Clinical Trial Failure May Be Counteracted by Biomarkers in the Future

Biomarkers could someday decrease the amount of failed clinical trials, if fully supported by the medical community, according to new market research.

The new report, published by healthcare market research company GBI Research (New York, NY, USA), noted that biomarkers can be utilized in all phases of drug discovery to determine the safety and effectiveness of candidate drugs. They are able to identify a number of lead candidates and drug targets, while predicting which drugs will not work, saving drug discovery costs and research time in the early stages of development.

With surging drug attrition rates, the proportion of drugs gaining regulatory approval has been reduced to only 8%, and most failures during the drug discovery process happen in the late clinical trial stages, leading to a considerable loss of money, time, and effort and patients are left untreated. The year 2007 saw the fewest drug approvals since 1983, alarming the pharmaceuticals sector and creating a demand for drug discovery techniques that can more effectively predict failures.

Biomarkers have several benefits over traditional drug discovery approaches--for example, they are highly sensitive and selective in their approach, and their application in drug discovery makes the process robust and time-efficient.

However, in spite of benefits of biomarkers over conventional methods, most pharmaceutical companies, academic institutions, and clinical practitioners do not use them extensively in drug discovery due to a lack of awareness among the academic community. Although essential research data are available, there is a scarcity of intelligent and novel technologic developments such as technology systems and biomarker assays, and this is restraining growth of the global biomarkers market.

Funding problems also pose a challenge for the necessary R&D of biomarkers. The development process of biomarkers requires strong technical expertise and the combination of genomic, proteomic, and transcriptomics-based technologies, which are very expensive and require huge funding. However, many funding organizations require strong clinical data and validation to provide funds for research and testing phases, and the initial gathering of data itself requires funding, thereby forming a vicious circle. The biomarker discovery and confirmation procedure is also long and burdensome, with only 1% of all biomarkers found reaching the validation stage.

Until the profile of biomarkers is adequately increased, and enough money is invested, the pharmaceutical industry will not see the benefits of biomarkers in action, in spite of the billion-dollar clinical trial industry they could potentially transform.

GBI Research is a provider of business intelligence reports, providing actionable data and forecasts based on the insights of industry leaders.

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