Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis.

ABSTRACT:

Purpose

To date there has not been an extensive analysis of the outcomes of biomarker use in oncology.

Methods

Data were pooled across four indications in oncology drawing upon trial outcomes from www.clinicaltrials.gov: breast cancer, non-small cell lung cancer (NSCLC), melanoma and colorectal cancer from 1998 to 2017. We compared the likelihood drugs would progress through the stages of clinical trial testing to approval based on biomarker status. This was done with multi-state Markov models, tools that describe the stochastic process in which subjects move among a finite number of states.

Results

Over 10000 trials were screened, which yielded 745 drugs. The inclusion of biomarker status as a covariate significantly improved the fit of the Markov model in describing

SUBMITTER: Parker JL 

PROVIDER: S-EPMC7957156 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature