February 16, 2021
International Progressive MS Alliance (the ‘Alliance’) Makes Recommendations for Improving Early Phase Clinical Trials
Disease-modifying therapies for relapsing-remitting forms of MS have advanced greatly, but few therapies target the neurodegeneration and compartmentalized inflammation found in progressive forms of MS. An expert panel assembled by the Alliance published an article in Nature Reviews Neurology recommending changes in the way progressive MS clinical trials are designed and conducted to encourage consistency and improve comparability.
Under the leadership of co-chairs, Drs. Marco Salvetti (Sapienza University and INM) and Fernando Dangond (representative of the Alliance’s Industry Forum), the team developed and published recommendations for improving phase II trials.
Expert Panel Recommendations:
- Phase II clinical trials can and should be informative about disease mechanisms even if their results are considered negative;
- Multiple therapies can be tested at the same time using advanced trial designs;
- Testing new therapies in combination with an approved MS therapy to reduce the potential interference of inflammation on trial results;
- Using diverse measures of disease biology, on top of a core set of outcome measures to track an experimental medicine’s effects.
- Using less restrictive criteria for characteristics of people to be included in a trial;
- Using alternative clinical trial designs; and
- Soliciting feedback on feasibility of trial designs from people living with MS.
Potential Impact: Through this publication, the Alliance is inviting comments on these recommendations from the broader MS community. These comments will help the Alliance shape a future funding program for phase II experimental medicine trials.
Reference: “Facing the urgency of therapies for progressive MS — a Progressive MS Alliance proposal,” by Dangond, F., Donnelly, A., Hohlfeld, R., et al, was published in Nature Reviews Neurology on January 22, 2021 (Nat Rev Neurol (2021). https://doi.org/10.1038/s41582-020-00446-9)
About the International Progressive MS Alliance
The Alliance exists to accelerate the development of effective treatments for people with progressive forms of multiple sclerosis to improve quality of life worldwide. It is an unprecedented global collaboration of MS organizations, researchers, health professionals, the pharmaceutical industry, companies, trusts, foundations, donors and people affected by progressive MS, working together to address the unmet needs of people with progressive MS ─ rallying the global community to find solutions. Our promise is more than hope, it is progress.