking intercurrent events in defining estimands for tuberculosis trials20
Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies19
Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials19
Training the next generation of clinical trial biostatisticians19
Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial18
Characterization of studies considered and required under Medicare’s coverage with evidence development program17
A Bayesian adaptive design approach for stepped-wedge cluster randomized trials17
How is missing data handled in cluster randomized controlled trials? A review of trials published in the NIHR Journals Library 1997–202416
Importance of patient engagement in the conduct of pragmatic multicenter randomized controlled trials: The ADAPTABLE experience15
Influential methods reports for group-randomized trials and related designs15
Sixteenth Annual University of Pennsylvania conference on statistical issues in clinical trial/optimizing dose-finding across the clinical trials spectrum (morning panel discussion)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 di14
Controlling the false-discovery rate when identifying the subgroup benefiting from treatment14
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey13
Practical steps to identifying the research risk of pragmatic trials13
Assessing the current utilization status of wearable devices in clinical research13
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-analysis13
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data13
Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters13
When is it impractical to ask informed consent? A systematic review13
Over-accrual in Bayesian adaptive trials with continuous futility stopping13
Policy recommendations for implementing registries to minimize over-volunteering in Phase I clinical trials12
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 eff12
The patient perspective on dose optimization for anticancer treatments: A new era of cancer drug dosing—Challenging the “more is better” dogma12
Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov12
The evolution of Data and Safety Monitoring Boards10
Heterogeneity of surrogate outcome measures used in critical care studies: A systematic review10
Sample size estimation for the averted events ratio10
Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries10
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 Survey10
A Bayesian adaptive design for clinical trials of rare efficacy outcomes with multiple definitions10
Sequential monitoring of time-to-event safety endpoints in clinical trials10
Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement9
Scaling and interpreting treatment effects in clinical trials using restricted mean survival time9
A hybrid automated event adjudication system for clinical trials9
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
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 correlation8
Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study8
Analysis of composite time-to-event endpoints in cardiovascular outcome trials8
The Support, Educate, Empower personalized glaucoma coaching trial design8
Book Review – For the common good8
Response8
Assessing institutional responsibility in scientific misconduct: A case study of enoximone research by Joachim Boldt8
Salvaging information from paused or stopped clinical studies8
Payments for research participation: Don’t tax the Guinea pig8
Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study7
UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination7
Causal interpretation of the hazard ratio in randomized clinical trials7
Commentary on Wittes et al: Aspirin for primary prevention of CV events – Rationally robust? Statistically significant? Clinically convincing?7
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–20227
In-Conference Workshop6
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study6
BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials6
Optimizing the doses of cancer drugs after usual dose finding6
Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study6
Thirteenth annual UPenn conference on statistical issues in clinical trials: Cluster-randomized clinical trials—opportunities and challenges (afternoon panel session)6
Now is the time to fix the evidence generation system6
Developing a research coordinator workforce: A case study of a hospital and university collaboration6
The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations6
Can quality management drive evidence generation?6
Estimands in clinical trials of complex disease processes6
Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs6
Covariate adjustment in randomized controlled trials: General concepts and practical considerations6
Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri6
Public involvement in Australian clinical trials: A systematic review5
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial5
Afternoon discussion: Statistical issues in clinical trials conference on dose finding5
A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials5
Constructing and evaluating a validity argument for a performance outcome measure for clinical trials: An example using the Multi-luminance Mobility Test5
Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers5
Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events5
Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis5
Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent5
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-b5
Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials5
Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm5
Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD)5
Determining a risk-proportionate approach to the validation of statistical programming for clinical trials5
Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project5
Comparison of adaptive seamless Phase 2/3 designs for dose selection in clinical trials with multiple endpoints5
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