FDA differentiates between real-world data (RWD) vs real-world evidence (RWE)

  • In developing its RWE program, FDA believes it is helpful to distinguish between the sources of RWD and the evidence derived from that data.
  • Evaluating RWE in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate the evidence but also on the reliability and relevance of the underlying RWD.

Click here to learn more.

About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

For more information, please visit www.svmpharma.com and contact us at enquiry@svmpharma.com

ref: JAN2021VN001

Posted in Blogs.