Assessment of the Extent of the Necessary Clinical Testing of New Biotechnological Products Based on the Analysis of Scientific Publications and Clinical Trials Reports
2015
To estimate patients risks and make clinical decisions, evidence based medicine (EBM) relies upon the results
of reproducible trials and experiments supported by accurate mathematical methods. Experimental and clinical
evidence is crucial, but laboratory testing and especially clinical trials are expensive and time-consuming.
On the other hand, a new medical product to be evaluated may be similar to one or many already tested.
Results of the studies hitherto performed with similar products may be a useful tool to determine the extent
of further pre-clinical and clinical testing. This paper suggests a workflow design aimed to support such
an approach including methods for information collection, assessment of research reliability, extraction of
structured information about trials and meta-analysis. Additionally, the paper contains a discussion of the
issues emering during development of an integrated software system that implements the proposed workflow.
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