RWR Insights | What’s in a name? The humble (confusing) non-interventional study and the anti-definition

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The-Evidence-Base-RWE-Terminology-March-2024

RWR CONTEXT

The FDA definition for non-interventional studies is intuitively actionable. We, as researchers, can (confidently) classify our study based on the parameters provided, which in turn allows us to identify the applicable regulations and guidelines and build our study playbook to describe what we need to do (regulatory requirements) and what we should consider (regulatory considerations) depending on the intended use of the RWE we generate.

4 MARCH 2024 – In his latest Guest Column, Stuart McCully (Real-World Research Ltd) discusses the differing definitions of non-interventional studies in Europe and the US, and the need for clarity when discussing these studies in real-world evidence (RWE) generation.

Read the full article HERE.

USA – FDA Approves New Use of Transplant Drug Based on Real-World Evidence
Gallery
USA – FDA Approves New Use of Transplant Drug Based on Real-World Evidence

2021, July 2021, Members-Only, Minor Update, USA

RWR CONTEXT A tangible example of how real world evidence (RWE) can be used to support label extensions for existing drugs. Note the FDA’s emphasis on: “This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data [...]

UK – NHS Digital (NHSD) has Paused the Roll-Out of the General Practice Data for Planning and Research (GPDPR)
Gallery
UK – NHS Digital (NHSD) has Paused the Roll-Out of the General Practice Data for Planning and Research (GPDPR)

2021, Data Privacy and Data Protection, July 2021, Members-Only, Minor Update, UK

RWR CONTEXT At first glance, the General Practice Data for Planning and Research (GPDPR) seems innocuous. The UK’s NHS is making GP patient data available for research purposes. What isn’t made clear, is that this is an ‘opt out’ [...]

Germany – Relaunch of the BfArM Website
Gallery
Germany – Relaunch of the BfArM Website

2021, Germany, July 2021, Members-Only, Minor Update

RWR CONTEXT This major revision to the BfArM website is likely to have impacted any (all) links to their website created before 1 July 2021. Recommend you check and update hyperlinks to the new BfArM website. 1 [...]

EU – 9th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published
Gallery
EU – 9th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published

2021, ENCePP, EU, July 2021, Members-Only, Minor Update

RWR CONTEXT The EMA references this standard in the context of non-interventional post-authorisation safety studies (PASS) as: “Relevant scientific guidance should be considered [= Recommendation, not a legal mandate] by marketing authorisation holders and investigators for the development of [...]

Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devices
Gallery
Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devices

2021, Denmark, July 2021, MDR, Medical Devices, Members-Only, Significant Update

RWR CONTEXT This is a complete refresh of the guidance for applying for permits for clinical trials of medical devices and also covers the requirements for post approval studies of medical devices. Note that Guide no. 9761 of 10 [...]

France – Update to the CPP (Research Ethics Committee) Information
Gallery
France – Update to the CPP (Research Ethics Committee) Information

2021, France, July 2021, Members-Only, Significant Update

RWR CONTEXT We’re revisiting this change in case you missed it. The CN RIPH system has been replaced with the CPP Information System (SI RIPH 2G), which means you will need to replace any mentions of (and hyperlinks to) [...]