Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Importance: The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized.
Objective: To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials.
Design, Setting, And Participants: From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis.
Exposures: Request for IPD from 91 clinical oncology trials indicated as eligible for the request.
Main Outcomes And Measures: The utility and completeness of the IPD and supporting documents provided.
Results: The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted.
Conclusions And Relevance: In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10557028 | PMC |
| http://dx.doi.org/10.1001/jamaoncol.2023.3996 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The role and mechanism of abnormal lipid metabolism in colorectal cancer.
Sci Prog
September 2025
Shenzhen University Sixth Affiliated Hospital, Shenzhen Nanshan People's Hospital, Shenzhen, China.
Colorectal cancer ranks among the most prevalent and lethal malignant tumors globally. Historically, the incidence of colorectal cancer in China has been lower than that in developed European and American countries; however, recent trends indicate a rising incidence due to changes in dietary patterns and lifestyle. Lipids serve critical roles in human physiology, such as energy provision, cell membrane formation, signaling molecule function, and hormone synthesis.
View Article and Find Full Text PDFComparative Safety of JAK Inhibitors vs TNF Antagonists in Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis.
JAMA Netw Open
September 2025
Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla.
Importance: Janus kinase (JAK) inhibitors are highly effective medications for several immune-mediated inflammatory diseases (IMIDs). However, safety concerns have led to regulatory restrictions.
Objective: To compare the risk of adverse events with JAK inhibitors vs tumor necrosis factor (TNF) antagonists in patients with IMIDs in head-to-head comparative effectiveness studies.
Evaluation of ambulatory use of daratumumab hyaluronidase injection.
J Oncol Pharm Pract
September 2025
Hematology/Oncology, Scripps Clinic, La Jolla, USA.
IntroductionDaratumumab is a therapeutic cornerstone of the management of multiple myeloma, exerting its anti-myeloma activity through targeting of the cell surface glycoprotein CD38 on plasma cells. While originally given intravenously, the subcutaneous formulation, daratumumab hyaluronidase injection (Dara SC), has been associated with non-inferior efficacy and lower infusion-related reaction rates (IRRs) in the treatment of multiple myeloma and light chain amyloidosis. A noted benefit of Dara SC is a short administration time; however, the optimal observation time post injection to ensure patient safety is unclear from the drug labeling.
View Article and Find Full Text PDFBackground: People with dementia who have a fall can experience both physical and psychological effects, often leading to diminished independence. Falls impose economic costs on the healthcare system. Despite elevated fall risks in dementia populations, evidence supporting effective home-based interventions remains limited.
View Article and Find Full Text PDFA review of the effect of SGLT2 inhibitors on clinical and glycemic outcomes in hospitalized patients: data from studies that included patients with diabetes.
Hormones (Athens)
September 2025
Division of Endocrinology, Baltimore VA Medical Center, Baltimore, MD, USA.
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are a fairly new class of agents for diabetes that have demonstrated significant benefits in glycemic control and cardiovascular outcomes with outpatient use. The aim of this review is to provide an overview of the effect of SGLT2i use on glycemic control and clinical outcomes in the hospital setting.An electronic search of PubMed was conducted to analyze publications that assessed the inpatient use of SGLT2i and included patients with diabetes.
View Article and Find Full Text PDF