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… Factual presentations of results from studies, including clinical studies (i.e., no characterizations or conclusions … Disease Description Section 3 Clinical Evidence - studies supporting unapproved product; may be text and evidence … uses; text and evidence tables Clinical Evidence - studies supporting unapproved use; may be text and evidence tables …
Pharmacoepidemiology and Risk Management Regulatory Real-World Evidence Research Let us help you ensure the safety of your patients by examining and understanding disease indicators and using real-world evidence to support your development and …
… Our client had a product in multiple phase 2 and 3 clinical trials for the treatment of numerous rare disease …
AMCP 2024 Share on: Monday, April 15 - Thursday, April 18, 2024 Conference website Research coauthored by RTI Health Solutions will be presented at AMCP 2024. If you are attending, please stop by our posters and see our research on Avelumab therapy and …
… at the 2023 ESMO Breast Cancer Annual Congress. Real-world clinical outcomes associated with first-line palbociclib and … G, Jimenez M, Davis KL, Broughton EI. Poster Real-world clinical outcomes among patients (pts) with …
Webinar: Best Practices for Adopting AMCP Format Version 5.0 Share on: Tuesday, August 6, 2024, 12 - 12:45pm Register now Event: August 6, 2024 | 12:00 EDT The Academy of Managed Care Pharmacy (AMCP) dossier Format for Formulary Submissions (AMCP …
In-Person Course: Regulatory-Grade Causal Inference in Health Research Share on: Wednesday, March 12, 2025, 3pm - Friday, March 14, 2025, 1pm Learn to Use Target Trial Emulation for Regulatory Real-World Evidence Generation Presented by RTI Health …
… in Observational Studies: Design Strategies Randomized clinical trials (RCTs) are the gold standard to quantify the … and safety of medical interventions. Unfortunately, many clinical questions have not been answered yet by an RCT, and …
… evaluate evidence from patient-reported outcomes (PROs) in clinical trials. Study sponsors pursuing PRO drug labeling … face when including PRO-related endpoints in cancer clinical research? And how can these challenges be overcome? …
… editor. She began her career as a health reporter for The News & Observer in Raleigh, NC, and other publications, where …