| Data-sharing is changing the face of clinical trials. Dr Robert Modre-Osprian and Dr Günter Schreier at Austrian Research Centers GmbH analyse image management solutions for multi-centric medical research networks
Multi-centric and international clinical research in oncology or in the realm of rare diseases follows complex designs with an increasing number of participating institutions and investigational sites. International large-scale studies within medical research communities facilitate collaboration of physicians and specialists of associated research fields, reaching a critical mass for risk-based treatment stratifications and the development of new therapeutic concepts.
Any IT software solutions in support of such issues must deal with this complexity, which is further amplified by large-scale research in terms of the number of investigational sites, study physicians, countries and often long durations of such trials. To enable cooperation within medical research communities, it is a prerequisite to establish an electronic network to assure the data flow within the group of partners, and to manage all the tasks and needs of the individuals. The internet has been introduced into the management of some aspects of clinical trials, such as data entry on electronic case report forms (eCRFs), electronic data retrieval, remote randomisation and the distribution of information on trial progress.
From a scientific point of view and also for regulatory reasons, the consistency and accuracy of data from clinical trials should be known, irrespective of whether these data are generated by quantitative image analyses, blinded readings or visual interpretations. A high-quality IT system design of a web-based medical research network for multiinstitutional biomedical and clinical research projects facilitates the confidentiality, security and integrity of electronic data.
THE IMPORTANCE OF IMAGING
Medical imaging is gaining an important role in clinical trials and the perception of imaging technology is changing; imaging is increasingly viewed as one of the most powerful cost-saving strategies to measure and monitor the effects of the drug or device under evaluation. FDA guidance document ‘Guidance for Industry, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics’ is evidence of a rigorous approach to documentation in oncology trials. |
