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The American Society of Clinical Oncology’s first-ever clinical trial is growing with the addition of its seventh and eighth pharmaceutical companies, Bayer and Merck, and 30 additional trial participants.
The American Society of Clinical Oncology (ASCO)’s first-ever clinical trial is growing with the addition of its seventh and eighth pharmaceutical companies, Bayer and Merck, and 30 additional trial participants.
ASCO kicked off its study, Targeted Agent and Profiling Utilization Registry (TAPUR), on March 14, 2016, in an effort to evaluate molecular targeted cancer drugs, as well as to discover additional uses of these drugs outside of their previously FDA-approved purposes. Since its inception, 18 participants have enrolled in the study, with another 31 individuals who are either giving consent to participate or who are completing the screening process.
The number of study participants isn’t the only statistic growing—TAPUR is currently underway in 37 clinical sites across the United States with additional locations in the works. About 100 clinical sites have already expressed interest in taking part in the study.
And with the additions of Bayer and Merck to the 6 pharmaceutical companies that previously agreed, the study researchers are able to test a host of medications and combination therapies. Bayer and Merck join Astellas, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, and Pfizer to provide 17 drugs in 15 different targeted therapy options for participants with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma.
“TAPUR addresses a critical priority for achieving the promise of precision medicine: identifying existing, effective treatments for cancers based on their genomic profiles,” Richard L. Schilsky, MD, FASCO, ASCO CEO, said in a statement. “Since only about 5% of adult patients participate in oncology clinical trials, creative approaches like TAPUR, whose study design is grounded in real-world clinical practice, are needed to gather information that will benefit future patients.”
The TAPUR study is in part run by employing the Syapse Precision Medicine Platform, which automates the eligibility assessment, drug ordering, study workflow (patient registration), and data collection sections of the study process. The Syapse-TAPUR application additionally provides the study with drug options based on genomic data and is directly responsible for acquiring these study drugs, which are dispensed from the Cardinal Health Specialty Pharmacy.
Additionally, ASCO and the Research Advocacy Network have teamed up to launch a sub-study that seeks to help the oncology community understand how tumor genomic testing is currently being used in the clinical world by oncologists as well as assist in educating providers and patients on genomic testing in general. This sub-study runs concurrently with TAPUR: 2 brief surveys are administered to physicians at time-points before and after TAPUR application.