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The U.S. Patent and Trademark Office awarded a patent to the Moffitt Cancer Center at University of South Florida in Tampa on its system for matching patients to clinical trials based on molecular profiles of the patients and drugs. Patent number 8,095,389 was granted last month to inventors William Dalton, president of the Moffitt Cancer Center, and Timothy Yeatman, one of its division directors.
The patent covers a system that stores molecular profiles of potential clinical trial participants in a database, derived from tissue or tumor samples. The system then nominates candidates for trials based on the molecular properties of the drug being tested. The system’s process for selecting trial participants also takes into account other key characteristics of the patient: disease or diagnosis, symptoms, demographic factors, and family history.
The system aims to address a problem encountered in the design of clinical trials, namely enrolling patients with the desired characteristics to enable a thorough test of the drug candidate’s efficacy and safety. Although patients may meet the trial protocol’s initial criteria, such as disease or basic demographic factors, the drug may not be right for some patients because their molecular profiles are not a good match for the chemical and molecular properties of the drug. Finding these mismatches can reduce the potential for adverse effects or ineffective therapies.
The patented system aims at reducing the time needed to identify and enroll participants for clinical trials. The patent notes that the time needed for trials covers about half of the 15-year period needed to get a new drug on the market. With the promise of personalized medicine, the design of clinical trials is likely to become even more complex, putting even more demands on finding suitable participants.
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- Field Test of New Clinical Trial Method Underway
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