Policy Research Unit on Awareness, Early Detection and Screening

University of Leicester requires access to the NDRS Cancer Registrations data set for the purpose of the below research project:

Policy Research Unit on Awareness, Early Detection and Screening

The following is the summary of the aims of the research project provided by or on behalf of the University of Leicester:

• Track trends over time in various early diagnosis markers (e.g., stage at diagnosis, ‘emergency presentation’, screening detection status) with attention to key demographic and geographic groups.)

• Track trends in stage-specific net survival among cancer cases overall and by specific population groups. Analysing these trends separately by key population groups of interest.

• Develop and apply causal inference methodologies to assess relationships between diagnostic stages, routes, and survival outcomes, aiming to understand how these relationships evolve over time.

• Quantify potential survival gains from targeted improvements in early diagnosis markers and reducing related inequalities.

• Collaborate with NHS England to build public health data science capacity and create a toolkit for monitoring early diagnosis trends, integrating it into routine NHS surveillance. The policy research unit is funded by NIHR, but has direct input from an Oversight Group based at the Department of Health to ensure policy-relevant research. If new techniques are developed for monitoring early diagnosis as part of this programme of research – the intention would be for those to be routinely adopted by NHS England directly

• Estimate the impact of early diagnosis initiatives by calculating stage-specific survival estimates under different stage distribution scenarios, while developing methodologies for survival extrapolation and imputation of missing data.

• Incorporate granular stage information (e.g., Tumour, Node, Metastasis TNM stage categories) into calculations to improve precision beyond a simple early/late-stage dichotomy.

• Develop methods to address lead-time bias when comparing survival rates across diagnostic routes with different lead intervals.

• Explore intersectional inequalities in survival and early diagnosis markers by developing methodologies to assess the effects of multiple mediators across different population groups.

The following NHS data will be accessed:

• NDRS Cancer Registration Data - necessary because individual level information on each patient diagnosed with cancer is required to ascertain an individual’s survival time given their patient characteristics (e.g. cancer type, age, sex, stage etc.). This individual-level data will be used to calculate stage-specific survival, as well as monitoring key trends in early diagnosis (such as stage distributions, and the proportion of cases that are diagnosed as emergency). The modelling techniques that are required for the casual inference approaches require individual record level data on the date of diagnosis, and the date of event (be that alive/censored or all-cause death).

The level of data will be pseudonymised

The data will be minimised as follows:

• The data requested will be limited to adults age 18-99 who fall under specified ICD-10 Codes covering the following cancer sites/morphologies/behaviour: Bladder; Breast (females only, excluding Paget’s disease); Cervix (females only); Colon; Hodgkin lymphoma; Kidney; Larynx (including anterior surface of epiglottis); Lung; Melanoma of skin; Non-Hodgkin lymphoma; Oesophagus (including oesophagogastric junction); Oral cavity, hard palate and lip (inner aspect); Oropharynx, base of tongue, tonsil, soft palate and uvula; Ovary, fallopian tube and primary peritoneal carcinomas (females only); Pancreas; Prostate (males only); Rectum; Stomach (excluding oesophagogastric junction); Testis (males only); Thyroid.

• Data will be limited to patients diagnosed between the beginning of the year 2000 & the latest date available at extraction.

• The data being requested will contain no exact dates and be inclusive of year and month only.

• Should a patient have more than one tumour for the same site only data relating to the tumour diagnosed first will be provided.

The University of Leicester is the research sponsor and controller, responsible for ensuring the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The outputs from this project will quantify potential survival gains from targeted improvements in early diagnosis markers and measure the impact of reducing related inequalities. University of Leicester will also explore intersectional inequalities in survival and early diagnosis markers by developing methodologies to assess the effects of multiple mediators across different population groups. The further understanding that stems from this project will reduce inequalities and lead to future improvements in survival, directly in the public interest.

The funding is provided by National Institute for Health and Care Research (NIHR). The funding is specifically for the project described. Funding is in place until 31st December 2028.

The funder will have no ability to suppress or otherwise limit the publication of findings.

The University of Leicester obtained appropriate patient and public involvement and will continue to do so regularly through the PPIE Panel of the Policy Research Unit. This will involve periodic updates to PPIE volunteers and sharing of methodology and findings as they emerge. University of Leicester have previous experience of interacting with a Cancer Research UK patient sounding board for methodological development projects – ensuring that they use sensitive wording in the communication of statistics in relation to death and mortality.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from NDRS Cancer Registration dataset to The University of Leicester. The Data will

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Leicester.

The University of Leicester’s research file storage backup is onsite, managed in-house and owned by the University of Leicester.

The Data will be accessed onsite at the premises of University of Leicester or the Data will be accessed by authorised personnel via remote access.

The University of Leicester confirms and can provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England/Wales at any time.

Access is restricted to employees of the University of Leicester who have authorisation from the Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts/researchers from the University of Leicester will process/analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• Develop methodologies to improve and monitor early cancer diagnosis, increasing the chances of effective treatment and better patient outcomes.

• Identify and address inequalities in cancer diagnosis by monitoring trends across different patient groups, ensuring improvements are distributed equitably across demographic, geographic, and socioeconomic groups.

• Link improvements in diagnostic processes to better stage-specific survival rates, helping to understand how earlier diagnosis translates into longer survival and improved patient care.

• Identify groups and areas where progress toward earlier diagnosis is slower, enabling focused interventions to accelerate progress and reduce disparities.

• Develop an early diagnosis monitoring toolkit for NHS England, contributing to routine surveillance and guiding policy decisions to meet the 2028 target of 75% early-stage cancer diagnosis.

• Strengthen data science capabilities in public health through collaboration with NHS England, improving the ability to monitor, assess, and respond to trends in cancer diagnosis and survival.

• Facilitate routine reporting of early diagnosis and survival metrics at the level of NHS organizations, supporting continuous monitoring of progress and informing necessary corrective actions.

• Provide detailed evidence on how earlier cancer diagnosis impacts the entire treatment pathway, from diagnosis to survival, helping to improve patient care strategies.

• Publish approximately 10 papers in high-quality, peer-reviewed biostatistical and cancer epidemiological journals.

• Quantify the potential survival benefits that could be achieved through targeted improvements in early diagnosis markers, leading to better-informed clinical and public health interventions.

• Provide regular updates and share methodology and findings with patient and public involvement volunteers via the PPIE Panel of the Policy Research Unit.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived

The outputs will be communicated to the relevant recipients through the following dissemination channels:

• Journals

• Social Media

• Press/Media Engagement

The study team expect that outputs will be disseminated by the end of 2028.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

Primarily the findings are expected to produce statistical methods that may help improve the validity of future health-related research focused on the early diagnosis of cancer. This in turn may contribute to evidence-based decision-making for policymakers, and healthcare professionals, and inform best practices to improve the care, treatment and experience of healthcare users and patients. Any improvements in future early diagnosis of cancer will hopefully lead to improved outcomes for future cancer patients.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, by developing strategies for the targeted awareness campaigns to reduce the inequalities in early diagnosis markers that are highlighted in this research project. This project sits in a wider programme of work that looks to explore all the avenues for reducing

inequalities and improving the early diagnosis of cancer.

Yielded Benefits is not a requirement for new applications.