https://biomedres.us/pdfs/BJSTR.MS.ID.009118.pdf Abstract: The CARES-310 clinical trial compared the safety and efficacy of camrelizumab, an anti-PD-1 antibody, combined with rivoceranib, a vascular endothelial growth factor receptor 2 (VEGFR2)-targeted tyrosine kinase inhibitor (TKI), versus the obsolete standard of care sorafenib as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC). In this independent analysis of the CARES-310 trial, […]
Archive for the ‘Regulatory Medical Writing’ Category
An Independent Review of Camrelizumab-Rivoceranib Combination Therapy for the Treatment of Hepatocellular Carcinoma and Rivoceranib for Gastric Cancer
Compounded Tirzepatide Therapy for Weight Loss: A Health Outcomes Researcher’s Perspective
Objective: A male health outcomes researcher, age 55 – 65, with BMI ≥ 27 kg/m2, but without type 2 diabetes, took compounded tirzepatide 7.5 mg/week therapy with a goal of losing 10% of body weight over approximately four weeks and restoring BMI ≤ 25 kg/m2. This study was also intended to offer a more sophisticated […]
Current research on drug used for obesity and weight loss
In the obesity landscape, glucagoon-like peptide-1 (GLP-1) agonists dominate the weight loss market. Amylin agonists work differently from GLP-1s but may be able to induce similar weight loss with fewer adverse events. My client wanted to understand the molecular differences between various amylin assets and their hypothetical impacts on the efficacy / adverse event profile. […]
Can Proteins be Modified to Fight Diseases and Cancer?
Proteolysis Targeting Chimera
Beautiful Reflection on Water House by a Lake
Pictures shot by Heather Cox Richardson while kayaking.
Clinical Evaluation Report (CER) Medical Writer
Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) in compliance with the European Union (EU) Medical Device Regulation (MDR). Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical […]
CMS Shared Savings Program
Background The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients […]
Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.
“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type […]