Good TREs work

Methods Analytics Ltd projects

Triple Negative Breast Cancer Study (partially via "system access")
Standard Extract Subscription - Renewal

1625 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Methods Analytics Ltd was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Methods Analytics Ltd may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Triple Negative Breast Cancer Study — DARS-NIC-744993-Z8K2K

Opt outs honoured: unknown (Excuses: Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 s261(2)(a)

Purposes: Yes (Supplier)

Sensitive: Non-Sensitive

When:DSA runs 2024-12 – 2025-12 2025.01 — 2025.01. breached contract — audit report.

Access method: System Access
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)

Data-controller type: METHODS ANALYTICS LTD

Sublicensing allowed: No

Datasets:

NDRS Cancer Consolidated Data Set

Type of data: Anonymised - ICO Code Compliant (note: this information not disclosed for TRE projects )

Objectives:

Method Analytics Ltd requires access to NHS England data for the purpose of the following research project:
Triple Negative Breast Cancer Study

The following is a summary of the aims of the research project provided by Method Analytics Ltd:

Methods Analytics requires access to NHS England data to describe and characterise the Real World treatment of TNBC breast cancer (both early and metastatic) in multiple centres in England. In particular, the associations of deprivation status and ethnicity with the following will be investigated:

a. Treatments received:
i. Chemotherapy

1. Timing (Adjuvant / neoadjuvant)

2. Regimens
ii. Use of PARP inhibitors
iii. Surgery
iv. Radiotherapy
v. Referral to cancer genetics (if meets age criteria)

Adjustment will be made for other potentially confounding factors including:

a. Other patient characteristics:
vi. Performance status
vii. Co-morbidities
viii. Body mass Index
ix. Age

b. Tumour Characteristics:
i. Tumour size
ii. Nodal involvement
iii. Grade
iv. Inflammatory breast cancer

This research aims to address critical disparities in TNBC treatment outcomes and access, ensuring the findings contribute valuable insights to the medical community. This study is particularly crucial as ICD-10 classifies breast cancer by site rather than phenotype, making standard analytics approaches using routinely collected data sources insufficient for TNBC. Data Scientists from Methods Analytics will also access the data for the purpose of conducting benchmarking, detecting variation, and facilitating informed comparisons. The processing activities are proportionate to the intended purpose, as national healthcare data is essential for benchmarking, detecting variation, and facilitating informed comparisons to drive improvement initiatives.

The following NHS England Data will be accessed:
> NDRS Cancer Consolidated Data Set - necessary to understand patients outcomes and treatments for TNBC.

The level of the Data will be:
> Pseudonymised

The Data will be minimised as follows:
> Limited to patients who have been diagnosed with Breast cancer, ICD-10 codes: C50, D05
> Limited to data between 1st January 2016 to latest available
> Data is required for all of England.

Understanding TNBC in contrast to non-TNBC is an essential part of characterisation of the disease and ensures the study will have significant additional value given the greater insight this will provide. Utilising the wider breast cancer dataset to provide these comparisons will be the most robust approach and minimise issues arising from differing analysis techniques or cohort construction.

Methods Analytics Ltd is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

Although Gilead Science Ltd is the research sponsor, Gilead Science Ltd will not carry out any controllership activities.

Gilead Science Ltd has commissioned Methods Analytics to undertake the work. Gilead Science Ltd does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by Methods Analytics.

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.

Methods Analytics Ltd has determined the processing is necessary for its legitimate interests in providing healthcare data analytics services to help NHS and private sector healthcare providers. Methods Analytics Ltd is a commercial company which provides services for profit.

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.

This processing is in the public interest because the research is focused on addressing significant gaps in the understanding of Triple Negative Breast Cancer, an area that has historically seen poor patient outcomes and limited research specifically investigating deprivation status, ethnicity and primary language with treatments received and patient outcomes. By conducting this study, Methods Analytics aim to generate valuable insights that will directly contribute to improving treatment strategies and healthcare practices within the NHS. The findings are expected to lead to better patient care, offering hope to those affected by this challenging disease.

The funding is provided by Gilead Science Ltd. The funding is specifically for the study described.

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

Microsoft Limited provides IT hosting services to Methods Analytics and will store the Data as contracted by Methods Analytics.

A healthcare subject matter expert will be advising on the structure and format of the research paper but will not have access to the NHSE secure data platform.

As part of the scoping and feasibility work, Methods Analytics Ltd worked with medical professionals from Clatterbridge Hospital, University Hospitals Sussex NHS Foundation Trust, Nottingham City Hospital, Royal Free Hospital, Southampton General Hospital, University Hospitals Birmingham and University Hospitals Leicester to help design the research question and areas of focus.

Commercial element:

Gilead Science charge Methods Analytics with the task of obtaining data and analytical efforts. Methods Analytics receives funding from Gilead Science for the effort involved in obtaining the data and undertaking the analytical efforts.

Gilead Science may receive, review and assess the quality of outputs produced. Gilead Science will not direct the methodology of the work or comment/contribute to the analytical findings.

Gilead Science will not block publication on the grounds of the analytical outputs.

All of Methods Analytics work using NHS England data assets, whether with the NHS or non-NHS bodies supporting the NHS, is undertaken with a view to putting into the hands of decision makers and/or the public domain meaningful intelligence to enable people who directly or indirectly provide care to the population in England, so that care can be more efficient and higher quality.

While there is a small commercial component to this request, the primary objective of the research is to advance public health and improve outcomes for patients with Triple Negative Breast Cancer. The study is funded by a Gilead Science, which has provided the necessary resources to create this paper. However, the involvement of the funder is strictly limited to financial support and does not influence the study's design, analysis, or outcomes.

