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, Inc. announced today that it has enrolled the 1,000th patient in a Phase I clinical trial through its US Oncology Research Network. Phase I clinical trials present special challenges, including increased safety concerns, higher variability of patient disease, more complex trial designs, and some first-in-human trials, making Phase I trials more difficult to operate in the community setting.
The US Oncology Research team has been helping investigators conduct new agent Phase I trials in community-based oncology since 2005. The US Oncology team running the trials–referred to as the Translational Oncology Program (TOP), is chaired by Daniel Von Hoff, M.D., chief scientific officer for US Oncology and physician-in-chief for the Translational Genomics Institute based out of Scottsdale, Ariz. TOP is a select group of physicians affiliated with the US Oncology Research Network that participate in Phase I research studies. This experience gives the physicians and their community-based practices a leadership role in the testing of new cancer therapies to provide novel therapeutic modalities for treatment and support to patients as early as possible. The TOP program also provides physicians and nurses experience with the agents early on in their development process.
Phase I trials are the beginning of clinical trial work–testing ideas and theories that could go on to save lives or improve the quality of life for patients. These trials often include the capability to examine pharmacokinetic aspects of the investigational agent as well as the pharmacogenetic variations among different patient populations to predict response. These elements of a Phase I trial help investigators understand how a drug is absorbed, distributed, metabolized and eliminated in the body so that toxicity can be closely monitored. This information is used to help bring the trial into Phase II, the next step in proving a new therapy's value in cancer care.
Investigators affiliated with the US Oncology Research Network are independent community-based oncologists who bring their past academic research experience to local communities across the country. The Network includes thought leaders in specific tumor types including Drs. Daniel Von Hoff, Allen Cohn, Carlos Becerra and Donald Richards who specialize in pancreatic, GI tract and other rare tumor types; Dr. Nicholas Vogelzang who specializes in bladder, kidney and other genitourinary tumors; Dr. Stephen Jones, who specializes in rare breast cancer tumor types; Dr. Lawrence Garbo who specializes in lung, GI, breast, gioblastoma and other rare tumors best treated in Phase I studies; Dr. David Smith who specializes in lung and hematology; Dr. Paul Conkling, who specializes in lung and GI; Dr. Joe Stephenson who specializes in various phase I work with various tumor types, and dozens of others.
Physicians involved in Phase I trials work in:
Each site has dedicated Phase I specially trained certified research nurses (CRN) and pharmacists (CRP). All nurses must be Registered Nurse (RN) trained. Each site features all necessary equipment to conduct specialized Phase I trials. The nationwide TOP committee conducts weekly meetings to discuss new findings, dosing, safety concerns and other areas of interest and concern to keep patients safe and to find leads for efficacy that can move the trial to Phase II.
In 2005, when US Oncology's TOP program began, 26 patients were enrolled in Phase I trials across the country. The following year, 124 patients were enrolled in Phase I trials and the number has continued to grow. 260 patients are expected to be enrolled in Phase I trials through the US Oncology Research Network in 2010.
US Oncology Research Fact Sheet:
US Oncology Research is physician-led and physician-driven with a successful history of clinical depth and expertise.