The lag time in initiating clinical testing of new drugs in combination with radiation therapy, a significant barrier to progress?
Publication/Presentation Date
9-23-2014
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 was used to model how the lag time has changed over time.
RESULTS: The median lag time was 6 years. The initial phase I trial with RT was typically published 2 years after the first published positive phase III trial and 11 years before patent expiration. Using a best-fit linear model, lag time decreased from 10 years for phase I trials published in 1990 to 5 years in 2005 (slope significantly non-zero, P< 0.001).
CONCLUSIONS: Clinical drug development with RT commences late in the life cycle of anti-cancer agents. Taking into account the additional time required for late-phase clinical trials, the delay in initiating clinical testing of drug-RT combinations discourages drug companies from further pursuing RT-based development. Encouragingly, lag time appears to be decreasing. Further reduction in lag time may accelerate RT-based drug development, potentially improving patient outcomes.
Volume
111
Issue
7
First Page
1305
Last Page
1309
ISSN
1532-1827
Published In/Presented At
Blumenfeld, P., Pfeffer, R. M., Symon, Z., Den, R. B., Dicker, A. P., Raben, D., & Lawrence, Y. R. (2014). The lag time in initiating clinical testing of new drugs in combination with radiation therapy, a significant barrier to progress?. British journal of cancer, 111(7), 1305–1309. https://doi.org/10.1038/bjc.2014.448
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
25117813
Department(s)
Administration and Leadership
Document Type
Article