RWE 101 – Purpose of Real World Evidence
The purpose of real-world evidence (RWE) is to provide insights into the safety, effectiveness, and value of medical products and interventions outside of the controlled environment of clinical trials. RWE is generated by collecting data from various sources, such as electronic health records, claims data, patient-generated data, and social media.
RWE is increasingly being used by healthcare stakeholders, such as regulatory agencies, payers, providers, and patients, to make informed decisions about healthcare products and interventions. For example, regulatory agencies may use RWE to supplement the evidence from clinical trials and to evaluate the safety and effectiveness of medical products in real-world settings. Payers may use RWE to make coverage and reimbursement decisions based on the value of medical products and interventions. Providers may use RWE to inform clinical decision-making and improve patient outcomes. Patients may use RWE to make more informed decisions about their own healthcare.
Overall, RWE can provide a more complete picture of the benefits and risks of medical products and interventions in real-world settings, which can lead to better healthcare decision-making and ultimately improve patient outcomes.
Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context
stuart.mccully2023-08-09T15:27:28+00:00August 9, 2023|2023, RWE 101|
RWE 101 - ICH GCP (R3) - Real World Evidence Context Revision 2 of ICH GCP caused confusion to those of us who work with non-interventional studies. The glossary [...]
Real World Evidence (RWE) 101 – Non-Interventional Studies vs Market Health Research
stuart.mccully2023-08-09T15:02:58+00:00August 9, 2023|2023, RWE 101|
RWE 101 - Non-Interventional Studies vs Market Health Research Key differences between a non-interventional study (NIS) and market health research include:1. Research Objective: NIS are conducted to examine real-world [...]
Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections
stuart.mccully2023-08-09T14:51:12+00:00August 9, 2023|2023, RWE 101|
RWE 101 - Real World Evidence (RWE) 101 - Audits vs Inspections In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, [...]
Real World Evidence (RWE) 101 – A Career of Many Pathways
stuart.mccully2023-08-07T22:28:44+00:00August 7, 2023|2023, RWE 101|
RWE 101 - A Career of Many Pathways Real-world evidence (RWE) refers to the information on health care that is derived from analysis of real-world data (RWD). RWE [...]
Real World Evidence (RWE) 101 – Evolution of Regulatory Affairs
stuart.mccully2023-08-07T22:02:40+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Evolution of Regulatory Affairs Real-world evidence (RWE) and real-world data (RWD) are increasingly influencing regulatory affairs in the biopharmaceutical and healthcare industry. This change has been [...]
Real World Evidence (RWE) 101 – Project Managers
stuart.mccully2023-08-07T21:50:20+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Project Managers Real-World Evidence (RWE) observational studies and clinical trials are both key elements of medical research, but they involve very different methodologies, aims, and requirements. [...]