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Data Driven Evaluation of Off Label Neonatal Drug Treatments

Safe People

Organisation name

Strategic Intelligence Alliance in Healthcare Ltd

Applicant name(s)

Stuart BoyceDavid TwinberrowPaul RemingtonMax Wheel

Funders/ Sponsors

Aspire Pharma LtdImperial College, London

DEA accredited researcher?

No

Safe Projects

Project ID

6250-06CD-D814-3F98-5124-4936

Lay summary

To examine and analyse the use of off label/off licence medicines in neo natal care. This study will quantify the number and proportion of medicines used in neonatal care that are off licence/off label. It will mine the data to obtain insights into the use of these medicines to help identify opportunities to develop licenced treatments. Data Required The data needed for the study can be obtained from the NNRD, because this study is solely looking at the use of medicines in neonatal care. Data Access As this study only needs information about treatments and conditions and there is no need for anonymised longitudinal data. It would seem that this would be an ideal way to ‘prove’ the accessibility of data using a Level 1 Engagement i.e., the provision of a data extract. The SIA will liaise with the NNRD Data Analysis Unit to agree the specification for the data extract. Any additional agreed extract specification if required, would then be requested via the DARS (Data Access Request Service, via NHSD). The NNRD request will then be forwarded to Imperial, the data custodian.

Public benefit statement

1. It adresses unmet needs for neonatal drugs and dosage. 2. Improve outcomes in neonatal care 3. Provide a basis for further and future use of the NNRD by commercial bodies to develop new and repurposed treatments 4. To assist NHS neonatal units and NHS special commissioning teams

Latest approval date

09/03/2023

Safe Data

Dataset(s) name
Legal basis for provision of data under Article 6

Not applicable

Lawful conditions for provision of data under Article 9

Not applicable

Common Law Duty of Confidentiality

Not applicable

Request frequency

One-off

Safe Setting

Access type

Release

How has data been processed to enhance privacy?

Not applicable No Personal data will be used