I think that the RWE happens like the Health Technology Assessment: the pyramid of evidence has not been clear enough to put them on a level: the HTAs are Syst review?...they are Systematically derived recommendations?.

The RWE would be at the same level as the Studios. There may be more reliable data from RWE than from a randomized clinical trial, provided that the design and evaluation have the possible confounding factors, limitations, biases, etc.

The announcement of the collaboration to update the definition of the HTA opens the opportunity to review this challenging issue

https://htai.org/blog/2018/08/13/announcement-international-collaboration-to-update-the-definition-of-hta-now-underway/

A recent article, interesting especially from the regulatory perspective

Advancing a Framework for Regulatory Use of Real-World Evidence 

When Real Is Reliable

http://journals.sagepub.com/doi/10.1177/2168479018763591

Regards,
 

Ernesto Barrera Linares 

Family Physician/Médico de Familia

Madrid (Spain)

@ernestob

El sáb., 25 ago. 2018 a las 16:21, Bill Cayley (<[log in to unmask]>) escribió:

At first glance, this simply sounds to me like looking at the difference between effectiveness versus efficacy. In which case, it’s not a matter of where the slides and the evidence hierarchy, but what types of outcomes, what types of patients, and what type of generalizability one is looking at.

Bill Cayley, Jr, MD MDiv  

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A cheerful heart is good medicine...  (Proverbs 17:22)

On Aug 25, 2018, at 4:09 AM, Jon Brassey <[log in to unmask]> wrote:

I am increasingly seeing the term 'real world evidence' and see the FDA are exploring it https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm. It also featured at the HTAi conference in Vancouver. 

I was prompted to post this here after seeing this news story FDA sets out vision to use real-world data in product evaluations. Which led to the recent JAMA article Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.

It got me wondering how does the EBM view this development? How does it fit in with the traditional hierarchies of evidence?

Any thoughts?

Best wishes

jon

--

Jon Brassey

Director, Trip Database

Honorary Fellow at CEBM, University of Oxford

Creator, Rapid-Reviews.info

 

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