Cancer survival methodological developments and their applications

The University of Leicester requires access to NHS England National Disease Registration Service (NDRS) Data for the purpose of the following research project: Cancer survival methodological developments and their applications.

The objectives of the project are as follows:

PRIMARY OBJECTIVES

1. Develop novel statistical approaches to report the impact of a cancer diagnosis at an individual level based on key patient characteristics both in terms of survival following a cancer diagnosis and in terms of quality of life.

2. Develop methodology in the same modelling frameworks to assess the impact of interventions (e.g., screening, and early diagnosis campaigns) or of the global pandemic due to COVID-19 (and corresponding restrictions) on the stage profile and outcome for cancer patients.

3. Develop approaches to better inform the impact of increased survival from new treatment interventions, by selecting nationally representative samples of patients, and using the developed methodology in survival curve extrapolation and marginalisation.

SECONDARY OBJECTIVES

1. Assess loss of life expectancy and loss of quality of life after cancer diagnosis for a range of cancer sites.

2. Estimate patterns of causes of mortality following a cancer diagnosis; and the long-term impact of a cancer diagnosis on other causes of mortality.

3. Provide long-term survival estimates according to the stage of cancer.

4. Estimate the impact of early diagnosis initiatives by calculating extrapolated stage-specific survival estimates assuming different underlying stage distributions.

5. Estimate the impact of achieving stage profiles of cancer patients in other countries by calculating stage-specific survival estimates assuming different underlying stage distributions.

6. Assessing the impact of pandemic-impacted lifetables on the estimation of cancer patient survival.

7. Using the excess mortality rate of cancer patients to assess the impact of the shift in timing and routes to diagnosis during 2020.

8. Create approaches to simulate nationally representative samples of cancer patients for given targeted populations for interventions, allowing tailored projections of treatment effects for a more realistic population.

As outlined above in the primary objectives the key reason for the data processing is to develop and show the benefit of the use of new statistical methods when using largescale population-level data such as that recorded as part of national cancer registration. These new methods will be widely used by applied researchers when assessing the impact of early diagnosis initiatives in cancer, understanding the impact of the pandemic on cancer outcomes, and assessing the benefit of novel cancer treatments when applied to the whole population (rather than isolated to a clinical trial population). The secondary objectives listed for the use of the data will also offer key exemplars of how these new methods can be applied to real-world data and offer key insights for cancer patients, clinicians and policy makers. This will aid future cancer research in utilising these key data resources.

The following NHS England NDRS data will be accessed in support of these aims:

• NDRS Cancer Registrations

• NDRS Quality of Life of Colorectal Cancer Survivors in England

The data being accessed will be record-level pseudonymised data.

The NDRS Cancer Registry data will be minimised as follows:

• The data requested will be limited to adults 18-99 (inclusive) who fall under specified ICD-10 Codes covering the following cancer sites/morphologies/behaviour: Colorectal, Bladder, Breast, Lung, Prostate, Hodgkin Lymphoma, Cervix, Stomach, Ovarian and Melanoma

• Data will be limited to patients diagnosed between January 1st 2000- December 31st 2020

• 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 NDRS Quality of Life of Colorectal Cancer Survivors in England data will be minimised as follows:

• The data requested will be limited to adults 18-99 who have a diagnosis of colorectal cancer

• Only responses to questions that are necessary and relevant to the aims of the research have been requested

The University of Leicester has engaged in detailed conversations with the NDRS Analytical team to ensure that the data being requested is adequate, relevant and limited to what is necessary.

The University of Leicester will focus the majority of the outputs on the last 10 years of data. However, to estimate long-term survival estimates (i.e. life expectancy) there will be some added value in having up to 20 years of follow-up as a way to ensure that for cancer sites with long-term excess mortality the study team use the long-term data available to check if model-based estimates on the recent data are consistent to what has been observed in the past. The level of data could not be reduced without affecting the project's stated aims.

The University of Leicester is the sole controller and determines the purpose and means of processing for data being disseminated under this Agreement. The University of Leicester is responsible for ensuring that the data will only be processed for the purposes described above.

The lawful basis for processing personal data under the UK General Data Protection Regulation (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.

Funding for this project has been provided by Cancer Research UK. The funding is specifically for the project described within this Agreement. Cancer Research UK will have no ability to suppress or otherwise limit the publication of findings.

Individuals substantively employed by the Karolinska Instiutet, University College London (UCL) and the International Agency for Research on Cancer (IARC) act in an advisory capacity. These individuals have not been involved in determining the purpose and means of the processing and will not receive access to the data being provisioned under this Agreement.

In line with the National data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and (11) of the National Health Service Act 2006

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

No data will flow into NHS England for the purposes of this Agreement.

NHS England will provide the relevant records from the NDRS Cancer Registry and the NDRS PROMs (Colorectal) to the University of Leicester. The data will contain no direct identifying items, the data will be pseudonymised and individuals cannot be reidentified through linkage with other data in possession of the recipient.

Once the University of Leicester has received the data, the data will not be transferred to any other location.

The data will be stored on servers at the University of Leicester. Backup servers are located on-site.

The data will be accessed by authorised personnel via remote access on University equipment only and only via a secure VPN. The data will always remain on the servers at the University of Leicester.

The data will not leave or be accessed outside of England and Wales at any time.

Access is restricted to substantive employees of the University of Leicester who have authorisation from the Principal Investigator. All those accessing the data have been appropriately trained in data protection and confidentiality.

The data that is being provided under this Agreement will not be linked to any other data. While the study has access to data provided by the Clinical Practice Research Datalink (CPRD) there is no mechanism through which this data can be linked or pooled with data received from NHS England.

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

Researchers from the University of Leicester will process the data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer-reviewed journals, the study team plan to publish all statistical analysis code in peer-reviewed journals (e.g., Statistics in Medicine, International Journal of Cancer). The study team expect to be able to begin to make submissions at some point in 2024.

• Presentations at Conferences (e.g., the International Society for Clinical Biostatistics and the International Association of Cancer Registries Conference)

• The study team may look to create an interactive tool that provides summary statistics. Any such tool will be made publicly available and will be published on the University Webpages

The outputs will not contain any NHS England NDRS data and will only contain aggregated information with small numbers suppressed in line with the relevant disclosure rules.

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 2024.

Primarily the findings are expected to produce statistical methods that may help improve the validity of future health-related research focused on cancer survival. 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.

The statistical methods being produced may help researchers:

• Improve understanding of regional and national trends in health and social care needs

• Inform planning of health services and programme

• Inform decisions on how to effectively allocate and evaluate funding according to health needs

It is hoped that through the publication of findings in appropriate media the statistical methods developed will add to a growing body of methods that can be used by researchers to carry out research on cancer survival.

Furthermore, the summary statistics produced may contribute to evidence-based decision-making for policy-makers, and local decision-makers such as doctors, and patients to inform best practices to improve the care, treatment and experience of healthcare users.

The findings will be advertised to a wide audience to ensure maximum impact. CRUK, the study’s funder, may assist in ensuring that the findings reach the relevant communities.

Yielded Benefits is not a requirement for new applications.