Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107578 | PMC |
http://dx.doi.org/10.1038/s43856-023-00281-1 | DOI Listing |
Rheumatol Int
January 2025
Department of Internal Medicine, General Hospital Oberndorf, Teaching Hospital of the Paracelsus Medical University, Salzburg, Austria.
Rheumatoid arthritis (RA) is a chronic autoimmune disease marked by systemic inflammation. While RA primarily affects the joints, its systemic effects may lead to an increased cerebro- and cardiovascular risk. Atherosclerosis of the carotid arteries is a significant risk factor for cerebrovascular events and serves as a surrogate marker for cardiovascular risk.
View Article and Find Full Text PDFArch Gynecol Obstet
January 2025
Post-Graduate Program in Health Sciences (PPGCS) Universidade do Sul de Santa Catarina, Av. Pedra Branca, 25, Palhoça, SC, Brazil.
Purpose: This updated systematic review and meta-analysis aims to evaluate the impact of a birthing ball (BB) exercises on low-risk parturients during labor, offering a more comprehensive understanding through a larger sample size, robust analysis, and focus on relevant endpoints that were underexplored in previous studies due to limited data.
Methods: We searched PubMed, Embase, Scopus, and Cochrane Central for randomized controlled trials (RCTs) comparing BB (also named Swiss ball) exercises with no intervention or standard care in parturients undergoing low-risk labor. Risk ratios (RR) and mean differences (MD) were calculated using a random-effects model.
Cancer Commun (Lond)
January 2025
Department of Medical Oncology, Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang, P. R. China.
Background: The standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive recurrent/metastatic breast cancer currently includes pertuzumab plus trastuzumab and docetaxel. This study aimed to evaluate the effectiveness of KN026, an anti-HER2 bispecific antibody, plus docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer.
Methods: This open-label, single-arm, phase II study enrolled patients with HER2-positive recurrent/metastatic breast cancer in 19 centers across China from December 30, 2019 to May 27, 2021.
Aliment Pharmacol Ther
January 2025
Division of Gastroenterology and Hepatology, Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.
Background: Novel colorectal cancer endoscopic surveillance techniques for inflammatory bowel disease (IBD) have recently been developed.
Aims: Compare the efficacy of currently available techniques for dysplasia detection in colonic IBD.
Methods: We conducted a systematic literature search from inception to March 2024 for randomized controlled trials (RCTs) or prospective cohort studies enrolling adults with IBD and having surveillance colonoscopy for dysplasia screening.
Int J Cancer
January 2025
Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China.
The effectiveness and safety of combining anlotinib with gemcitabine and cisplatin in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) have not been definitively established. This research seeks to investigate the potential benefits and risks of utilizing this combination therapy in the first-line management of R/M NPC. The research involved 22 individuals diagnosed with R/M NPC and who had not undergone any previous treatment.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!