Katie M. Snell, United Kingdom
UCL Great Ormond Street Institute of Child Health Infection, Immunity and Inflammation Programme, Molecular and Cellular Immunology SectionPresenter of 2 Presentations
DEVELOPING A STANDARD OPERATING PROCEDURE FOR CLINICAL TRIAL ADVANCED THERAPY INVESTIGATIONAL MEDICINAL PRODUCT ADMINISTRATION; A SINGLE CENTRE EXPERIENCE.
Abstract
Background and Aims
Background: University Collage London’s Institute of Child Health in collaboration with Great Ormond Street Hospital (UCL GOS ICH) has delivered autologous Retroviral (RV) and more recently Lentiviral (LV) Gene Modified CD34+ cells for over 15 years. During this time clinical practices have developed and changed and trials have become increasingly complex with the additional layer of commercialisation. In the last five years the UCL GOS ICH gene therapy trials programme has rapidly expanded and the amount of advanced therapy investigational medicinal product (ATIMP) delivery has also thus increased. Our team has gained extensive knowledge which we have used this to develop a standard operating procedure (SOP) to standardise the delivery of ATIMPs. During the last 15 years, the team have encountered challenges including changing protocols, collaboration with commercial companies, damaged product bags and multiple good clinical practice audits.
Methods
Methods: Our team of three nurses documented every step of the process multiple times, then a different nurse audited and monitored the process multiple times to ensure the SOP reflected current practice.
Results
Results: Various Corrective and Preventative Actions (CAPA) and audit findings have been utilised to facilitate change and used to develop this SOP that will effectively standardise and safely deliver our Gene Therapy autologous Lentiviral Gene Modified CD34+ ATIMPs to the patients.
Conclusions
Conclusions: The authors have developed an SOP that standardises the safe delivery of ATIMPs in the clinical area. It details receipt of ATIMP in the clinical area to the safe administration and subsequent documentation of the administration.
THE ROLE OF THE CLINICAL RESEARCH NURSE IN ADVANCED THERAPY INVESTIGATIONAL MEDICINAL PRODUCT CLINICAL TRIALS; A SINGLE CENTRE REFLECTION.
Abstract
Background and Aims
Background: The National Institute for Health Research (NIHR) describes clinical research nurses as vital to delivering research with one of their strategic goals being “improve awareness and understanding of the speciality of clinical research nursing and its contribution and impact”. Advanced therapy investigational medicinal product (ATIMP) clinical trials are high risk requiring additional considerations.
Methods
Methods: I used a model of reflection, literature searches and learning from wider teams who participate in gene therapy trials alongside maximising opportunities to speak to gene therapy research nurses in other global leading centres.
Results
Results: I have divided the research nurse (RN) role into four sections. Education; an RN must be a clinical expert in ATIMP clinical trials, regulatory standards, monitoring and good clinical practice (GCP) audits. Part of the specialised role is to educate others including patients, families and the wider multidisciplinary team. Documentation; an RN must understand and sufficiently document the consent process ensuring the added risks of ATIMP clinical trials are understood and reflected in source data. They must thoroughly document the delivery of each ATIMP in the source data. Organisation; an RN must ensure that traceability is transparent and robust, and ensure the patient journey is according to the clinical trial protocol. Timely reporting of adverse events is critical. Challenges; frequent changes to clinical trial protocols means an RN must be adaptable and skilled at troubleshooting.
Conclusions
Conclusions: An RN in ATIMP clinical trials needs a willingness to learn and teach, strong organisational and documentation skills and an ability to rapidly overcome challenges.