Late phase trials aim to test whether a new treatment is better than an existing treatment.
The Cancer Research UK (CRUK) website has information about the different phases of clinical trials.
NIHR Clinical Research Network
Late Phase and International Trials form the largest area of the NIHR Clinical Research Network (CRN) Cancer Portfolio and include some of the most diverse and complex trials delivered by the NIHR.
Dr Pippa Corrie
Dr Pippa Corrie is the NIHR CRN National Specialty Lead for Late Phase and International Trials and the local lead for CRN Eastern. She also Chairs the CRN Cancer Specialty Group. If you would like to get in touch with the Cancer Specialty Group please contact crnspecialtyclusterf@nihr.ac.uk.
Early phase trials look at whether a drug or treatment is safe and tolerable and may provide early evidence of anticancer effects.
The Cancer Research UK (CRUK) website has information about the different phases of clinical trials.
NIHR Clinical Research Network
Early Phase Trials form the second largest area of the NIHR Clinical Research Network (CRN) Cancer Portfolio.
Professor Sarah Danson
Professor Sarah Danson is the NIHR CRN National Specialty Lead for Early Phase Cancer Research and chairs the Early Phase Leads Group. The main aim of this role is to improve equity of access to early phase trials. If you would like to get in touch with the Early Phase Leads Group please contact crnspecialtyclusterf@nihr.ac.uk.
Research infrastructure to support early phase trials
Experimental Cancer Medicine Centres
The NIHR funds 14 Experimental Cancer Medicine Centres across England in close partnership with Cancer Research UK. ECMCs act as an efficient and effective UK-wide network for delivering pioneering, early-phase cancer trials, bringing together world-leading laboratory and clinical researchers to test new treatments for adults and children with cancer.
NIHR Biomedical Research Centres
NIHR Biomedical Research Centres (BRCs), partnerships between England’s leading NHS organisations and universities, bring together academics and clinicians to translate lab-based scientific breakthroughs into potential new treatments, diagnostics and medical technologies. The following BRCs undertake cancer research:
NIHR Clinical Research Facilities
NIHR Clinical Research Facilities (CRFs) are purpose built facilities in NHS hospitals where researchers can deliver early-phase and complex studies. The following CRFs undertake cancer research:
Clinical Trials Units
There are a number of Clinical Trial Units that have experience and expertise with early phase trials.
- Significant upfront planning is required at the trial design stage, so involve CTUs early
- Early phase trials can have less patients than later phase, but may require more resource by the CTU and site (early resource review, planning and costing)
- CTUs will work very closely with early phase sites to establish collaborative working arrangements – data collection, site visits, regular phone contact
Much of the innovation in cancer treatment comes from radiotherapy research.
NIHR Clinical Research Network
This area of the NIHR Clinical Research Network (CRN) Cancer Portfolio is characterised by technological advances such as intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), stereotactic body ablative radiotherapy (SABR) and of course the newest addition Proton Beam Therapy (PBT).
Professor Jonathan Wadsley
Professor Jonathan Wadsley is the NIHR Clinical Research Network (CRN) National Specialty Lead for Cancer Radiotherapy and Imaging Research. He also chairs the Radiotherapy and Imaging Leads Group. If you would like to get in touch with the Radiotherapy and Imaging Leads Group please contact crnspecialtyclusterf@nihr.ac.uk.
Response Evaluation Criteria In Solid Tumours (RECIST) guidance (costings for reporting of specific scans)
In 2019, the NIHR conducted a scoping exercise to understand the variations in cost attribution associated with RECIST reporting. Following on from the scoping exercise a consensus statement has been developed which details that RECIST reporting is a research cost.
Radiotherapy Trials Quality Assurance (RTTQA) guidance (costings associated with quality assurance)
In 2010, the Department of Health and Social Care agreed that clinical trial QA is over and above routine QA, and therefore should be defined as an NHS service support cost and funded through local CRN funding. A consensus statement will be available in October.
Surgical oncology is vital in improving outcomes. Surgical technologies advance rapidly with a new era of diagnostics, robotic surgery, minimal access techniques, pre-optimisation and enhanced recovery. These innovations need proper evaluation in clinical trials to demonstrate which are clinically beneficial and cost-effective. Additionally, surgeons are often central in recruitment to the wider portfolio of multidisciplinary cancer trials. For example, surgeons are needed to help lead and recruit to window-of-opportunity studies and to assist in procurement of biospecimens for translational studies.
NIHR Clinical Research Network
The Network has a number of key initiatives which aim to encourage recruitment to surgical oncology trials. How we link with stakeholders.
Dale Vimalachandran
Dale Vimalachandran is the NIHR CRN National Specialty Lead for Surgical Oncology.
Defining and closely monitoring recruitment to portfolio of surgical trials
In order to better understand the trends, the NIHR reviewed the Cancer Portfolio to identify cancer trials that are recruited by surgeons. These trials include not only those where surgery is the primary trial intervention but also multi modality trials where the surgeon leads recruitment.
From April 2015 to March 2019 there have been 174 surgical oncology trials open and recruiting. On average there are over 100 surgical oncology trials open in a year with recruitment just over 12,000 in 2018/19. Over 8,000 of these recruits were to randomised controlled trials, 72 per cent recruited to time and target.
Training and mentorship
GeneRAtiNg sUrgicaL rEcruiters for randomised trials (GRANULE)
The GRANULE course is designed to equip researchers with the practical skills to recruit patients into randomised surgical trials. Find out more and register for this course on NIHR Learn.
