Nature

Observational studies must be reformed before the next pandemic

Observational studies provide crucial information early during epidemics and pandemics, but they often suffer from methodological shortcomings, which can be resolved. Scientific research is a ...
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 ...
Nature

Observational studies in Alzheimer disease: bridging preclinical studies and clinical trials

Recent high-profile failures of Alzheimer disease treatments at the clinical trial stage have led to renewed efforts to identify and test novel interventions for Alzheimer disease and related ...
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 ...
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 ...
TCTMD

Current Examples of Observational Studies in Coronary Revascularization – When to do a Single Arm Study and How to Analyze Large Datasets

Dilemma 2: Do I Need Mechanical Circulatory Support? Case Presentation (LM with LVSD) Receive the the latest news, research, and presentations from major meetings right to your inbox. TCTMD ® is ...
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 ...
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 ...