Arising from a 2019 Report of the NANDS Council Working Group for ME/CFS Research (NANDS – the National Advisory Neurological Disorders and Stroke) NANDS announced (in 2022) the development of a Research Roadmap process for ME/CFS, to identify research priorities centred on moving ME/CFS research towards translational studies and clinical trials.
The finalised Roadmap was informed by a new working group, including ME/CFS basic and clinical experts from the research community, leaders of ME/CFS non-profit advocacy and research organisations, as well as people with lived experience of teh disease (i.e., individuals with ME/CFS, those with a family history of ME/CFS, caregivers/care partners, and/or patient advocates). The Working Group met regularly in 2023 and 2024 to discuss and develop the Roadmap and, on 15th May 2024, the Report of the ME/CFS Research Roadmap Working Group of Council was published.
The 59 page document lays out the need for transformative change in ME/CFS research as “the causes and biological mechanism(s) remain unknown, there is no laboratory diagnostic test, and no FDA-approved treatment for ME/CFS. Exact numbers are unknown, but it is estimated that between 836,000 to 2.5 million people in the United States have ME/CFS and direct and indirect economic costs associated with the disease may range from $18 billion to $51 billion annually in the U.S.”
In summary, the Report lays out 27 specific gaps in ME/CFS knowledge/research followed by strategies to defeat these. Each gap identifies an important area but, in particular, the following are identified and mitigating strategies recommended –
- Devising an overarching research strategy to address the complex nature of ME/CFS
- Promoting increased awareness in the medical and scientific community
- Reducing disease stigma by promoting the importance and value of research on ME/CFS
- Increasing the number of ME/CFS research grant applications submitted to NIH
- Promoting a more multidisciplinary and collaborative approach to the study of ME/CFS
- Expanding the number of new researchers and early career investigators entering the ME/CFS field
- Using case definitions that facilitate broader research utility and data sharing
- Building consensus on inclusion/exclusion criteria for control groups in ME/CFS research
- Increasing understanding of different stages of ME/CFS
- Addressing the heterogeneous and multifactorial nature of ME/CFS
- Addressing heterogeneity within individuals with ME/CFS
- Increasing knowledge about disease subtypes
- Addressing barriers to ME/CFS clinical trials
- Deciphering the underlying mechanisms specific to ME/CFS
- Developing ME/CFS biomarkers with diagnostic and prognostic utility
- Improving understanding of onset, triggers, etiology, and pathogenesis
Every area is important and the strategies to mitigate are insightful, informed and most importantly, achievable. It is also the case that the Roadmap has identified long-standing inadequacies in ME/CFS research which apply beyond the borders of the USA. Countries world-wide and national funding agencies would do well to read and consider how their situations align with the gaps and how they could implement the Roadmap’s recommendations.
