Conduct of trials in private clinical practice.

Abstract:

PURPOSE: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.

journal_name

Epilepsia

journal_title

Epilepsia

authors

Beran RG,Beran ME

doi

10.1111/j.1528-1157.2000.tb00256.x

subject

Has Abstract

pub_date

2000-07-01 00:00:00

pages

875-9

issue

7

eissn

0013-9580

issn

1528-1167

journal_volume

41

pub_type

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