Patient safety abstract available for download

Medelis has just published “Patient Safety in Clinical Trials:  A Q&A with James T. Gourzis, M.D., Ph.D.” It’s 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.

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

You can download the abstract here and sign up to receive future publications in the series as well.