Overall Survival as a Primary End Point in Multiple Myeloma Trials

Cliff ERS, Mohyuddin GR - Nature Reviews Clinical Oncology

  • Regulation and Clinical Evidence

Summary:

While progression-free survival may be a reasonable endpoint for first-line multiple myeloma trials given the disease’s long median survival, there are important scenarios—such as trials in penta-refractory patients with short life expectancies or those testing maintenance therapies that add toxicity—where overall survival and quality of life should remain the primary endpoints.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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
An icon of a bill representing government policy.

Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence