Advanced Therapies NHS Readiness Toolkit

Clinical Trials

This section has a range of resources 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.

Resources are organised in the categories shown below:

  • Advanced therapy clinical trials process overview

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

    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.View Resources
  • Procurement of Starting Materials

    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 TumoursA suite of SOPs by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (TILs)
    Blood (apheresis)A suite of SOPs for adoptive cellular therapy (Immune Effector Cells)
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  • Receipt, storage & issue of advanced therapies

    Available here are examples of checklists and templates for the safe receipt, storage and issue of advanced therapies within the NHS. These resources can also be accessed under Pharmacy Considerations.
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  • Pharmacy considerations

    The considerations for hospital pharmacy departments delivering advanced therapies, including:
    Receipt, storage & issue of advanced therapiesThe checklists and forms to ensure the safe receipt, storage, issue and delivery of these therapies across a hospital site.
    Site readiness and guidanceAdvice on costing advanced therapy clinical trials and guidance to ensure institutional readiness at sites.
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  • Clinical management of patients at site

    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

    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

    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

    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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