Impact of Biomarkers on Clinical Trial Risk

Abstract

The last decade has witnessed the cost of drug development rise dramatically; concurrently, the number of new drug approvals has declined. Clinical trial failure rates have contributed significantly to this ‘innovation‘ crisis and are directly related to clinical trial risk. One strategy that is often touted to resolve this challenge depends on embracing a personalized medicine approach where treatment is tailored to a patient‘s unique genetic background. We highlight a new risk-based paradigm of clinical trial risk that evaluates the utility of biomarkers in drug development and their risk mitigation benefits. Furthermore, examples elucidating the current state of biomarker integration during clinical trials and the potential risks posed by doing so will be discussed.

KEYWORDS::

• biomarker
• clinical trial
• cost
• drug development
• FDA
• innovation
• risk

Financial & competing interests disclosure

G Reid is employed in the pharmaceutical industry with GlaxoSmithKline. TA Bin Yameen is also employed in the pharmaceutical industry with AstraZeneca. J Parker has worked in the pharmaceutical industry and is a medical advisor to the hedge fund Burlington Capital. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

G Reid is employed in the pharmaceutical industry with GlaxoSmithKline. TA Bin Yameen is also employed in the pharmaceutical industry with AstraZeneca. J Parker has worked in the pharmaceutical industry and is a medical advisor to the hedge fund Burlington Capital. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.