Triple Negative Breast Cancer Study
Methods Business and Digital Technology Limited · Supplier (IT)
In term In term in the September 2026 edition: the latest version runs to 13 December 2026.
- Reference
- DARS-NIC-744993-Z8K2K
- Current version
- v2.2
- Term of current version
- 5 June 2026 to 13 December 2026
- Start date
- 17 December 2024
- Data controller
- Sole Data Controller
- Commercial purposes
- Yes
- Sublicensing
- No
- Files released to date
- 0
Why the data was released
Objective for processing
Methods Business and Digital Technology Limited 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 Methods Business and Digital Technology Limited:
Methods Business and Digital Technology Limited 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 Business and Digital Technology 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 Business and Digital Technology Limited 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 Business and Digital Technology Limited 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 Business and Digital Technology Limited.
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 Business and Digital Technology Limited 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 Business and Digital Technology Limited 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 Business and Digital Technology Limited 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.
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, advice was sought form 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 Business and Digital Technology Limited with the task of obtaining data and analytical efforts. Methods Business and Digital Technology Limited 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 Business and Digital Technology Limited 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.
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. 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 Business and Digital Technology 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.
While the findings may have broader relevance to stakeholders, including the funder, the study is not designed to evaluate or promote any specific commercial product and the primary purpose is public benefit and all outputs will be disseminated openly regardless of outcome.
Processing activities
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 Business and Digital Technology Limited. 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 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).
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 Business and Digital Technology Limited 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 Business and Digital Technology Limited will analyse the Data for the purposes described above.
Expected output
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 late 2026. 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 late 2026.
Expected measurable 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 Business and Digital Technology Limited 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 Business and Digital Technology Limited 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 Business and Digital Technology Limited will be seeking to present the findings at medical conferences to further disseminate the findings to the medical community.
Additionally, Methods Business and Digital Technology Limited 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 study’s credibility and its potential to influence future cancer treatment strategies.
Benefits reported so far
Not stated in the register.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(a)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| NDRS Cancer Consolidated Data Set | Anonymised - ICO Code Compliant | Non-Sensitive | System Access | Does not include the flow of confidential data |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-744993-Z8K2K-v2.2 5 June 2026 to 13 December 2026
- Title
- Triple Negative Breast Cancer Study
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 1
- Files released
- 0
Datasets: NDRS Cancer Consolidated Data Set
What changed from DARS-NIC-744993-Z8K2K-v1.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Applicant organisation | METHODS BUSINESS AND DIGITAL TECHNOLOGY LIMITED | |
| Organisation type | Supplier (IT) | |
| Start date | 2026-06-05 |
Data controllers:
+ METHODS BUSINESS AND DIGITAL TECHNOLOGY LIMITED · − METHODS ANALYTICS LTD
Objective for processing
Method Analytics Ltd
Methods Business and Digital Technology Limited
requires access to NHS England data for the purpose of the following research project:
"Triple Negative Breast Cancer Study"
Triple Negative Breast Cancer Study
The following is a summary of the aims of the research project provided by Methods Business and Digital Technology Limited:
The following is a summary of the aims of the research project provided by Method Analytics Ltd:
Methods Business and Digital Technology Limited 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:
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:
[19 paragraphs unchanged]
This research aims to address critical disparities in TNBC treatment outcomes and
[30 words unchanged]
using routinely collected data sources insufficient for TNBC. Data Scientists from Methods
Analytics
Business and Digital Technology
will also access the data for the purpose of conducting benchmarking, detecting
[20 words unchanged]
for benchmarking, detecting variation, and facilitating informed comparisons to drive improvement initiatives.
[9 paragraphs unchanged]
Methods
Analytics Ltd
Business and Digital Technology Limited
is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
[1 paragraph unchanged]
Gilead Science Ltd has commissioned Methods
Analytics
Business and Digital Technology Limited
to undertake the work. Gilead Science Ltd does not specify what data
[11 words unchanged]
be processed to achieve that purpose. Such decisions are taken by Methods
Analytics.
Business and Digital Technology Limited.
[2 paragraphs unchanged]
Methods
Analytics Ltd
Business and Digital Technology Limited
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
Business and Digital Technology Limited
is a commercial company which provides services for profit.
[2 paragraphs unchanged]
This processing is in the public interest because the research is focused
[31 words unchanged]
language with treatments received and patient outcomes. By conducting this study, Methods
Analytics
Business and Digital Technology Limited
aim to generate valuable insights that will directly contribute to improving treatment
[14 words unchanged]
better patient care, offering hope to those affected by this challenging disease.
[2 paragraphs unchanged]
Microsoft Limited provides IT hosting services to Methods Analytics and will store the Data as contracted by Methods Analytics.
