Clinical practice

Clinical practice

Information is available here to support building understanding of how clinical sites deliver advanced therapies to patients, including details of patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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pdf
01/06/2020

Apheresis process flow

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis.
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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
04/09/2023

Evaluation of the Gene Therapy Patient Referral Pathways in the UK

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Online Article
01/07/2020

In Vivo (virus based) gene therapy medicinal products – pharmacy institutional readiness guidance

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.
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Online Article
01/01/2020

Medication restrictions for patients having CAR-T-cell therapy

There are a number of restrictions in medicines allowed (and wash-out periods recommended) for patients on CAR-T Cell therapy at each stage of the pathway (apheresis lymphodepletion CAR-T infusion). This guidance has been produced by the Pan UK Pharmacy Working Group for ATMPs to document useful medication restriction information for CAR-T Cell therapy.
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pdf
01/06/2020

Neurotoxicity assessment for CAR-T cell therapy

A tool to assess for and grade Immune Effector Cell Associated Neurotoxicity Syndrome neurotoxicity in a CAR-T therapy patient.
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pdf
19/02/2024

Recommendations for Gene Therapy Patient Referrals Pathway

A summary of recommendations for Gene Therapy Patient Referrals Pathway
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pdf
19/02/2024

Recommendations for Gene Therapy Patient Referrals Pathway Infographic

An infographic capturing the recommendations for Gene Therapy Patient Referrals Pathway.
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pdf
29/04/2021

Recommendations on the procurement of starting materials by apheresis for ATMP manufacture

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation.
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pdf
08/06/2023

Referring Sarcoma Patients for Cell Therapy Clinical Trials: A UK Wide Survey of Current Referral Routes and Practices to Identify Gaps in the Referrals Process and Maximise Patient Access to Cell Therapy Clinical Trials

A UK Wide Survey of Current Referral Routes and Practices to Identify Gaps in the Referrals Process and Maximise Patient Access to Cell Therapy Clinical Trials.
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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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Online Article
11/07/2022

Supportive Medicines for Adults Receiving Marketed CAR-T Cell Therapy

Prior to receiving CAR-T cell therapy patients will receive lymphodepletion chemotherapy.  CAR-T cell therapy and lymphodepletion regimes can increase the likelihood of certain side effects and infections so supportive medicines are recommended.These consensus recommendations prepared by the Clinical Pharmacy subgroup of the Pan UK Pharmacy Working Group for Advanced Therapy Medicinal Products (ATMPs) relate to supportive medicines recommended for adults receiving licensed CAR-T cell therapy.
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pptx
01/06/2020

Thawing and visual inspection of cell therapy medicinal products

A training resource on the importance of correctly thawing and inspecting cell therapy medicinal products.
Downlaod PPTX

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Explore all toolkit sections

  • Governance

    Governance

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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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