MS clinical trial design for the future.

The Clinical Outcomes Task Force has been challenged to develop new easily administered composite outcomes that are more sensitive, highly reliable, properly validated, and measure more effectively the broad spectrum of independent dimensions of MS. The Task Force on Use of MRI in MS Clinical Trials has already provided important position statements and recommendations for the use of magnetic imaging technologies in MS clinical trials. It appears that TIWGd + activity and change in T2W lesion burden will be most useful as outcomes in patients who recently have experienced frequent relapses. It is anticipated that improved composite outcomes and more powerful statistical methods will facilitate improved predictive validity for MR imaging techniques. If we are successful in meeting these challenges, we should be able to conduct future definitive clinical trials more expeditiously and with fewer patients.