Descriptive Epidemiology, Treatment Patterns, and Outcomes of Patients with Renal Cell Carcinoma in England: A Retrospective Cohort Study Using SACT Data and Cancer Registry (DORCES) ( ODR2021_055 )

Evidera Ltd are requesting an extension to retain the data provided under DARS-NIC-656879 for a few months longer. Evidera Ltd are currently working on preparing a manuscript to disseminate results of the study. Therefore, Evidera Ltd are requesting that the data sharing agreement is extended in case Evidera Ltd are required to go back to the data due to queries raised in manuscript review. Evidera Ltd are not requesting any new data and use of the data remains for the same purpose/objectives as the original application.

Evidera Ltd utilised existing Cancer Registration data from Public Health England (PHE) to assess the trends in treatment patterns and survival outcomes of patients with kidney cancer (renal cell carcinoma [RCC]) in England, and how the trends vary by stage at diagnosis, disease histology, line of therapy, year of diagnosis and receipt of nephrectomy (surgical removal of the kidney). Specifically, Evidera Ltd analysed the data to describe patient characteristics. Evidera Ltd also calculated a measured called “overall survival”, which is an estimate of the length of time between a defined time point, such as the date of diagnosis of a condition, and the date of death.

The Cancer Registration dataset includes data on demographics, characteristics of the tumour, patients’ vital status and basic information regarding the treatment received. Evidera Ltd utilized the Systemic Anti-Cancer Therapy dataset, which contained information on systemic treatment received by patients in the cancer registry. This was linked to another dataset, Hospital Episode Statistics, which contains information on all hospital visits, admissions and procedures in England.

The following NHS England data will be accessed:

• BAU Hospital Episode Statistics Admitted Patient Care (HESAPC)

• BAU Hospital Episode Statistics Outpatient Patient (HESOP)

• NDRS Cancer Registration

• NDRS Systemic Anti-Cancer Therapy (SACT)

The level of the data will be pseudonymised.

The data will be minimised as follows:

• Limited to patients diagnosed with malignant neoplasm of kidney, except renal pelvis (ICD-10 code: C64x) between 01 April 2014 to 31 December 2018

• Limited to the following geographic areas England

• Limited to patients above the age of 18

Evidera Ltd is the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

Although BMS UK is the research sponsor, BMS UK will not carry out any data controllership activities.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

Evidera have legitimate interest in processing the data as part of a client agreement with BMS to study the treatment and outcomes in patients with renal cell carcinoma.

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.

There is public interest in the processing of this data as it is scientific research regarding treatment and outcomes of patients with renal cell carcinoma in England. Evidera anticipate several potential public health benefits for their analysis. It is necessary to determine any trends in treatment patterns and outcomes in patients with RCC to better understand the evolving treatment landscape in the UK. The dataset contains variables that are not commonly available in UK primary or secondary care data sources, such as cancer stage. This allows for a more granular description of mortality trends within subgroups known to have very different survival experiences. SACT data contain detailed information on cancer treatments received during follow-up. The Cancer Registration data from PHE covers the entire English population, and results are therefore generalisable to the population of England. Evidera have already presented findings at two scientific conferences and are in the process of preparing a manuscript for journal submission.

The funding is provided by BMS UK. The funding is specifically for the study described. Funding is in place until completion of the agreed study. The funder will have no ability to suppress or otherwise limit the publication of findings.

Evidera Ltd is the sole data controller and the data processor.

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

NHS England data have provided the relevant records from the NDRS HESAPC, NDRS HESOP, NDRS SACT and NDRS Cancer Registration datasets to Evidera Ltd. The data contains no direct identifying data items but will contain a unique person ID which can be used to link the datasets together.

The data will not be transferred to any other location.

The data will be stored and backed-up on servers at Evidera Ltd.

The data will be accessed by authorised personnel via remote access . The data will remain on the servers at Evidera Ltd at all times.

Personnel are prohibited from downloading or copying data to local devices.

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

Access is restricted to employees or agents of Evidera Ltd who have authorisation from the Principal Investigator .

BMS UK is not permitted to access the data.

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

The data will not be linked with any other data outside the scope of this agreement.

There will be no requirement and no attempt to reidentify individuals when using the data. As in the previous agreement, Evidera Ltd do not have access to identifiable information such as a patient’s name, NHS number, geographic location or date of birth. This study did not use identifiable personal data. Publications will only summarize aggregate level data void of any personal identifying information. Small numbers will be anonymised.

Analysts from Evidera Ltd will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• An internal report

• Presentations to various conferences in the form of posters in 2023

• Submissions to peer reviewed journals at the end of the study in late 2023

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 relevant recipients through the following dissemination channels:

• Journals

• Posters displayed at ASCO Genitourinary Cancers symposium 2023, and the International Kidney Cancer Symposium, Europe, 2023.

The target dates for submission of the manuscript is by the end of 2023.

Evidera Ltd anticipate several potential public health benefits for the analysis and dissemination. It is necessary to determine any trends in treatment patterns and outcomes in patients with RCC to better understand the evolving treatment landscape in the UK. The dataset previously received contained variables that are not commonly available in UK primary or secondary care data sources, such as cancer stage. This allowed for a more granular description of mortality trends within subgroups known to have very different survival experiences. SACT data contained detailed information on cancer treatments received during follow-up. The cancer registration data from PHE (called PHE at the time of receiving the data) covered the entire English population, and results will therefore be generalisable to the population of England.

The information generated from this study provides insight on characteristics of patients with RCC, and it highlights populations with potentially unmet needs regarding treatment persistence and survival. This information available to healthcare professionals will indirectly impact patient care.

Based on the information published from this study, healthcare professionals will be able to further understand the characteristics of patients with RCC and their treatment patterns using real-world evidence.

Two conference posters containing aggregate results have been presented at ASCO Genitourinary Cancers symposium 2023, and the International Kidney Cancer Symposium, Europe, 2023