Conduct of trials in private clinical practice.
OBJECTIVE
Trials of antiepileptic medications are usually based in tertiary referral centers with teaching hospital resources. Epilepsy Research & Services (ERS) is part of a private outpatient neurological clinic that is involved in research as part of multicenter clinical trials, adhering to Good Clinical Research Practice. ERS is subject to external monitoring and auditing, but does so outside of the teaching hospital environment.


METHODS
The clinic is operated by a neurologist supported by a research assistant, administrative and nursing staff and has no formal university attachment. Patients are recruited for trials from routine referrals for clinical care. The center has formal ties with the ethics committee of the local teaching hospital, but none of the team is formally attached to that hospital.


RESULTS
The center conducted trials of zonisamide, oxcarbazepine, gabapentin, remacemide, tiagabine, vigabatrin, felbamate, and lamotrigine both as add-on trials in refractory seizure disorders and as monotherapy trials in de novo epilepsy. More than 200 patients have been recruited for trials at ERS (with some patients being involved in more than one trial). External review endorsed ERS as a superior environment for such research and as a model for other centers.


CONCLUSIONS
Private practice is a viable alternative for the conduct of clincial trials and should be considered when establishing such protocols. Simplicity of administration and clinical practice, which more closely mirrors standard patient care, may enhance recruitment and management.
Beran
R G
RG
Epilepsy Research & Services, Chatswood NSW, Australia. Roy.Beran@unsw.edu.au
Beran
M E
ME
D000554:Ambulatory Care Facilities / Q000191:economics / Q000592:standards; D000927:Anticonvulsants / Q000627:therapeutic use*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000592:standards; D004827:Epilepsy / Q000188:drug therapy*; D017041:Ethics Committees; D006801:Humans; D008485:Medical Audit; D015337:Multicenter Studies as Topic; D009462:Neurology / Q000592:standards; D018579:Patient Selection; D010865:Pilot Projects; D011331:Private Practice / Q000191:economics / Q000592:standards / Q000706:statistics & numerical data*; D012107:Research Design / Q000592:standards
D000927:Anticonvulsants