Key Topic 2 – Subtopic 2: Abstracts, reviews and real world evidence
Abstracts
Local regulations vary on whether abstracts can be used to support claims, as they are not subject to the same level of peer review as full published papers.
If you are considering use of an abstract to support a claim it’s worth remembering that preliminary results may not be enough to support it. The nature of the data should be made clear.
Review articles
These may be used to support a claim but it is preferable to cite the original publications if possible.
You should check that the review article has accurately reflected the original data and represents an up to date view of all of the evidence.
These may be used to support a claim but it is preferable to cite the original publications if possible. You should check that the review article has accurately reflected the original data and represents an up to date view of all of the evidence.The rules governing the use of ‘real world’ evidence as the basis of any product claims or statements vary from country to country.
Real World Evidence
Only robust, well conducted real world studies should be used as a basis for statements.
It should be made very clear that the data are from a real world study (footnotes are not adequate for this).
When describing findings no definitive statement or claim of effect should be made.
Instead you should describe associations e.g ‘In a real world study using observational data from patients electronic health records, product X was associated with a reduced annual rate of COPD exacerbations compared to product Y.
In addition it should not be stated that such studies ‘showed’ an effect, but rather it ‘provides further evidence of ..’ or ‘is supportive of…’