[1 paragraph unchanged]
As part of the scoping and feasibility work,
Methods Analytics Ltd worked with
advice was sought form
medical professionals from Clatterbridge Hospital, University Hospitals Sussex NHS Foundation Trust, Nottingham
[13 words unchanged]
Hospitals Leicester to help design the research question and areas of focus.
[1 paragraph unchanged]
Gilead Science charge Methods
Analytics
Business and Digital Technology Limited
with the task of obtaining data and analytical efforts. Methods
Analytics
Business and Digital Technology Limited
receives funding from Gilead Science for the effort involved in obtaining the data and undertaking the analytical efforts.
[2 paragraphs unchanged]
All of Methods
Analytics
Business and Digital Technology Limited
work using NHS England data assets, whether with the NHS or non-NHS
[35 words unchanged]
in England, so that care can be more efficient and higher quality.
While there is a small commercial component to this request, the
The
primary objective of the research is to advance public health and improve
[14 words unchanged]
Gilead Science, which has provided the necessary resources to create this paper.
However, the
The
involvement of the funder is strictly limited to financial support and does not influence the study's design, analysis, or outcomes.
[2 paragraphs unchanged]
Gilead Science produced a drug (Trodelvy) used to treat TNBC. Methods
analytics
Business and Digital Technology
will receive data from the years when this drug was introduced to the market.
[5 paragraphs unchanged]
While the findings may have broader relevance to stakeholders, including the funder, the study is not designed to evaluate or promote any specific commercial product and the primary purpose is public benefit and all outputs will be disseminated openly regardless of outcome.
Processing activities
[2 paragraphs unchanged]
NHS England will provide access to the relevant records from the NDRS Data to Methods
Analytics Ltd.
Business and Digital Technology Limited.
The Data will:
[17 paragraphs unchanged]
Access is restricted to employees of Methods
Analytics Ltd
Business and Digital Technology Limited
who have authorisation from the Project Lead.
[3 paragraphs unchanged]
Researchers from Methods
Analytics Ltd
Business and Digital Technology Limited
will analyse the Data for the purposes described above.
Expected output
[1 paragraph unchanged]
> Submissions to peer reviewed journals such as Clinical Oncology, Value in Health, and the British Journal of Oncology, expected
early 2025.
late 2026.
These papers will be shared with Gilead, and the national GIRFT team lead
[5 paragraphs unchanged]
Outputs are expected to be produced by
early 2025.
late 2026.
Expected measurable benefits
[8 paragraphs unchanged] Access to the broader breast cancer data is essential for improving Methods Business and Digital Technology Limited understanding of any sociodemographic and clinical factors potentially influencing TNBC outcomes. TNBC [53 words unchanged] a direct comparison cohort as opposed to input variables from other research. [1 paragraph unchanged] Whilst it is not possible to predict the outcomes of the study and the full benefits this paper will have to patients, Methods Business and Digital Technology Limited believe this process will enhance diagnostic approaches to TNBC, improve patient outcomes [50 words unchanged] they receive the best possible care and support throughout their treatment journey. [1 paragraph unchanged] The primary goal is to maximise the public benefits from this research [46 words unchanged] patients and the broader health and social care system. In addition, Methods Business and Digital Technology Limited will be seeking to present the findings at medical conferences to further disseminate the findings to the medical community. Additionally, Methods Business and Digital Technology Limited have been in contact with consultants in oncology and are actively exploring [34 words unchanged] the study’s credibility and its potential to influence future cancer treatment strategies.
Benefits reported
Stated in the previous version and removed here.
Analysis outputs are yet to be finalised and so published.
DARS-NIC-744993-Z8K2K-v1.3 14 November 2025 to 13 December 2026
- Title
- Triple Negative Breast Cancer Study
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 1
- Files released
- 0
Datasets: NDRS Cancer Consolidated Data Set
What changed from DARS-NIC-744993-Z8K2K-v0.8
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-11-14 | |
| End date | 2026-12-13 |
Benefits reported
Yielded Benefits is not a requirement for new applications.
Analysis outputs are yet to be finalised and so published.
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
Objective for processing
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 output
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.
Benefits reported
Analysis outputs are yet to be finalised and so published.
DARS-NIC-744993-Z8K2K-v0.8 17 December 2024 to 16 December 2025
- Title
- Triple Negative Breast Cancer Study
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 1
- Files released
- 0
Datasets: NDRS Cancer Consolidated Data Set
Objective for processing
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 output
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.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
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February 2025 —
first listed. 1 version: DARS-NIC-744993-Z8K2K-v0.8
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January 2026
1 version added: DARS-NIC-744993-Z8K2K-v1.3
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July 2026
1 version added: DARS-NIC-744993-Z8K2K-v2.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-744993-Z8K2K, “Triple Negative Breast Cancer Study”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-744993-z8k2k/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-744993-Z8K2K to see the original rows.