Wednesday, 27 August 2014

Another guideline - but this time we're involved!


Guidelines for uniform reporting of body fluid biomarker studies in neurologic disorders. Gnanapavan S, Hegen H, Khalil M, Hemmer B, Franciotta D, Hughes S, Hintzen R, Jeromin A, Havrdova E, Tumani H, Bertolotto A, Comabella M, Frederiksen J, Alvarez-CermeƱo JC, Villar L, Galimberti D, Myhr KM, Dujmovic I, Fazekas F, Ionete C, Menge T, Kuhle J, Keir G, Deisenhammer F, Teunissen C, Giovannoni G.

Neurology. 2014 Aug 22. pii: 10.1212/WNL.0000000000000809. [Epub ahead of print] Review.


ABSTRACT
OBJECTIVE: The aim of these guidelines is to make the process of reporting body fluid biomarker studies in neurologic disorders more uniform and transparent, in line with existing standards for reporting research in other biomedical areas. Although biomarkers have been around for decades, there are concerns over the high attrition rate of promising candidate biomarkers at later phases of development.
METHODS: BioMS-eu consortium, a collaborative network working toward improving the quality of biomarker research in neurologic disorders, discussed the merits of standardizing the reporting of body fluid biomarker research. A checklist of items integrating the results of other published guidances, literature, conferences, regulatory opinion, and personal expertise was created to ultimately form a structured summary guidance incorporating the key features.
RESULTS: The summary guidance is comprised of a 10-point uniform reporting format ranging from introduction, materials and methods, through to results and discussion. Each item is discussed in detail in the guidance report.
CONCLUSIONS: To enhance the future development of body fluid biomarkers, it will be important to standardize the reporting of studies. This guideline by the BioMS-eu consortium is aimed at setting a standard for the reporting of future body fluid biomarker research studies in neurologic disorders. We anticipate that following these guidelines will help to accelerate the selection of biomarkers for clinical development.




Why am I blogging about this on a multiple sclerosis research blog site? Am I right, or am I right?? Lets just say that this paper was a couple of years in the making, as with anything which involves regulation.

Firstly though what is a biomarker? A biomarker is...
"a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention". 

For example, blood pressure is a biomarker, oligoclonal bands is another example; simply anything that can be measured or you can put a value to.

And why?
It is important to standardise biomarker reporting in MS research to make the research that is published a) reliable and b) to allow others to reproduce it. 

What is very annoying is that some prominent names in the MS community still think that there is no reliable marker of disease activity in MS out there (diagnostic or otherwise). And there has never been convincing counter arguments. [What I like to think of as secular stagnation]. Hopefully with standardisation we may get some robust measures which will change the way we think and talk about MS!

CoI: We are authors on this paper

6 comments:

  1. Thank you Neuro Doc Gnanapavan and welcome to the blog

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    Replies
    1. Yes welcome - nice to see another neuro has joined the party :)

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  2. Take heart... there are some prominent people out there that think the worlds flat:-)

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  3. Replies
    1. Hi Neuro Doc G - welcome.

      Keep the news true but positive and don't get upset if people are mean sometimes - they don't do it on purpose.

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