Operational delivery

Clinical management of patients at site

Clinical management of patients at site

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pdf
27/02/2023

All CAR-T follow up checklist

Please click here for CAR-T follow up checklist
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pdf
01/06/2020

Cytokine release syndrome assessment for CAR-T therapy – Newcastle Hospitals

A tool to assess for, and grade, cytokine release syndrome in a CAR T therapy patient
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Online Article
04/12/2020

Diagnosis and medical management of acute CAR-T cell toxicities in adults

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.
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pdf
27/02/2023

Diffuse large B cell lymphoma (DLBCL) CAR-T follow up checklist

DLBCL CAR-T follow up checklist.
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pdf
27/02/2023

Guidelines for management of Cytokine Release Syndrome

Policy and guidelines on the management of Cytokine Release Syndrome with cellular therapies (notably CAR-T cells) and bi-specific T cell engaging antibodies (eg blinatumomab).
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Online Article
16/12/2020

Management of GMO Spillage or Accidental Exposure in a Clinical Area – example SOP

This SOP considers general principles for the management of a Class 1 or 2 GMO gene therapy spillage or accidental exposure in a clinical area.
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pdf
27/02/2023

Medical Assessment of patients for bone marrow harvest or therapeutic apheresis

Template proforma for medical assessment of patients for bone marrow harvest or therapeutic apheresis
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pdf
23/08/2022

SOP – Shared Care for Adult CAR-T Patients

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust detailing effective shared care between the treatment centre and referring centre.
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pdf
27/02/2023

SOP: CAR-T therapy discharge and follow up. CAR-T service pathway – post infusion

SOP for safe discharge and follow-up for patients, post Chimeric Antigen Receptor (CAR) T-cell therapy infusion.
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pdf
14/10/2021

SOP: Handling and Administration of In vivo GMO Gene Therapies

This example SOP considers general principles for the handling and administration of an example in vivo GMO gene therapy in a clinical area which can be adapted to accommodate local procedures or product-specific requirements.
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pdf
27/02/2023

SOP: Infusion of cellular products

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.
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pdf
27/02/2023

SOP: Inpatient Management of Patients Receiving Immune Effector Cells (Including CAR-T Cells)

Outline guide for management of inpatients receiving immune effector cells
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pdf
27/02/2023

SOP: Training for Pharmacists involved in Haematopoietic Cellular Therapies

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.
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Explore all clinical trials sub-sections

  • Advanced therapy clinical trials process overview

    Advanced therapy clinical trials process overview

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    This section features The NIHR Clinical Trials Toolkit and The ABPI ATMP road map

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  • Trial Governance

    Trial Governance

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    Information regarding the governance arrangements required within the NHS to approve, set up and manage clinical trials of advanced therapy investigational products is included here, with details on local governance, committees, feasibility and risk assessments.

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  • Procurement of Starting Materials

    Procurement of Starting Materials

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    Information and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:

    • Solid tumours A suite of SOPS by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (Tils)
    • Blood (aphaeresis) A suite of SOPS for adoptive cellular therapy (Immune Effector Cells)

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  • Receipt, storage & issue of advanced therapies

    Receipt, storage & issue of advanced therapies

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    Available here are examples of checklists and templates for the safe receipt, storage and issue of advanced therapies within the NHS.

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  • Pharmacy considerations

    Pharmacy considerations

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    The considerations for hospital pharmacy departments delivering advanced therapies, including:

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  • Clinical management of patients at site

    Clinical management of patients at site

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    Includes exemplar SOPs and information regarding the clinical management of patients receiving advanced therapies in a hospital setting, covering patient consent, treatment, management of toxicities and follow-up care.

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  • Education and training

    Education and training

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    This section includes links to webinars, e-learning modules and a range of resources, to assist all staff delivering advanced therapy trials in an NHS setting.

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  • Performance management and metrics

    Performance management and metrics

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    An outline of the barriers to effective advanced therapy clinical trial set up, changes to overcome these barriers, and the key metrics to measure success in terms of trial set up and patient referral and recruitment is available here.

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  • National infrastructure, templates and guidance

    National infrastructure, templates and guidance

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    Links to information on the national infrastructure surrounding the clinical trial application process, also further guidance, and templates to assist in the set up and delivery of advanced therapy clinical trials. Including examples of model ATiMP clinical trial agreements.

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    • Explore all toolkit sections

  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

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    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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