First of all, a big thank you for your participation in the Merck study, and for sticking around for the last few months until now!
As we get into the final phase of data collection, we thought of sharing some important updates about the study with you.
- First, this study has made an enormous contribution to research into new MS treatments. The two new questionnaires developed and tested in this research are now included in two Phase III multiple sclerosis trials – EVOLUTION I & II. Specifically, fatigue symptoms and physical function are being assessed in these trials as “secondary endpoints”, based on the new questionnaires.
- Second, Merck’s collaboration with other companies and health authorities responsible for approving new medicines in the US – the FDA, through the Critical Path Institute PRO Consortium, continues. Specifically, this initiative is seeking to get the two new questionnaires (fatigue and physical function) to be accepted and approved by the authorities as standard clinical trial outcomes. This would encourage other companies and research to evaluate how treatments directly impact fatigue and physical function, which represent outcomes that are important for people with MS. In June 2020, the consortium received new funding from the FDA to fast-track work focusing on the PROMIS physical function questionnaire.
- Further, we continue to present results from this work at various scientific and international conferences. We are particularly excited to be presenting at the European Committee For Treatment and Research in Multiple Sclerosis (ECTRIMs) Annual Congress this September. This is the world’s largest professional organization dedicated to the understanding and treatment of Multiple Sclerosis. Of course, we’ll be sharing with you the posters and links in due course.
- Finally, with the current study winding up this autumn, we are already back to the drawing board to design and plan further research, to be initiated in the near future. Watch this space.
- I hope you and your family stay safe in these unusual times.