Optimizing Oncology Drug Development: Systematic Review of 22 Years of Myeloma Randomized Controlled Trials

Mainou M, Alsadhan M, Tsapa K, Visram A, Mian H, Popat R, Mai EK, Chakraborty R, Al Hadidi S, Mohan M, Szabo A, Van Oekelen O, Cliff ERS, Mohyuddin GR - Journal of the National Cancer Institute

  • Regulation and Clinical Evidence

Summary:

Across 123 randomized myeloma trials, studies were far less likely to succeed when overall survival was the primary endpoint and when enrolled populations were older. Endpoint selection and trial population design strongly influence apparent trial success and should be explicitly weighed by sponsors and regulators.

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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
Talk bubble graphics representing commentary and opinion.

The Impact of Semantics in Medicines Regulation

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

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence