From the Editor's Desk

More than a decade ago, the Human Genome Project created great enthusiasm about the bright future of personalized medicine. What was the vision for the first decade of the 21^st century? The biotech industry will develop a wide range of biomarkers for different diseases. Based on the results of these biomarkers, new and targeted drugs will be developed and registered. A patient seeking medical care will be tested, and based on the results of different biomarkers the treating physician will be able to prescribe a personalized therapy. This was the theory. Unfortunately these expectations did not come true. Only a few biomarkers and drugs are currently available that follow the path described above. Even though research for these products started long before the millennium change, there is a tremendous financial investment for biomedical research and development including biomarker discovery. Biomarkers and biomarker research are an essential component of personalized medicine. The last decade saw a dramatic increase of newly discovered potential biomarkers published in scientific literature, but still the number of registered biomarkers increased only very little.

So what is going wrong?

Research is like high tech Swiss clockwork. The outcome depends on an optimal cooperation of all parts, and the weakest part defines the overall quality of the final product. A research program, such as on a new biomarker, is based on the results of multiple research projects. All the results need to be repeated, ideally by peers. Nobody questions that each project has to follow high-quality standardized procedures using high-quality equipment and consumables including well-defined biospecimens. However, there are some concerns about the quality of the biospecimens and data stored in biobanks and the effect this will have on scientific literature. ¹

As was shown recently there is a significant lack of information on the clinical biobanking of biospecimens (transport, storing, processing, QC etc.) in scientific articles. This lack of information hinders researchers from correctly interpreting and drawing accurate conclusions from these studies. ² For biomarker validation thousands if not tens of thousands of these well-defined biospecimens are needed. The quantitative issue can be solved by linking existing research biobanks and establishing meta-biobanks. Much more challenging is the qualitative issue. Initiatives like the Biospecimen Research Network by the National Cancer Institute's Office of Biorepositories and Biospecimen Research (OBBR) ³ or the European SPIDIA project ⁴ will develop evidence-based guidelines for clinical biobanking.

In the meantime there is an immediate call to action for everybody involved in biospecimen research. Biobankers not only should collect the information about clinical biobanking but also provide it to the researchers including those who may not require it for their research. Researchers should only use biospecimens from biobanks or meta-biobanks that can provide this information. Last but not least, the publishers and reviewers of scientific journals should not accept papers without this available information about biospecimens cited in the manuscript. Scientific journals are trend setters when it comes to defining requirements and inclusion criteria for publication. For example, some 15 years ago the first journals required statements on Institutional Review Board approval and informed consent. Nowadays, no scientific paper will be accepted without this information.

Biospecimen research, as all research, should go hand-in-hand with quality control. Medical progress can only be achieved by conducting high-quality research using well- defined biospecimens coming from high-standard biobanks and being published in state-of-the-art journals.