INTRODUCTION: Clinical trials of new agents enhance treatment options. Such trials are usually conducted in large tertiary referral centres, rather than the private practice setting. This paper reports the experiences of a private outpatient neurological clinic, which conducts such trials as part of its commitment to improve patient care and offers suggestions, which may be used to review the approaches of others involved in such trials. METHODS: Strategic Health Evaluators P/L (SHE) is the research arm attached to the clinic and at any one time would have 5 - 6 trials running concurrently. Conducting such trials has necessitated the development of new approaches to: patient recruitment; achieving informed consent; interactions with various players, including sponsors, monitors and ethics committees; staffing and equipment; dispensing; and sequestrated financial records. RESULTS: Acknowledging lack of equipoise between patient and doctor, the clinic developed a novel approach to informed consent. The clinician introduces the study, the trial coordinator performs most of the duties of obtaining informed consent and, only if entry is accepted, does the doctor complete the exercise, countersigning and thereby taking ultimate responsibility for the process, which enhances patient autonomy.
The trial co-ordinator ensures: all trial-related activities are properly supervised with adequate checks and balances: ensures patients get proper supervision; that trial requirements are properly administered; and that contact is maintained with all those involved with study-related activities, including supervisors, monitors, ethics committees, office staff and the clinician and correspondence and source data are verified and countersigned and dated.
All financial transactions, relevant to the conduct of trials, are sequestrated from standard practice finances. No trial-related visits or activities are charged to the universal health insurer and records are maintained in separate spreadsheets, individually referable to each trial. DISCUSSION: Trials conducted in private practice allow patients access to novel treatments without referral to a tertiary institution, thereby maintaining continuity of care. The recruitment base is broader and may better reflect 'real world’ practice.
The private practice setting generates different pressures and ethical expectations. This paper discusses these demands and how they are addressed and offers concepts that could be transposed throughout the wider scientific community. The novel approach to informed consent provides additional scope for patient’s autonomy. Having all material reviewed by the trial co-ordinator and initialled and dated by the principal investigator, adds an additional dimension to confirming source data and complement validity. The system applied additional checks and balances which could be used by others involved in such research.