Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.

ABSTRACT:

Importance

Clinical trial evidence used to support drug approval is typically the only information on benefits and harms that patients and clinicians can use for decision-making when novel cancer therapies become available. Various evaluations have raised concern about the uncertainty surrounding these data, and a systematic investigation of the available information on treatment outcomes for cancer drugs approved by the US Food and Drug Administration (FDA) is warranted.

Objective

To describe the clinical trial data available on treatment outcomes at the time of FDA approval of all novel cancer drugs approved for the first time between 2000 and 2016.

Design, setting, and participants

This comparative effectiveness study analyzed randomized clinical trials and single-

SUBMITTER: Ladanie A 

PROVIDER: S-EPMC7656288 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature