TY - JOUR
T1 - Clinical Trials in Neurovirology
T2 - Successes, Challenges, and Pitfalls
AU - Haubenberger, Dietrich
AU - Clifford, David B.
N1 - Publisher Copyright:
© 2016, The American Society for Experimental NeuroTherapeutics, Inc. (outside the U.S.).
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Clinical trials in neurovirology illustrate the special challenges confronting investigators planning to study these conditions, as well as the contributions of successful trials in establishing appropriate management for these devastating diseases. This article reviews key examples of progress in neurovirology that have been spurred by clinical trials, emphasizing human herpes virus encephalitis, HIV, and JC virus. Clinical trials in the setting of neurovirological diseases are characterized by specific challenges, which may include small sample sizes, clinical presentations from life-threatening conditions to chronic courses of disease, regional and temporally restricted outbreaks scenarios, and the unavailability of validated diagnostic tests that can be rapidly deployed at the bedside. This review aims to highlight these methodological challenges and pitfalls in designing and executing clinical neurovirology trials, as well as to outline innovative trial designs, which could be useful in addressing common challenges.
AB - Clinical trials in neurovirology illustrate the special challenges confronting investigators planning to study these conditions, as well as the contributions of successful trials in establishing appropriate management for these devastating diseases. This article reviews key examples of progress in neurovirology that have been spurred by clinical trials, emphasizing human herpes virus encephalitis, HIV, and JC virus. Clinical trials in the setting of neurovirological diseases are characterized by specific challenges, which may include small sample sizes, clinical presentations from life-threatening conditions to chronic courses of disease, regional and temporally restricted outbreaks scenarios, and the unavailability of validated diagnostic tests that can be rapidly deployed at the bedside. This review aims to highlight these methodological challenges and pitfalls in designing and executing clinical neurovirology trials, as well as to outline innovative trial designs, which could be useful in addressing common challenges.
KW - Clinical trials
KW - ethics
KW - methodology
KW - randomization
KW - statistics
UR - http://www.scopus.com/inward/record.url?scp=84979911449&partnerID=8YFLogxK
U2 - 10.1007/s13311-016-0440-8
DO - 10.1007/s13311-016-0440-8
M3 - Review article
C2 - 27194073
AN - SCOPUS:84979911449
SN - 1933-7213
VL - 13
SP - 571
EP - 581
JO - Neurotherapeutics
JF - Neurotherapeutics
IS - 3
ER -