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

Observational Studies in a Learning Health System: Workshop Summary

• Greater rigor is needed in the use of observational methods; even the best methods used incorrectly will yield bad results. (Goodman) • No one method is infallible, multiple methods are needed to ...
Labroots

New method for standardized, high-throughput PBMC isolation from blood samples for observational and clinical studies

Standardization and reproducibility are prerequisites for peripheral blood mononuclear cell (PBMC) generation from donor or patient samples in PBMC-based studies. Whether you are analyzing ...
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 ...
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 ...