AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results. We recommend including DMC charters for such trials in ClinicalTrials.gov at the time of trial completion; trial protocols, informed consent documents, and statistical analysis plans are already available in this repository.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1056/EVIDctw2400058 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Adjunctive PCSK9 Inhibitor Evolocumab in the Prevention of Early Neurological Deterioration in Non-cardiogenic Acute Ischemic Stroke: A Multicenter, Prospective, Randomized, Open-Label, Clinical Trial.
CNS Drugs
January 2025
Department of Cardiology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
Background: Early neurological deterioration (END) is associated with a poor prognosis in acute ischemic stroke (AIS). Effectively lowering low-density lipoprotein cholesterol (LDL-C) can improve the stability of atherosclerotic plaque and reduce post-stroke inflammation, which may be an effective means to lower the incidence of END. The objective of this study was to determine the preventive effects of evolocumab on END in patients with non-cardiogenic AIS.
View Article and Find Full Text PDFAdministration and Monitoring Burden of High-Efficacy Disease-Modifying Therapies for Multiple Sclerosis: A Delphi Consensus of Clinical Experts from Saudi Arabia.
Neurol Ther
January 2025
InterHealth Hospital, Riyadh, Saudi Arabia.
Introduction: The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden of the therapies. This article presents the results of the Delphi consensus method to generate insights from experts on the administration and monitoring burden of HE DMT in Saudi Arabia with a special focus on cladribine.
Methods: Between January and March 2023, a two-round modified Delphi method was used to establish consensus regarding the administration and monitoring burden of HE DMTs used for MS.
Effects of urban sprawl due to migration on spatiotemporal land use-land cover change: a case study of Bartın in Türkiye.
Sci Rep
January 2025
Department of Forest Engineering, Faculty of Forestry, Kastamonu University, Kastamonu, Türkiye, Turkey.
Rapid urban growth is a subject of worldwide interest due to environmental problems. Population growth, especially migration from rural to urban areas, leads to land use and land cover (LULCC) changes in urban centres. Therefore, LULCC and urban growth analyses are among the studies that will help decision-makers achieve better sustainable management and planning.
View Article and Find Full Text PDFInflammatory markers predict efficacy of immunotherapy in advanced non-small cell lung cancer: a preliminary exploratory study.
Discov Oncol
January 2025
Department of Respiratory Medicine, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 1882 South Zhonghuan Road, Jiaxing, 314000, Zhejiang, China.
Objective: The purpose of this study is to analyze the predictive value of neutrophil to lymphocyte ratio (NLR), lymphocyte count to monocyte count ratio (LMR), platelet to lymphocyte ratio (PLR), platelet count multiplied by neutrophil count to lymphocyte count ratio (SII), red blood cell distribution width (RDW), packed cell volume (PCV), and plateletcrit (PCT) levels in advanced non-small cell lung cancer (NSCLC) patients treated with PD-1/PD-L1 inhibitors.
Materials And Methods: From March 2019 to August 2023, we screened 104 of 153 patients with stage III unresectable local advanced NSCLC and IV NSCLC who received PD-1/PD-L1 inhibitor therapy at our hospital and met the inclusion and exclusion criteria for analysis. All patients were collected for clinical information, including baseline blood indicator (NLR, PLR, LMR, SII, CRP, RDW, PCV and PCT) levels before PD-1/PD-L1 inhibitor therapy and blood indicator levels and imaging evaluation results every two cycles after PD-1/PD-L1 inhibitor therapy.
A word of caution in the functional monitoring of patients after rectal cancer surgery: a multicentre observational study.
Tech Coloproctol
January 2025
Colorectal Surgery Unit, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona UAB, Barcelona, Spain.
Background: Patients with rectal cancer often experience adverse effects on urinary, sexual, and digestive functions. Despite recognised impacts and available treatments, they are not fully integrated into follow-up protocols, thereby hindering appropriate interventions. The aim of the study was to discern the activities conducted in our routine clinical practice outside of clinical trials.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!