Evaluation and registration of adverse events in clinical drug trials in migraine.
Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given.
Tfelt-Hansen
P
P
Danish Headache Centre, Department of Neurology, University of Copenhagen, Glostrup Hospital, Copenhagen, Denmark. ptha@glo.regionh.dk
Bjarnason
N H
NH
Dahlöf
C
C
Derry
S
S
Loder
E
E
Massiou
H
H
D016907:Adverse Drug Reaction Reporting Systems; D000700:Analgesics / Q000009:adverse effects* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012042:Registries
D000700:Analgesics