Assessment of the Extent of the Necessary Clinical Testing of New Biotechnological Products Based on the Analysis of Scientific Publications and Clinical Trials Reports

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.