Current oncology reports
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Current oncology reports · Dec 2012
Multicenter StudyThe automatic clinical trial: leveraging the electronic medical record in multisite cancer clinical trials.
Submission of data into clinical trial electronic data capture (EDC) systems currently requires redundant entry of data that already exist in the electronic medical record (EMR). Being able to automatically transfer data from the EMR to the EDC system would save many hours of arduous effort, especially for multisite data-intensive oncology trials. Standardization of the way in which data are stored in and retrieved from the EMR and techniques for mining data from the unstructured narrative will provide opportunities for transferring data from the EMR to the EDC system. As different EMRs proliferate, other technology in the form of data mining or middle-tier applications is certain to provide assistance in this effort.
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Trials with tamoxifen have clearly shown that the risk of developing oestrogen receptor-positive breast cancer can be reduced by at least 50 % with prophylactic agents. The current challenge is to find new agents which achieve this or better efficacy, but with fewer side effects. ⋯ The IBIS-II trial is currently investigating anastrozole in healthy postmenopausal women. New agents are needed for receptor negative breast cancer and premenopausal women, and several possibilities are currently under investigation.