There is immense untapped potential in the use of Real World Evidence (RWE) in medical product development. RWE can decrease costs while generating outcomes that matter to patients, but effective outcomes rely on proper curation and validation of data, and proper linking of datasets – as well as a knowledge of regulatory thinking on the use of RWE across the healthcare value chain.

To support continuous learning, DIA brings you complimentary digital downloads to spur thought, reflection, collaboration, and action. In your Resource Kit, you'll find links to intriguing articles from the DIA Global Forum and our peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS), exclusive podcast interviews, session recordings from DIA events, and more!

  • DARWIN EU: Evolution in Europe’s Use of Big Data
  • Proceedings: DIA China 2020: Real-World Data Studies as Complements to Randomized Clinical Trials
  • Encouraging Post-Market Evidence Generation for Transformative Therapies: Policies that Could Reduce the Data Collection Burden on Healthcare Providers
  • A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness
  • Enabling RWE Studies in India
  • RWD and RWE in Brazil: Perspective of the Brazilian Health Regulatory Agency (Anvisa)
  • Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative
Download Kit