A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice

Published:September 10, 2018DOI:


      • This review provides a system-based practical approach for the safe implementation of targeted and immune therapies.
      • Creation of a multidisciplinary EDDIT team can provide shared experience and enhanced patient safety.
      • Education of providers, staff, trainees, and patients is a key function of the EDDIT team.
      • Immediate access to expert advice serves to avoid delays in recognition and management of adverse events.


      The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potentially life-threatening toxicities and many require special multidisciplinary logistical considerations. The objective of this review is to describe a practical approach for the safe implementation of targeted and immune therapies in academic gynecologic oncology practices based on our experience at M.D. Anderson Cancer Center.


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