Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved.

ABSTRACT:

Background

Phase I oncology trials are often regarded as a therapeutic option for patients. However, such claims have relied on surrogate measures of benefit, such as objective response.

Methods

Using a systematic search of publications, we assessed the therapeutic value of phase I cancer trial participation by determining the probability that patients will receive active doses of treatments that eventually receive FDA approval or a National Comprehensive Cancer Network (NCCN) guideline recommendation for their indication. ClinicalTrials.gov, PubMed, American Society of Clinical Oncology reports, NCCN guidelines, and Drugs@FDA were searched between May 1, 2018, and July 31, 2018. All statistical tests were 2-sided.

Results

A total of 1000 phase I oncology trials initi

SUBMITTER: Zhang SX 

PROVIDER: S-EPMC7492767 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature