Quantifying Patient Investment in Novel Neurological Drug Development.

ABSTRACT: While the drug development literature provides numerous estimates of the financial costs to bring a new drug to market, the investment of patient-participants in the research process has not been described. Trial participants and their caregivers, like companies, invest time and undertake risk when they participate in prelicense trials. We determined the average number of patient-participants needed to develop a novel neurological drug. We created a cohort of 108 unapproved drugs first tested for efficacy between 2006 and 2011 and used ClinicalTrials.gov to capture enrollment in all subsequent prelicense trials of these drugs over a 9-year period. Our primary outcome was the average number of patients enrolled in prelicense neurological drug trials per drug that ultimately attained FDA app

SUBMITTER: MacPherson A 

PROVIDER: S-EPMC9606150 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature