Using Review articles from Pubmed for CER

During the search in pubmed for the CER , are there any guidelines or rules to be followed? My search results provides me many REVIEW articles on the topic along with clinical studies. Are these review articles allowed to be used to justify the product GSPR or clinical benefit?
 

monoj mon

Trusted Information Resource
So far I am not aware of such prohibition on type of articles. Ultimately you will need to determine the relevance, quality and scientific validity of the article in order to include it in your CER. Often I find that a randomized study conclude cautiously citing sample size as a limitation. Whereas, sometime a well constructed review article provides a better picture regarding several unanswered question.
 
I agree that review articles provide a better picture. Its good to know there is no such rule. The challenge I am facing in using it is, since these articles are usually referencing many studies out there.. would it be considered as a duplication of data in my report?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I see no reason not to. In your CE Plan document where you are sourcing the studies and what criteria you are using to include or exclude. Make sure to note any pivotal study data.

This is from our SOP

  • Clinical Evaluations Stages
  • Clinical Evaluations are performed based on comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the affected device including clinical performance data and clinical safety data.
  • Clinical Evaluations are performed in four main stages:
  • Stage 0: Define the scope, plan the clinical evaluation (also referred to as scoping and the clinical evaluation plan).
  • Stage 1: Identify pertinent data
  • Stage 2: Appraise each individual data set, in terms of its scientific validity, relevance and weighting.
  • Stage 3: Analyze the data, whereby conclusions are reached about:
  • Compliance with Essential Requirements on performance and safety of the device, including its benefit/risk profile,
  • The contents of information materials supplied by the manufacturer (including the label, IFU of the device, available promotional materials, including accompanying documents possibly foreseen by the manufacturer),
  • Residual risks and uncertainties or unanswered questions (including on rare complications, long term performance, safety under wide-spread use), whether these are acceptable for CE-marking, and whether they are required to be addressed during PMS.
  • Stage 4: Finalize the clinical evaluation report

 

Raisin picker

Quite Involved in Discussions
There are reviews and reviews. In my field, I often come on "reviews" talking about some chosen publications/investigations. They are not worth mentioning (maybe you can find one or two leads in the references). Systematic reviews are very useful. Again, you have to analyse the review criteria similar to analysing the criteria in a single investigation. With luck, you find one at Chochrane, or some HTA.
And of course, take care about duplicate data. I have seen trials that have published interim reports on a yearly basis, "review" articles comparing to one or two other trials, and analyses of aspects not originally included in the trial. You have to consolidate that, drop all interim reports but the last (or final) report, explain what data you take from the "other aspects articles".
You find industrious scientists/practitioners that publish a case series of 40 patients from 2007 to 2010, and another one of 100 patients from 2008 to 2015, and a third one on 150 patients from 2012 to 2018. Maybe including several/different generations of the device, containing duplicate patients. They usually forget to include data to exactly identify the overlap.
 
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