Justification for conducting neurological clinical trials as part of patient care within private practice.

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.

Opinions, attitudes and practices of Australian neurologists with regard to epilepsy and driving.

INTRODUCTION: Austroads Guidelines for fitness to drive were promulgated in 2003. Epilepsy was one of the conditions included and this paper reports results of a survey of Australian neurologists regarding opinions and practices relevant to the guidelines. METHODS: The survey was developed, piloted and Human Research Ethics Committee approved. Members of the Australian Association of Neurologists received three mailings and results were analysed. RESULTS: Almost 70% of 236 surveyed indicated assessment of epilepsy and driving with <9% not doing so--establishing approximately 77% response for eligible neurologists. Most questions achieved 90% response. Almost 90% respondents assessed epilepsy and 70% found the guidelines helpful. Seventy-seven per cent endorsed doctor assessors although half discounted General Practitioners as insufficiently knowledgeable and half advocated that only neurologists evaluate potential drivers with epilepsy. Most respondents supported reporting recalcitrant patients; yet only <30% did so. Three-quarters favoured licences carrying a warning to self-report and two-thirds felt that product information should identify driving implications. Although many questions attracted expected responses, the surprise was the large undecided numbers, which were greater than expected. Neurologists were more lenient than prescribed by the guidelines with neither consensus for controlled epilepsy nor mandatory driving restrictions. CONCLUSION: 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.

Ethics in clinical drug trial research in private practice.

INTRODUCTION: Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. METHODS: Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. RESULTS: The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. DISCUSSION: Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.

Conduct of trials in private clinical practice.

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.