The benefit using an integrated electronic trial platform for a neoadjuvant therapy trial (HEDON) in primary breast cancer – results of an evaluation study.

Abstract

Abstract Abstract #3114 Background: At present, academic medical centers conducting investigator initiated trials (IIT) have the choice of relying on paper or going electronic regarding electronic data capture and data management solutions. Many of the electronic systems have originally been developed for requirements of the pharmaceutical industry and all of the currently available systems would thus be isolated in the existing IT setting of the medical centers.
 We here suggest an approach to integrate a data management system into existing hospital information systems (HIS) and to provide the end users (e.g. physicians, investigators, study nurses) with consolidated user interfaces and integrated systems.
 Methods: In 2005, a collaboration between the Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich and Siemens Medical Solutions was initiated as a pilot project.
 An integrated platform for clinical trials was developed and implemented to support the HEDON trial (Herceptin-Docetaxel-Neoadjuvant), an investigator initiated clinical phase II trial concerning primary systemic therapy of breast cancer. The HEDON trial started in February 2006 and will have recruited all of a total of 90 planned patients in the end of this year. In addition, a translational research trial (TransHEDON) evaluating therapy response markers is an essential component of the clinical trial.
 Using the integrated platform, clinical data as well as laboratory data are automatically populated from the HIS into the electronical study CRFs, after data confirmation by investigators or study nurses (depending on their defined role) using the validation buffer of the system. The existing PACS and HIS are made accessible from the platform which has special capabilities to greatly improve user interactions with all relevant systems. To quantify the benefit of such an integrated system, an integrated evaluation project was set up including the quantification time savings for all involved personnel. For a pre-defined time period, data capture and data management processes are performed paper based and electronically. This allows thorough and critical analysis of all involved processes
 Resukts; Errors that occur specially due to manually entering laboratory data can be dramatically minimized using such an electronical data capture system. Another important benefit is time savings. The data will be presented.
 Conclusion:This single-sign-on electronic platform for clinical trials has been validated in its whole and fulfils the regulatory requirements as specified by GCP or 21 CFR part 11 compliance for trials of the FDA. We consider this integrated system to be very helpful for implementation of clinical trials into a routine hospital setting. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 3114.