Global Cooperation and Early Access-Clinical Outcomes Matter

Tibau Martorell A, Kesselheim AS - Lancet Oncology

  • Regulation and Clinical Evidence

Summary:

In this commentary on two analyses related to cancer drug approvals, the authors highlight that although using surrogate measures may reduce costs and expedite patient access to new treatments, these measures might not accurately predict overall survival benefits. Thus, rigorous post-approval testing and transparent data reporting are critical to ensure patients receive the most effective treatments.

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Recent Work from PORTAL

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence