An international study proposes new guidelines for the clinical field

A group of Fondazione Bruno Kessler scientists has participated as the only Italian team to the research, coordinated by the Food and Drug Administration and published in Nature Biotechnology.
 
(v.l.) Research on human genome is strongly aimed to predict the development of possible diseases and to assess in advance the efficiency, even at an individual level, of new drugs. Forefront biotechnology, such as the “microarray” technique, has made the simultaneous analysis of thousands of samples possible, but so far there has been no experiment carried out on a grand scale to determine the reliability of predictions arising from it, so fundamental to individuals and the community. Researchers from the MAQC-II project have addressed this issue involving 36 international research groups coordinated by the Food and Drug Administration (FDA), the U.S. drug agency.
The only Italian team participating, being that made up by Cesare Furlanello (responsible), Giuseppe Jurman, Samantha Riccadonna and Roberto Visintainer of the MPBA Unit that, at the Fondazione Bruno Kessler Information Technology Centre in Trento, deals precisely with predictive models for biomedicine and the environment.
The findings published in the latest issue of the international scientific reference journal "Nature Biotechnology" are proposed as a basis of the guidelines for drug research and the clinical applications.
"During the experiment," explained Caesar Furlanello "independent academic and industrial research teams confronted each other on the same genetic data of toxicological and clinical interest. Thirteen problems were analyzed and a total of over 30,000 models were developed, relative to different types of tumours. Researchers were asked to declare in advance all calculation techniques for the finding of candidate genes, while only the FDA knew about the clinical value of the validation data. The final comparison between the results produced by the different predictive models developed, enabled to identify the main causes of variability, sometimes linked to analytical methods, and make very strict references that FDA will need in the acceptance stages of new drugs or innovative procedures”.
"As the FBK team" continues Furlanello "we are very satisfied with the results obtained within the MAQC-II: one of our models has been selected as the best for one of the problems proposed, and in general our models were among the most stable. Participation was very challenging, with months of calculation and a little scientific risk, even though this was not a competition but a research dedicated at building shared rules of analysis, however, we now have a high-performance and reproducibility bioinformatics system that we are already enhancing with other research centres. One of the most important games of genomic medicine depends now on scientific reproducibility".
Besides the work on Nature Biotechnology, focuses on the issues have been published simultaneously in The Pharmacogenomics Journal, the scientific journal of the Nature group, with contributions from FBK researchers. A study, the primary author of which being the young researcher Marco Chierici, showed a serious problem existing in the calculation of genetic biomarkers and suggested a correction.

For further information:
- The MAQC-II study on Nature Biotechnology: http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.1665.html

- The MPBA unit of the Fondazione Bruno Kessler: http://mpba.fbk.eu

- Number of special studies on the Pharmacogenomics Journal project: http://www.nature.com/tpj/journal/v10/n4/index.html