Real-World Data / Real-Word Evidence Insights

31. How Can I Use Real-World Data In Clinical Trials? 3/29/2022

    Real-world data (RWD) and real-world evidence (RWE) can be relevant and essential to bringing innovation to patients and gaining regulatory approval. This article describes the sources of real-world data, how to use real-world data to enhance a development program, and how RWD and RWE advance regulatory decision-making.

32. How Our Foundation Is Advancing The Use Of Real-World Evidence In Cancer Research 2/24/2022

    The pandemic has sped up the widespread use of real-world evidence (RWE). It is being used to inform the development of new drugs and medical products, and it helps inform about patients’ treatment journeys. Challenges remain in assuring the quality of the real-world data that is collected and the opportunity for long-term follow-up for participating patients, but those are challenges that can be overcome with the right tools and support.

33. FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products 1/19/2022

    The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.