NHS Digital Data Release Register - reformatted
Adelphi Real World projects
10 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
A retrospective observational study of treatment patterns, resource use and outcomes in patients with early-stage Non-Small Cell Lung Cancer (NSCLC) in England — DARS-NIC-682583-Z3V2H
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012 s261(2)(a)
Purposes: Yes (Commercial)
Sensitive: Non-Sensitive
When:DSA runs 2023-11-08 — 2025-11-07 2024.05 — 2024.08.
Access method: One-Off
Data-controller type: ADELPHI GROUP LIMITED, MERCK SHARP & DOHME LIMITED (MSD)
Sublicensing allowed: No
Datasets:
- NDRS Cancer Pathway
- NDRS Cancer Registrations
- NDRS Linked Cancer Waiting Times (Treatments only)
- NDRS Linked DIDs
- NDRS Linked HES AE
- NDRS Linked HES APC
- NDRS Linked HES Outpatient
- NDRS National Radiotherapy Dataset (RTDS)
- NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
Expected Benefits:
The data collected within this study is hoped will contribute to the improvement of health and social care planning, as the objectives are hoped will provide:
A better understanding of the clinical characteristics of patients with stage I-III NSCLC
Treatment patterns and observed pathways for patients diagnosed with stage I-III NSCLC
An understanding of gaps in the treatment of stage I-III NSCLC, and highlight where the introduction of immunotherapy and other medical strategies may benefit patient outcomes and improve survival rates.
Lung cancer is the leading cause of cancer mortality with more than 1.7 million deaths worldwide in 2018 (18.4% of total cancer deaths worldwide). It is the third most common cancer in the United Kingdom (UK), with around 48,500 new cases every year. Patients with lung cancer have a poor prognosis; over half of people diagnosed with lung cancer die within one year of diagnosis and the 5-year survival is less than 18%. These statistics highlight that the study results could help highlight gaps in the care of stage I-III NSCLC patients and improve the lives of large proportion of cancer patients in the UK, including the majority of lung cancer patients.
The dissemination strategy is hoped to provide evidence to support clinicians in the treatment of stage I-III NSCLC, inform ongoing standard of care improvement strategies in the use of new and emerging treatments, and appraise the implementation of future clinical trials in line with the overall aim to improve patient outcomes.
The data collected within this study is hoped to contribute to the improvement of health and social care planning, as the objectives will provide an understanding of the burden of stage I-III NSCLC on both patients and the NHS by assessing the real-world effectiveness outcomes (e.g. survival and progression rates), as well as healthcare resource use and costs incurred to the NHS.
Outputs:
The expected outputs of the processing will be:
A report detailing the study rationale, design, methods, aggregated results (in the form of graphs and tables, with small numbers suppressed) and conclusions. This is an internal document that Adelphi Group Limited develop for MSD Medical Affairs UK. The report is used as a basis for manuscript development for submission to peer reviewed journals, as well as abstracts/posters submitted to international conferences.
Submissions to peer reviewed journals.
Posters and abstracts at European Society for Medical Oncology [ESMO] or American Society of Clinical Oncology [ASCO], (to be decided).
The target date for dissemination of the first draft internal study report is 5 months post-receipt of the data, after which publication will be considered where time scales are likely to be 12 months post receipt of data.
The outputs will not contain NHS England data and will only contain aggregated data with small number suppression applied where as appropriate, in line with the relevant disclosure rules for the datasets from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
Journals
Conferences
The study is not looking at specific treatments and direct outcomes and no safety data will be generated as a result of this study.
Processing:
No data will flow to NHS England for the purposes of this Agreement.
NHS England data will provide the relevant records from the NDRS HESAPC, NDRS HESAE, NDRS HESOP, NDRS DID, NDRS CWT, NDRS SACT, NDRS RTDS, NDRS Cancer Registry and NDRS Cancer Pathway datasets to Adelphi Group Limited. The data will contain no direct identifying data items but will contain a unique person ID.
The data will not be transferred to any other location.
Data will be securely stored on a UK-based cloud facility named Box.com ltd. Box.com ltd staff do not have access to NHS England data. Access to the study file is restricted to only the immediate project team. Access is restricted by Adelphi Group Limiteds central IT services department whereby a request must be submitted and authorised through a chain of command, upon receipt of a detailed, valid rationale e.g. onboarding of an additional member of the study team. Access will only be granted for the purposes described in this application.
The data will be accessed by authorised personnel via remote access. The data will be stored on the servers at Box.com ltd at all times.
- 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 agreement) and complies with the organisations remote access policy.
The data will not leave England/Wales at any time.
Only substantive employees of Adelphi Group Limited who have received appropriate training in data protection and confidentiality will have access to and process the data. All employees of Adelphi Group Limited are contractually obliged to remain current with data protection and confidentiality training.
MSD Medical Affairs UK and other subsidiaries that fall under Adelphi Group Limited are not permitted to access or view any data released under this Agreement that is not aggregated with small numbers suppressed.
Box.com Ltd provides IT support and hosting services to Adelphi Group Limited. They supply support to the system but do not access data.
The data will not be linked with any other data outside of the scope of the agreement.
Confidentiality of information on study subjects is maintained by the provision of de-identified patient-level data where patients are identified by a unique identifier only. There is no requirement to re-identify individuals from the de-personalised data disseminated in this agreement.
Analysts from Adelphi Group Limited will only analyse the data for the purposes described above.