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Assessment of the safety of advanced therapy medicinal products (ATMP) process: a tutorial video creation module
European Statement
Patient Safety and Quality Assurance
Author(s)
Chloé JADOUL, Audrey DURAND, Rémy TORDJEMAN, Isabelle MADELAINE, Romain de JORNA
Why was it done?
With the development of advanced therapy medicinal products (ATMPs), a specific pharmaceutical process is necessary to secure the handling of genetically modified organisms. Gene therapy includes Chimeric Antigen Receptor T (CAR-T) cell therapy as well as clinical trials with oncolytic viruses and nucleic acids. Limited experience on these new activities and high staff turnover based on resident pharmacist explain the need of additional training material to supplement written procedures. Multimedia support seems to be the most appropriate didactic tool.
What was done?
The objective of this work is to create pedagogical tools as short video clips. The final aim is to standardise hands-on training in order to improve ATMPs circuit safety.
How was it done?
All steps of each activity were listed and filmed in order to create a video database. Clinical trial mock preparations were performed to create the clinical trial tutorials whereas CAR-T cell activities were filmed in real conditions.
Clipchamp (Microsoft) video editing software is used to create tutorial videos. Repetitive parts were edited once and reused for other videos. They are part of the database videos.
As a validation, all staff members’ approbation was required.
What has been achieved?
Activities include, to this day, five gene therapy clinical trials and the CAR-T cell activities: reception, shipment to the pharmaceutical hub, thawing and distribution.
We filmed 55 step clips and edited six repetitive parts. Finally, eight tutorial videos were created: three for clinical trials and four for different CAR-T cell activities.
To make the training more meaningful, we made dynamic videos that last no more than 5 minutes. The average time of a tutorial was 2 minutes 17 seconds.
What next?
The tutorial videos bank is created to be dynamic and can be easily adjusted. Videos of repetitive parts will be reused for new clinical trials implementation. These video tutorials allow new resident, student or technicians to be trained faster and in a more innovative way. They also allow permanent teams to benefit from a quick refresh. In order to assess the efficiency of this new process, next operators will have to read the procedure, watch the videos and will be evaluated in practice.