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37 Med. & L. 27 (2018)
Conducting Clinical Trials in Private Practice

handle is hein.journals/mlv37 and id is 33 raw text is: Med Law (2018) 37:1:27-36 Medicine and Law World Association for Medical Law CONDUCTING CLINICAL TRIALS IN PRIVATE PRACTICE Roy G Beran *, **,***, Sandiya Sathiyaseelan ***, Glynda K Hurley * and Maureen E Beran * Abstract: Introduction Clinical trials of new agents increase treatment options. Such trials are usually conducted in large tertiary referral centres rather than in 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 by others 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 members of the research team, including sponsors, monitors and ethics committees; staffing and equipment; drug 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 accepting ultimate responsibility for the process, which enhances patient autonomy. * University of New South Wales, South-Western Clinical School of Medicine, Sydney, Australia. Email: roy@royberan.com ** Griffith University, School of Medicine, Queensland, Australia *** Strategic Health Evaluators, Level 6, 12 Thomas Street, Chatswood NSW 2067 27

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