Advanced Therapies NHS Readiness Toolkit
Clinical TrialsThis 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 overviewThis section features The NIHR Clinical Trials Toolkit and The ABPI ATMP road mapView Resources
Trial GovernanceInformation 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 MaterialsInformation and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:View ResourcesSolid 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)
Receipt, storage & issue of advanced therapiesAvailable 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.View Resources
Pharmacy considerationsThe considerations for hospital pharmacy departments delivering advanced therapies, including:View ResourcesReceipt, 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.
Clinical management of patients at siteIncludes 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.View Resources
Education and trainingThis 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.View Resources
Performance management and metricsAn 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.View Resources
National infrastructure, templates and guidanceLinks 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.View Resources