Authored by Zipher Medical Affairs, now part of Lumanity

New drugs must undergo rigorous assessments, including extensive company-sponsored clinical trials, when seeking approval. However, even with comprehensive datasets supporting regulatory application, gaps in information still exist and may adversely impact clinical and reimbursement decisions.

Common gaps include:

  • Patients excluded from clinical trials
  • Subgroups with limited representation in clinical trials
  • Details about the natural history of the disease
  • Endpoints not included in clinical trials
  • Differences in practice in the real-world setting
  • Comparison to competitors not included in the control arm(s)

Medical affairs fosters data generation to help fill these gaps, thereby increasing
the scientific body of understanding and expanding the available efficacy and safety data.