Patient Enrollment per Month (Accrual) in Clinical Trials Leading to the FDA Approval of New Cancer Drugs.

ABSTRACT:

Background

Insufficient patient enrollment per month (=accrual) is the leading cause of cancer trial termination.

Objective

To identify and quantify factors associated with patient accrual in trials leading to the US Food and Drug Administration (FDA) approval of new cancer drugs.

Data

All anti-cancer drugs with FDA approval were identified in the Drugs@FDA database (2000-2022). Data on drug indication's background-, treatment-, disease-, and trial-related factors were collected from FDA labels, clinicaltrials.gov, and the Global Burden of Disease study. The association between patient accrual and collected variables was assessed in Poisson regression models reporting adjusted rate ratios (aRR).

Results

We identified 170 drugs with approval in 455 cancer indica

SUBMITTER: Michaeli DT 

PROVIDER: S-EPMC11392992 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature