The lag time in initiating clinical testing of new drugs in combination with radiation therapy, a significant barrier to progress?

ABSTRACT:

Background

The clinical development of new drugs with radiation appears to be limited. We hypothesised that phase I clinical trials with radiation therapy (RT) are initiated too late into a new drug's lifetime, impeding the ability to complete RT-drug development programmes before patent expiration.

Methods

We identified novel drug-radiation phase I combination trials performed between 1980 and 2012 within the PubMed and ClinicalTrials.gov databases. Data gathered for each drug included: date the initial phase I trial with/without RT was opened/published, date of the published positive phase III trials, and patent expiration dates. Lag time was defined as the interval between opening of the phase I trial without RT and the opening of the phase I with RT. Linear regression wa

SUBMITTER: Blumenfeld P 

PROVIDER: S-EPMC4183859 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature