The NCRI Pathology Group identified their strategic priorities in August 2022 to change the way pathologists engage with, conduct and are recognised for their work in clinical trials.
Identify the challenges of providing cellular and molecular pathology and laboratory medicine support for research in all cancer types and establish a consensus on ‘next generation’ pathology
By addressing this priority, we aim to establish a joint consensus on the future of ‘next generation’ pathology that is required to support clinical trials in all study areas across the UK. There will be a particular focus on research with personalised study designs and maximising the research value and utilisation of tissue or other clinical samples. The work of this group will also address ways to encourage collaboration in research as opposed tocompetition. Greater collaboration and data sharing will ultimately result in higher qualitymulti-centre studies. This working group will produce and publish a position paper addressing challenges such as:
- Early engagement of pathologists and other laboratory scientists in trial planning
- Profile and availability of trials-ready laboratory medicine staff
- Governance and value maximisation of trial-related clinical samples
- Sharing trial data and facilitating digital pathology research
This paper will also include a summary of the achievements from the previous 5-year strategy of the NCRI Pathology Group.
Develop CONSORT-Path guidelines
This working group will build on the foundations laid by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-Path Working Group to develop and publish guidance to address the variability in how cellular and molecular pathology activity, including eligibility and outcome assessment, in clinical trials is reported. To realise the benefits of this outcome the group will work to embed both Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT-Path guidelines into funder, regulator and industry practice.
Through this work we aim to increase the transparency of trial activity to allow more informed, rigorous assessment that ultimately increases confidence in reported trial data. Further, complete documentation and publication of the specific contributions of laboratory medicine staff to trial processes will raise their profile and increase awareness of the value of early engagement amongst future trial protocol authors.
Develop a code of practice to maximise the value extracted from clinical samples
This working group will develop a code of practice for retention and access to patient samples collected and stored for research use during a clinical trial. Participants in clinical trials regularly consent to provide blood, tissue, or other clinical samples for no immediate personal benefit. Such altruistic sample provision is critical to advance understanding. All those involved in trial execution should ensure that maximum value be extracted from the gifted material although no code of practice exists to formalise this.
By addressing this priority, we aim to provide a mechanism that allows trial sponsors and investigators to improve the governance of trial samples and permit the maximum research value to be gained from them, in accordance with the wishes of trial participants.
Support the development of a research ready workforce
There is a need to enhance training of those working in cellular and molecular pathology or as laboratory scientists so that staff have an understanding of future possible contributions to clinical trials.
By addressing this priority, we aim to encourage appropriately funded clinical work in laboratory medicine such that trials work is considered a routine and valued part of working life, beginning with input into the earliest phase of specialist training. This working group will engage with multiple stakeholders, including NIHR, RCPath and other learned societies to embed SPIRIT-Path and CONSORT-Path into training curriculums and as a separate clinical trials GCP course.
Maximise the value and utilisation of pathology images from UK clinical trials by computational methods
The aim of this priority is to define how the application of AI and digital pathology can complement traditional subjective pathological assessment and enhance the information yield from stained sections related to UK clinical trials. We aim to define a consensus road map for UK stakeholders in computational pathology that will maximise the value of stained sections and associated data from clinical trials. A clear route for developing digital pathology tools and workflows suitable for incorporation into routine practice will be established. We also aim to agree mechanisms for the deposition of clinical trials pathology images and data in the UK to promote cross-disciplinary studies that exploit these resources, improve trial transparency, and ensure maximum use of available data.
Establish a costing template for cellular and molecular pathology activity in clinical trials in the UK
By addressing this priority, we will allow cellular and molecular pathology activity to be included and appropriately costed in clinical trial protocols and associated application documents as they are being developed. This promotes early engagement with laboratory medicine staff including pathologists and laboratory scientists and is in keeping with SPIRIT-Path guidelines. This also ensures that cellular and molecular pathology laboratory activity in successfully funded trials can be undertaken efficiently and with minimal further negotiation during trial set-up.
Promote the development of laboratory medicine diagnostics that can be incorporated into established NHS laboratory medicine working practises
This priority aims to promote the development of laboratory medicine diagnostics, including biomarkers, that can be more easily incorporated into NHS laboratory medicine working practises. We intend to do this by highlighting the value of early engagement of NHS laboratory medicine staff, including cellular and molecular pathologists and laboratory scientists, through production of educational materials made freely available through appropriate channels. The production of these materials will sign-post those developing laboratory diagnostics who may not be familiar with the working practises of NHS laboratories towards engagement with subject-matter experts. This will allow clearer lines of sight towards clinical practice during development and increase the speed and efficiency with which new diagnostics and biomarkers can be of clinical benefit.