Guidelines for uniform reporting of body fluid biomarker studies in neurologic disorders

1. Sharmilee Gnanapavan, MD, PhD, 
2. Harald Hegen, MD, PhD, 
3. Michael Khalil, MD, PhD, 
4. Bernhard Hemmer, MD, PhD,
5. Diego Franciotta, MD, 
6. Steve Hughes, MD, 
7. Rogier Hintzen, MD, PhD, 
8. Andreas Jeromin, PhD, 
9. Eva Havrdova, MD, PhD, 
10. Hayrettin Tumani, MD, PhD, 
11. Antonio Bertolotto, MD, PhD, 
12. Manuel Comabella, MD, 
13. Jette Frederiksen, MD, DMSc, 
14. José C. Álvarez-Cermeño, MD, PhD, 
15. Luisa Villar, PhD, 
16. Daniela Galimberti, MD, PhD, 
17. Kjell-Morten Myhr, MD, PhD, 
18. Irena Dujmovic, MD, PhD, 
19. Franz Fazekas, MD, 
20. Carolina Ionete, MD, PhD, 
21. Til Menge, MD, PhD, 
22. Geoffrey Keir, PhD, 
23. Florian Deisenhammer, MD, MSc, 
24. Charlotte Teunissen, PhD and 
25. Gavin Giovannoni, MBBCh, PhD

1. Published online before print August 22, 2014Neurology 

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.