In autumn of 2018, we launched a study in collaboration with Merck Healthcare KgaA, which seeks to provide a better understanding of the burden associated with MS symptoms and day-to-day impacts and how best to assess these.
In our September 2019 newsletter/update, we share with you that two new patient-friendly self-assessment questionnaires for fatigue and physical function had been tested and validated. These are already included in planned MS clinical studies, supporting research on new MS therapies.
The Merck study is still ongoing until November 2020, with the 18-month assessment window currently open. As the study continues, the research team has already started with analysis of data. Results from analyses of data collected as of October 2019 were presented at two conferences, the International Society of Quality of Life Research (ISOQOL), and the PROMIS Health Organization (PHO), in San Diego, California, in October 2019.
Here are links to the two posters that were presented.
As mentioned in our autumn (2019) update, Merck is participating in an initiative, the C-PATH PRO Consortium MS Working Group, alongside other pharmaceutical companies, and other organizations, to standardize assessments of fatigue and physical function in clinical trials used to test new MS therapies. Data from the current study are being used as key evidence supporting discussions with the US Food and Drug Administration (~the government agency responsible for evaluating and approving new drugs in the USA), as part of the initiative. If the initiative is successful, we expect to see an increase in trials including assessments of fatigue and physical function outcomes as important (i.e. secondary) outcomes, based on the new PROMIS questionnaires.
Once again, thank you for your continuous contribution to this important research.