Webinar: Microbiology Operations in Infectious Disease Clinical Trials

A user's guide for effective anti-infective development

Understanding and managing the microbiology component is critical for the clinical development of infectious disease therapeutics and requires the closely coordinated efforts of the Infectious Disease Physician, Clinical Microbiologist and Clinical Development Operations staff. From a strategic perspective, the choice of targeted indications and pathogens, and ultimately the approved indications, are driven in large part by an understanding of the microbiological and pharmacodynamic properties of the investigational product. From the operational perspective, microbiologic considerations must be woven into each step of the trial process; these include country and site selection, vendor (lab and PK) selection and management, data management, analysis and CSR development.

Appropriate training is essential in all functions and process oversight by qualified staff is important for on-going trial stewardship. Operational expectations and performance indicators for the microbiologic objectives must be set and closely monitored in an informed manner. Integrating and aligning microbiology and clinical endpoint management optimizes trial performance and is essential to mitigate risk. Beyond the immediate trial needs, the strategic leadership must be forward looking to provide support for the target label objective, monitoring resistance development, planning breakpoints and preparing the marketing application.