Commonalities and challenges in the development of clinical trial measures in neurology.
As neurologists and neuroscientists, we are trained to evaluate disorders of the nervous system by thinking systematically. Clinically, we think in terms of cognition, behavior, motor function, sensation, balance and co-ordination, and autonomic system function. But when we assess symptoms of neurological disorders for the purpose of drug development, we tend to create disease-specific outcome measures, often using a variety of methods to assess the same types of dysfunction in overlapping, related disorders. To begin to explore the potential to simplify and harmonize the assessment of dysfunction across neurological disorders, a symposium, entitled, "Commonalities in the Development of Outcome Measures in Neurology" was held at the 16th annual meeting of the American Society for Experimental NeuroTherapeutics (ASENT), in February 2014. This paper summarizes the presentations at the symposium. The authors hope that readers will begin to view Clinical Outcome Assessment (COA) development in a new light. We hope that in presenting this material, we will stimulate discussions and collaborations across disease areas to develop common concepts of neurological COA development and construction.
Neurology Early Clinical Development, Biogen Idec, 14 Cambridge Center, Cambridge, MA, 02142, USA, jesse.cedarbaum@biogenidec.com.
Jesse M
JM
Cedarbaum
Diane
D
Stephenson
Richard
R
Rudick
Maria C
MC
Carrillo
Glenn
G
Stebbins
Douglas
D
Kerr
Jill
J
Heemskerk
Wendy R
WR
Galpern
Petra
P
Kaufmann
David
D
Cella
Maria
M
Isaac
Marc K
MK
Walton
D002986:Clinical Trials as Topic; D006801:Humans; D009462:Neurology / Q000379:methods*; D017063:Outcome Assessment, Health Care / Q000379:methods*