Clinical Trials

A randomized evaluation of on-site monitoring nested in a multinational randomized trial

Improving pragmatic clinical trial design using real-world data

Beware of on-treatment safety analyses

Open science: The open clinical trials data journey

Defining treatment effects: A regulatory perspective

Bayesian clinical trials at The University of Texas MD Anderson Cancer Center: An update

The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies

Generalizing the per-protocol treatment effect: The case of ACTG A5095

Design and monitoring of survival trials based on restricted mean survival times

Stepped-wedge trials should be classified as research for the purpose of ethical review

Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial

Commentary on Engen et al: Risk-based, dynamic, process-oriented monitoring strategies and their burden

Commentary on King-Kallimanis et al.: Inadequate measurement of symptomatic adverse events in immunotherapy registration trials

Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States

Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes

Proceedings of the University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies

A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial

Noninferiority trials with nonadherence to the assigned randomized treatment

Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials

Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study

Commentary on Ji et al: Sub-optimal illustration of response adaptive randomization

A readily available improvement over method of moments for intra-cluster correlation estimation in the context of cluster randomized trials and fitting a GEE–type marginal model for binary outcomes

Merged block randomisation: A novel randomisation procedure for small clinical trials.

Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program

Transparency and objectivity in governance of clinical trials data sharing: Current practices and approaches

Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews

Recommendations for improving clinical trial design to facilitate the study of youth-onset type 2 diabetes

Nonparticipation reasons in a randomized international trial of a new latent tuberculosis infection regimen

Abstract CT220: Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer

Use of telephone and web interfaces of interactive response technology at clinical investigator sites in clinical trials

The ethical relevance of two types of adverse health effects on research bystanders as applied to HIV, mosquito bednet and organ transplant trials

Risk to bystanders in clinical trials: A symposium

Exploring the roots of clinical trial methodology in medieval Islamic medicine

Cluster randomised trials with different numbers of measurements at baseline and endline: Sample size and optimal allocation

Investigational drug labeling variability

Sex partners as bystanders in HIV prevention trials: Two test cases for research ethics

Abstract CT192: Entrectinib in locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer (NSCLC): Integrated analysis of ALKA-372-001, STARTRK-1 and STARTRK-2

Rejoinder

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study

Organ donor intervention trials and the ethical challenge of bystander organ recipients

Abstract B13: Pilot trial of gemcitabine, nab-paclitaxel, metformin, and a standardized dietary supplement in patients with unresectable pancreatic cancer

Regulating impact on bystanders in clinical trials: An unsettled frontier

Commentary on Hay et al.: Can clinical trials data collection be improved by administrative data elements?

Abstract B58: A phase I/II study of durvalumab and stereotactic radiotherapy in locally advanced pancreatic cancer

Creation of an institutional semi-independent data monitoring committee