The success of treating children with cancer has very much relied on their access to novel treatments through clinical trials but there is still much to be done in particular age groups. Cancer registration in the United Kingdom for children is from birth to 14 years (i.e. before their 15th birthday) and for teenagers and young adults is from 15 years to 25 years.
Currently for 0-14 year olds recruitment to clinical studies far exceeds the incidence of cancer in this age-group because some children participate in more than one clinical study during the course of their treatment. With our Teenage and Young Adult Cancer Strategy detailed below we hope to achieve the same for the 15-25 age range.
NIHR Clinical Research Network
The Children and Young People's Cancer subspecialty of the NIHR Clinical Research Network (CRN) Cancer Portfolio spans the 0-25 age range. This subspecialty is characterised by initiatives to increase accessibility to new drugs for paediatric cancer patients and understand how to increase research opportunities for Teenage and Young Adult cancer patients. It is the smallest area of the Cancer Portfolio.
Dr Martin Elliott
Dr Martin Elliott is the NIHR CRN National Specialty Lead for Children and Young People’s Cancer. Dr Elliott chairs the Teenage and Young Adult Cancer Steering Group. If you would like to get in touch with the Steering Group, please contact crnspecialtyclusterf@nihr.ac.uk.
Teenage and Young Adult (TYA) Cancer Strategy
In 2015, the Independent Cancer Taskforce noted that, in comparison with children under 16 years, the outcomes for older teenagers and young adults are improving less rapidly, and that TYA cancer patients are less likely to participate in research (Achieving world-class cancer outcomes: One year on 2015-16). It recommended:
“NHS England should ask NIHR and cancer research charities to consider ways in which access to clinical trials for teenagers and young adults with cancer could be significantly increased. NHS England should set an expectation that all centres or designated units treating TYA patients should aim to recruit at least 50% of those patients to clinical trials by 2025.”
To address this NIHR convened the first of two Summit meetings in May 2017 to explore ways to increase opportunities for TYA participation in NIHR Portfolio studies; to understand the structural and infrastructure factors that impact on TYA participation in clinical research and to develop combined stakeholder approaches to meet the Cancer Taskforce recommendation. The Summit met again in April 2019 to assess progress against the Strategy objectives, consider new developments and to refresh the Strategy.
The current Strategy focuses on the fundamental issues such as the development of national systems to give vital demographic data about participants in clinical research in any specialty area and not just cancer, further roll out of the identification of the TYA specific research nurse across the 15 Local Clinical Research Networks to help coordinate research opportunities for this patient group across the Network; increasing research opportunities for this patient group through collaboration with the NCRI TYA and Germ Cell Tumour Research Group and in line with the James Lind Alliance TYA Cancer and the Living with and beyond cancer Priority Setting Partnerships. Work with charities and of course working with stakeholders to increase awareness of research opportunities for TYA cancer patients using their established platforms.
If you have any questions about the Strategy or would like a copy please contact crnspecialtyclusterf@nihr.ac.uk.
Accelerate FAIR Trials Working Group
The FAIR Trials Working Group is part of the ACCELERATE forum (the key European organisation aiming to accelerate innovation in drug development for children and adolescents with cancer). It advocates the development of more inclusive studies where the age of entry corresponds to the biological age range of the disease rather than arbitrary age limits. Their key proposal is for the age of entry to be reduced to 12 years in adult early phase studies (where medically justified). The group is composed of clinicians, researchers, pharmaceutical companies, parents, patients and survivors from a number of European Countries.
The CRN Cancer Specialty were invited to join the FAIR Trials Working Group in February 2018 with a view to facilitating the implementation of the FAIR principles into UK clinical research. Since then, the Specialty has taken on the role of managing the activities of the UK contingent of the Working Group to ensure a coordinated response from the UK.
The principles of the Group are in direct alignment with the NIHR TYA Strategy, the aim of which is to help increase recruitment opportunities for TYA cancer patients. In the latest refresh of the Strategy a specific work stream has been dedicated to facilitating a dialogue with key audiences such as pharma and researchers about the benefits of lowering the age of entry to trials to correspond with the biological age range of a disease and what we can do to support them putting this into practice.
Supportive and community-based research refers to a broad range of end of life, palliative care and primary care across different disease groups (although the focus here is cancer) and settings such as hospices, homes and pharmacies.
NIHR Clinical Research Network
The NIHR Clinical Research Network (CRN) supports cancer research in supportive care and community settings such as hospices. In the last five years 72 hospices across the UK have been research active. The hospices have:
- Supported 52 studies on the NIHR Clinical Research Network (CRN) Portfolio, 30 of these are cancer studies
- Recruited over 5,000 people into the studies
- Over 4,250 of these people were recruited into the cancer studies
The number of research active hospices is drawn from the NIHR Central Portfolio Management System. These hospices have recruited people into NIHR CRN Portfolio studies between April 2015 to March 2020.
Due to local recruitment accrual and governance processes, recruitment of participants from hospice sites may have been attributed to the local NHS trust that provided research and development approval. It is therefore likely that the number of hospices recruiting to NIHR CRN Portfolio studies is higher.
The NIHR and Charities Consortium for Hospice and Community Research
The Consortium was launched in 2017 to bring together the NIHR CRN and many of the wide range of UK charities which are involved in supportive and palliative care, hospice and community care. Although it is the CRN Cancer Speciality that supports the Consortium, our scope extends beyond cancer research. The aim of the Consortium is to ensure that the UK becomes a global leader in the area of supportive and palliative care, hospice and community research by 2022.
If you or your organisation is interested in joining the Consortium please contact crnspecialtyclusterf@nihr.ac.uk.
