Advanced therapy clinical trials process overview

Advanced therapy clinical trials process overview

Advanced therapy clinical trials process overview

Back to all clinical trials sub-sections
Online Article
27/02/2023

ABPI Roadmap

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring
Go to link
Online Article
27/02/2023

NIHR Clinical Trial Routemap

The NIHR Clinical Trial Routemap is an interactive colour-coded tool to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements, and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices, along with more detailed information available at ‘stations’ along the route.  
Go to link

Explore all clinical trials sub-sections

  • Advanced therapy clinical trials process overview

    Advanced therapy clinical trials process overview

    Read more about this section.

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

    View resources
  • Trial Governance

    Trial Governance

    Read more about this section.

    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

    Procurement of Starting Materials

    Read more about this section.

    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)

    View resources
  • Receipt, storage & issue of advanced therapies

    Receipt, storage & issue of advanced therapies

    Read more about this section.

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

    View resources
  • Pharmacy considerations

    Pharmacy considerations

    Read more about this section.

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

    View resources
  • Clinical management of patients at site

    Clinical management of patients at site

    Read more about this section.

    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.

    View resources
  • Education and training

    Education and training

    Read more about this section.

    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.

    View resources
  • Performance management and metrics

    Performance management and metrics

    Read more about this section.

    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.

    View resources
  • National infrastructure, templates and guidance

    National infrastructure, templates and guidance

    Read more about this section.

    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.

    View resources

    • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources
  • 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.

    View resources