National Academies of Sciences%2c Engineering%2c and Medicine

Observational Studies in a Learning Health System: Workshop Summary

• Accounting for bias is a major challenge confronting the use of observational data to gain important insights into real-world treatment effects. • No single study design will satisfy all information ...
Medical Xpress

Observational analyses can complement randomized clinical trial findings for the study of HPV vaccine effectiveness

Led by researchers at NDORMS as part of the Data Analysis and Real World Interrogation Network (DARWIN EU) initiative, a new European study has shown that carefully designed observational studies can ...
ascopubs.org

Observational study examining the feasibility of generating real-world evidence (RWE) for new drug applications from the clinical trials database (DB; RELIASE study).

Protocol amendment for ENSEMBLE study: A multicenter, randomized, phase III trial to test the superiority of consolidation irinotecan, capecitabine and oxaliplatin vs capecitabine and oxaliplatin ...
RMD Open

Site-specific articular responses to b/tsDMARDs in rheumatoid arthritis: a longitudinal observational study from the Swiss Clinical Quality Management Registry

This joint-specific response pattern was consistent across all advanced treatment modalities, including abatacept, interleukin-6 receptor inhibitors, Janus kinase inhibitors, rituximab and TNFi.
ascopubs.org

A multicenter, observational, phase 4 study (STELLAR) to evaluate the safety and tolerability of lenvatinib (LEN) in patients with advanced or unresectable hepatocellular ...

Emerging treatments for advanced cholangiocarcinoma: Addressing the knowledge gap. Background: HCC is a leading cause of cancer-related deaths worldwide. LEN is now a first-line treatment option for ...
RAPS

ICH adopts M14 guideline on observational studies

The International Council on Harmonisation (ICH) announced on Friday the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies ...
Healthline

Types of Medical Studies: Your Guide

Medical research shapes healthcare every day, but not all studies are created equal. Knowing the differences can help you feel more confident reading health information online and understanding what ...