Inadequate outcome measures are the biggest impediment to successful clinical trials in progressive MS - YES.

نویسنده

  • Jeremy Chataway
چکیده

The closer progressive multiple sclerosis (MS) is approached, the more awkward it is to define and the more slippery it is to measure. Of course on one level it is easy – if 5 years previously a person affected by MS can walk or see or balance normally, but now they walk with a stick or have a visual acuity of 6/60 or are falling over, then it is clear (to anyone) that progression has occurred, whichever yardstick is used. No, the problem is that progression is (generally) slow, it is multidimensional and the time frequency of such very hard clinical end-points is too low to be of value in the 2-3 year life span of trials in progressive MS.

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Outcome Measures in Relapsing-Remitting Multiple Sclerosis: Capturing Disability and Disease Progression in Clinical Trials

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that manifests as acute relapses and progressive disability. As a primary endpoint for clinical trials in MS, disability is difficult to both characterize and measure. Furthermore, the recovery from relapses and the rate of disability vary considerably among patients. Given these challenges, investigators have devel...

متن کامل

Imaging outcome measures for progressive multiple sclerosis trials

Imaging markers that are reliable, reproducible and sensitive to neurodegenerative changes in progressive multiple sclerosis (MS) can enhance the development of new medications with a neuroprotective mode-of-action. Accordingly, in recent years, a considerable number of imaging biomarkers have been included in phase 2 and 3 clinical trials in primary and secondary progressive MS. Brain lesion c...

متن کامل

Possible clinical outcome measures for clinical trials in patients with multiple sclerosis.

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite...

متن کامل

The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force.

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g. , cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placeb...

متن کامل

Advancing trial design in progressive multiple sclerosis.

The failure of a majority of clinical trials in progressive multiple sclerosis (MS) has highlighted the need to reconsider how these trials are designed and conducted, and many areas deserve focus. Basic scientists are reconceptualising the pathophysiology of progressive MS into three broad areas: systemic inflammation, compartmentalized inflammation and non-inflammatory neurodegeneration, with...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:
  • Multiple sclerosis

دوره 23 4  شماره 

صفحات  -

تاریخ انتشار 2017