Biomarkers in clinical trials

Report tackles preconception that biomarker tests are unreliable, with biomarker validation being expensive and adding a further level of complexity to the clinical development phase

Escalating costs and lengthy clinical trials are major concerns for researchers attempting to boost productivity and efficiency in the field of drug discovery.

Biomarkers are emerging as the solution to these problems with their ability to reduce drug development costs and time.

"The clinical trials phase currently accounts for over 60% of drug discovery and development cost, and it may take up to US$1.7 billion to get a drug to market," explains research analyst Phil Webster from Frost and Sullivan.

"Using biomarkers to indicate drug efficacy and toxicity or to stratify patient populations has the potential to significantly reduce clinical trial costs and duration".

The global biomarkers market is expected to grow at a compound annual growth rate (CAGR) of 28.5% from $0.63 billion in 2004 to $2.90 billion in 2008.

Despite the early stages of market development, leading drug companies are already responding by investing in biomarker discovery programmes.

Failure of potential drugs to clear clinical trials is another factor driving research in biomarkers.

Approximately 90% of compounds fail during clinical development.

Over 60% of those failures are due to absorption, distribution, metabolism, excretion (ADME) problems, as well as toxicology.

Currently, there is a preconception that biomarker tests are unreliable, with biomarker validation being regarded as expensive and adding a further level of complexity to the clinical development phase.

However, the advent of biomarker pattern profiling in the post-genomic era rather than reliance on a single target promises to improve results.

"Since the cost of failure is high, and this increases at later stages of the clinical trial phase, biomarkers can be used to identify potential drug failures at an early stage and save costs in the long term," observes Webster.

The sizeable initial investment required in terms of time and money is a major stumbling block to the increased uptake of biomarkers.

An appropriate strategy is needed to maximise benefit and ultimately reduce the financial cost involved in clinical development.

"Although biomarkers initially increase the cost of clinical development, as a larger biomarker portfolio is developed and other drug discovery technologies are integrated, the cost and duration of clinical development are expected to drop to acceptable limits," says Webster.

Regulatory agencies are currently unwilling to compromise drug safety and efficacy and are, therefore, being cautious about implementing new regulations regarding biomarkers.

Once adequate biomarker data has been assembled, regulatory authorities are likely to be more forthcoming in acknowledging the biomarkers' capabilities and promote their registration as validated surrogate endpoints.

Given the increased prevalence of terminal diseases among the ageing baby boomer generation, the US Food and Drug Administration (FDA) has recognised the need for an accelerated drug pipeline and is proving to be more supportive of biomarkers and their capabilities in making drug approval quicker and cheaper.

For sustained growth in the biomarkers market, researchers need to integrate biomarker identification with the drug development and pre-clinical testing process.

They can also develop biomarkers for use in long-term diagnostics, which may have a separate market once the drug is commercialised.

Back to top