RegulatoryScienceData.EU

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Data and tools for regulatory science and research

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All (8)

analyses (1)

code (1)

dataset (5)

documents (1)

procedures (4)

tools (2)

trials (2)

This is a website on personal initiative with resources to support advancing medical research and medicine development. It includes selected content from the https://PaediatricData.EU/ website and blog. Amongst others, websites of the EMA and FDA are acknowledged as original data sources. Users should also acknowledge the sources’ copyright and limited reproduction notices.

Incrementally, further data sources will be added and data sets will be combined for deeper analysis.

Starting cancer medicine trials with children

Analysis of start of trials with children in relation to marketing authorisation for adults

Cancer medicines for children

Manually curated listing of cancer medicines authorised for children

Regulatory documents as Markdown files

Continually updated set of semi-structured data on medicines, development and assessment, to facilitate regulatory science research

Clinical trials analyses: ctrdata, a tool for leveraging register data

A readily-usable tool with a permissive licence for CTIS, EUCTR, CTGOV2 and ISRCTN with examples addressing research questions

PIPs – Paediatric medicines investigations

A searchable webapp showing details of development plans (PIPs), updated at least once a week

Regulatory science, Drug development tools (DDTs)

A list of tools such as biomarkers, simulation approaches, new endpoints, novel methods, commented by regulatory agencies, updated daily

EPARs - European public assessment reports

An interactive webapp with medicine characteristics and assessment reports, updated at least once a week

Inspect data of a clinical trial

Show data structure and search fields and content for any trial that is publicly visible in CTIS, EUCTR, CTGOV2 and ISRCTN

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