Summary: 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, oxcar‐bazepine, 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.
Respondents supplied predictable answers regarding ideal circumstances; yet most did not report recalcitrant patients. Most claimed to adhere to the guidelines and yet advocated more lenient driving restrictions that may allow preventable accidents. There was agreement between neurologists and guidelines for more rigorous restrictions for commercial drivers although again neurologists were more lenient. There is need for prospective research on epilepsy and driving.
Summary The aim of this review was to assess the benefits and drawbacks of conducting neurological clinical trials and research in private practice for the patients, clinician, Practice Manager, sponsors/Clinical Research Organisations (CROs) and Clinical Trial Coordinator (CTC) to determine if this is justified for all involved. A combination of literature reviews, original research articles and books were selected from 2005 to 2015. Provided that the practice has sufficient number of active trials to prevent financial loss, support staff, adequate facilities and equipment and time, the benefits outweigh the drawbacks. Clinical trials provide patients with more thorough monitoring, re‐imbursement of trial‐related expenses and the opportunity to try an innovative treatment at no charge when other options have failed. For the clinician, clinical trials provide more information to ensure better care for their patients and improved treatment methods, technical experience and global recognition. Trials collect detailed and up‐to‐date information on the benefits and risks of drugs, improving society's confidence in clinical research and pharmaceuticals, allow trial sponsors to explore new scientific questions and accelerate innovation. For the CTC, industry‐sponsored clinical trials allow potential entry for a career in clinical research giving CTCs the opportunity to become Clinical Research Associates (CRAs), Study Start‐Up Managers or Drug Safety Associates.
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