Nature of the Commercial Interest:
The funding received from the Gilead Science is specifically allocated for conducting the research and for the submission of the resulting paper to medical journals. The Gilead Science will not have access to the data itself, nor will they derive direct commercial benefit from the findings.

Gilead Science produced a drug (Trodelvy) used to treat TNBC. Methods analytics will receive data from the years when this drug was introduced to the market.

Demonstration of Public Benefit:
The research aims to fill critical gaps in understanding the progression, treatment efficacy, and patient outcomes for Triple Negative Breast Cancer, an area with disproportionately poor outcomes and limited existing research. The insights gained from this study have the potential to:
Improve Patient Outcomes: By identifying factors that contribute to the poor prognosis, this research could inform the development of more effective treatment strategies, ultimately benefiting patients within the NHS and beyond.
Enhance Healthcare Practices: The study's findings will be disseminated, contributing to the broader medical community's knowledge and potentially influencing future clinical guidelines and healthcare policies.
Support the NHS in Research and Innovation: The results will support ongoing efforts within the NHS to innovate and improve care for cancer patients, aligning with the broader goals of the Health and Social Care Act 2012.

Expected Benefits:

The findings of this research study are expected to further the understanding of TNBC and to facilitate improvements to care of patients with TNBC.

The use of the data could:
> help the system to better understand the health and care needs of populations.
> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
> advance understanding of regional and national trends in health and social care needs.
> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
> inform decisions on how to effectively allocate and evaluate funding according to health needs.

It is hoped that through media publication(s) of findings, the findings of this research will add to the body of evidence that is considered by organisations and individual care practitioners charged with making policy decisions or decisions on treatment for or within the NHS. It is also hoped that this research will add to the real-world evidence available to understand the variation according to ethnicity and/ or social deprivation.

Access to the broader breast cancer data is essential for improving Methods understanding of any sociodemographic and clinical factors potentially influencing TNBC outcomes. TNBC disproportionately affects certain populations and often correlates with socioeconomic challenges, yet the existing research and comparison pools remain limited. By examining TNBC within the context of the broader breast cancer dataset, we can begin to uncover trends and disparities that would otherwise remain hidden. The value of this is particularly enhanced by having a direct comparison cohort as opposed to input variables from other research.

This broader dataset enables meaningful comparisons, identifying both shared and distinct patterns among TNBC cases and other breast cancer subtypes. While not providing direct solutions, these insights will help to refine hypotheses and inform more targeted research approaches. In particular, understanding how deprivation and ethnicity intersect with TNBC outcomes could guide future studies into tailored therapeutic strategies and interventions. Over time, this could support incremental advancements in care quality and accessibility, especially for communities most affected by disparities in TNBC outcomes.

Whilst it is not possible to predict the outcomes of the study and the full benefits this paper will have to patients, Methods believe this process will enhance diagnostic approaches to TNBC, improve patient outcomes and inform updates to current policies. Understanding the variation according to ethnicity and/ or social deprivation will ensure all patients can expect the same treatment and outcome. By addressing these key areas, the paper has the potential to make a significant and positive impact on the lives of patients, ensuring they receive the best possible care and support throughout their treatment journey.

In summary, this research aims to address critical gaps in understanding and treating TNBC, with the primary goal of advancing public health and improving patient outcomes. By analysing data and publishing the findings in a reputable medical journal, the intention is to disseminate valuable insights that can enhance treatment strategies and patient care practices.

The primary goal is to maximise the public benefits from this research by advancing the understanding and treatment of TNBC. The findings will be published in a reputable medical journal, ensuring that they reach a wide audience of healthcare professionals, researchers, and policymakers. This will facilitate the integration of insights into clinical practices and healthcare policies, ultimately benefiting patients and the broader health and social care system. In addition, Methods will be seeking to present the findings at medical conferences to further disseminate the findings to the medical community.

Additionally, Methods have been in contact with consultants in oncology and are actively exploring opportunities to collaborate with them as co-authors on the study. Their expertise will be invaluable in interpreting the data and ensuring that the findings are both accurate and impactful. This collaboration will further enhance the studys credibility and its potential to influence future cancer treatment strategies.

Outputs:

The expected outputs of the processing will be:
> Submissions to peer reviewed journals such as Clinical Oncology, Value in Health, and the British Journal of Oncology, expected early 2025. These papers will be shared with Gilead, and the national GIRFT team lead
> Presentations at appropriate conferences, such as the UK Oncology Nursing Society Conference and the European Society for Medical Oncology Breast Cancer Conference

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
> Conferences

Outputs are expected to be produced by early 2025.

Processing:

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

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry-leading analytics tools.

NHS England will provide access to the relevant records from the NDRS Data to Methods Analytics Ltd. The Data will:
Contain special categories of personal data but with no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be stored on servers at NHS England.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and 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 organisations DSPT (or other security arrangements as per this DSA) and complies with the organisations 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).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees of Methods Analytics Ltd who have authorisation from the Project Lead.

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.

Researchers from Methods Analytics Ltd will analyse the Data for the purposes described above.

Standard Extract Subscription - Renewal — DARS-NIC-09519-D5G0R

Opt outs honoured: N, Y, No - data flow is not identifiable, No (Excuses: Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 s261(2)(b)(ii)

Purposes: Yes (Supplier)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2019-12 – 2020-12 2017.06 — 2022.12. breached contract — audit report.

Access method: Ongoing, One-Off