Quality Assurance and Performance Improvement
Background : Clinical trials with oncolytic viruses, gene therapy, and other biologic agents are becoming more common in healthcare facilities but study protocols often do not include infection prevention (IP) practices. Although many of these biologic agents are unable to replicate, there is still concern for unintended exposures during the preparation and administration process that could lead to adverse outcomes in patients or employees. We implemented an IP review process for clinical trials with biological agents to ensure safe IP practices are followed.
Methods : A policy was created to outline IP requirements for clinical trials based on the type of biologic agent used and the route of administration. To facilitate a review process, IP was notified of new clinical trials with oncolytic viruses, gene therapy, and other biologic agents at the time of approval by the Institutional Biosafety Committee (IBC). Review included completion of a risk assessment and an in-person meeting to evaluate the IP practices included within existing study protocols. We specifically focused on protocols for safe preparation of the biologic agent in the pharmacy, safe handling during administration, isolation requirements during and after administration, and disinfection practices in all areas where the biologic agent is handled. Additional IP guidelines were created if limited or no guidelines existed.
Results : The review process was implemented in 2015 and IP has been notified of 32 new studies by the IBC. Supplemental IP guidelines were incorporated into existing protocols based on practices that were agreed upon during the review process.
Conclusions : Most clinical trials with oncolytic viruses, gene therapy, and other biologic agents lack sufficient IP guidelines in their study protocols. By developing an IP review process, clinical trials at our institution now have more robust IP guidelines in place to prevent unintentional exposures.