AACR, FDA and NCI Stress Importance of Biomarkers in Cancer Drug Development

The American Association for Cancer Research (AACR), Food and Drug Administration (FDA) and National Cancer Institute (NCI) joined forces in 2007 to form the Cancer Biomakers Collaboration. According to a recent report filed by the AACR in the journal Clinical Cancer Research, this collaboration seeks “to modernize the drug development process by incorporating new techniques that can predict the safety and effectiveness of new drugs faster, with more certainty, and at lower cost.”

The collaboration is particularly interested in improving the development process for cancer drugs related to biomarkers. In recent years, a number of important biomarkers have been identified that may help scientists engineer customized treatment options that dramatically improve survival for various types of cancer. However, the jump from biomarker research to viable drugs that exploit these biomarkers is considerable.

In an effort to overcome this research deficiency, the three organizations have developed a set of recommendations aimed at more effectively integrating biomarker research into traditional cancer drug development enterprises. These recommendations are based on the findings that:

  • Costs associated with drug development have increased tremendously

  • Success rates of clinical trials have diminished

  • Outdated trial designs reduce clinical testing results in early clinical stages

In an effort to curb these negative trends, the Cancer Biomarkers Collaboration has outlined recommendations in eight unique arenas. These arenas include:

  • Biospecimens: improving the quality and availability of biospecimens is a key initial goal that can dramatically improve biomaker research

  • Analytical performance: improved standardization of analytic performance for biomarker research

  • Standardization and harmonization: universal standards for biomarker research are sorely lacking

  • Bioinformatics: improved data standards to biomarker research

  • Collaboration and data sharing: cross-sharing of biomarker data

  • Regulatory issues: approval and clearance of biomarker research lacks standardization

  • Stakeholder education and communication: further steps need to be taken to inform stakeholders regarding compliance of new regulations and standards

  • Science policy: develop political policies that complement emerging biomarker research