Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

Maryam Mooghali; Ayman Mohammad; Joshua D Wallach; Aaron P Mitchell; Joseph S Ross; Reshma Ramachandran

doi:10.1001/jamanetworkopen.2024.9233

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

JAMA Netw Open. 2024 May 1;7(5):e249233. doi: 10.1001/jamanetworkopen.2024.9233.

Authors

Maryam Mooghali^{1

2}, Ayman Mohammad³, Joshua D Wallach^{2

4}, Aaron P Mitchell⁵, Joseph S Ross^{1

2

6

7}, Reshma Ramachandran^{1

2}

Affiliations

¹ Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
² Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut.
³ Icahn School of Medicine at Mount Sinai, New York, New York.
⁴ Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.
⁵ Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
⁶ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁷ Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.

No abstract available

Plain language summary

This cross-sectional study evaluates the use of the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) program in confirming the effectiveness of cancer drugs.

MeSH terms

Antineoplastic Agents / therapeutic use
Drug Approval*
Humans
Medical Oncology
Neoplasms / drug therapy
Product Surveillance, Postmarketing* / methods
Product Surveillance, Postmarketing* / standards
Product Surveillance, Postmarketing* / statistics & numerical data
United States
United States Food and Drug Administration*

Substances

Antineoplastic Agents

Grants and funding

P30 CA008748/CA/NCI NIH HHS/United States