Notes to File: Golden Rules and Red Flags
The Real-World Evidence Study Master File Team has received feedback that Notes to File (file notes) are not listed in the artefacts on the RWE SMF Index. When creating the RWE SMF, the team deliberately [...]
MHRA Draft Guidance on Randomised Controlled Trials Generating Real-World Evidence to Support Regulatory Decisions
The MHRA have drafted new guidance providing points to consider when planning a randomised clinical trial using real world data, with the intention of submitting this trial to gain a regulatory approval - such as [...]
ITALY – Increasing Need for a New Legislation to Facilitate Execution of Observational Studies
In the last decade scientists conducting observational studies in Italy faced several obstacles, mostly caused by ambiguous terminology and definitions, and by a national legislation that need to be updated. This has been causing not [...]
France’s Health Data Hub to Move to European Cloud Infrastructure to Avoid EU-US Data Transfers
France’s data regulator CNIL has issued some recommendations for French services that handle health data, as Mediapart first reported. Those services should avoid using American cloud hosting companies altogether, such as Microsoft Azure, Amazon Web Services [...]
Real World Data (RWD) in Times of Change
The impact of COVID-19 is a black swan event or “an event that happens so rarely that it is incredibly hard to predict and even harder to prepare for.” However, we must be prepared. The [...]
FDA Launches the Digital Health Center of Excellence
Recently, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence [...]
Revision 3 of GVP Module VIII (EMA)
Revision 3 of GVP Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies The revisions to GVP Module VIII are as follows: In section VIII. Add.I.2., [...]
Real World Evidence: From Activity to Impact in Healthcare Decision Making
Real-world evidence could significantly improve healthcare decisions across the health system and ultimately improve patient care. Expanding its use, however, will require multi-stakeholder action on several priorities, as well as company-specific campaigns. The broad healthcare [...]
Eighth Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published
The 8th revision of the ENCePP Methods Guide has been published on the ENCePP website. This latest version includes revisions, amendments and new references in most of the chapters. Revisions were performed by the authors in [...]
Announcing the Real World Study Document Index (RWS-DI)
Why is a stand alone index needed? Those of you who are involved in real world studies (RWS) know that trying to file your documents using the existing TMF Reference Model (TMF RM) based on [...]
Pharma’s Investment In RWE Is Beginning To Pay Off
Companies that have invested in mature RWE capabilities are seeing returns; others are behind. Results from Deloitte’s third RWE benchmarking study reveal how companies still building their capabilities can catch up: 94% of survey respondents [...]
EMA Calls for High-Quality Observational Research in Context of COVID-19
For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, and collaboration between researchers, to ensure high-quality, powerful studies. High-quality observational research of real world data collected during [...]