Oncology CRO Publishes Free "Patient Safety in Oncology Clinical Trials" Abstract for Chief Medical Officers
Patient safety has always been the industry's focus during clinical trials. However, a recent spate of well-publicized patient safety issues has increased public scrutiny and the industry's desire to improve study quality, resulting in larger, longer, more expensive trials. In "Patient Safety in Oncology Clinical Trials," Dr. James Gourzis discusses patient safety as it pertains specifically to oncology clinical trials. The abstract is available for download on the Medelis Oncology CRO website.
Phoenix, AZ (PRWEB) March 25, 2008 -- Medelis, Inc., a single-source provider for oncology CRO and oncology drug development services, today published "Patient Safety in Oncology Clinical Trials," the first abstract in "Peer Perspectives in Oncology," a new Q&A series that brings together respected researchers to discuss issues that face Chief Medical Officers today: rising costs, optimum patient accrual, targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines.
Oncology Abstract - Patient Safety in Clinical Trials
"Patient Safety in Oncology Clinical Trials" is an interview with James T. Gourzis, M.D., Ph.D. Dr. Gourzis has more than 30 years of experience in designing and leading clinical trials, implementing regulatory strategies and negotiating licensing transactions. He provides consulting services to a wide range of biotechnology and medical device companies with respect to scientific, strategic and regulatory considerations associated with drug and biologic development.
Patient safety has always been the industry's focus during clinical trials. However, a recent spate of well-publicized patient safety issues has increased public scrutiny and the industry's desire to improve study quality, resulting in larger, longer, more expensive trials.
In the piece, Dr. Gourzis discusses a variety of critical issues affecting patient safety:
| | - Factors that have launched patient safety to the forefront of public scrutiny, including the effects of increased reporting requirements;
- What to look for when evaluating CRO excellence and commitment to patient safety;
- Unique safety considerations in oncology trials and the ramifications of the rare toxicity;
- Optimizing the role of the Data Monitoring Committee;
- Budget decisions that support patient safety;
- The evolution and future of FDA regulations.
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About Medelis, Inc.
Medelis, Inc. is a single-source provider for oncology CRO and oncology drug development services, providing a total solution for biotechnology and pharmaceutical companies seeking rapid drug development and approval. Medelis' medical founders, team physicians and clinical trial management physicians are internationally-recognized oncology thought and opinion leaders who understand the future of personalized medicine and threshold of credibility trials. Offerings include strategic plans for regulatory approval from phase I through NDA and complete oncology clinical trial design, management and execution.
Medelis is privately-held and located in Phoenix, Arizona.
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