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Can non-fundable trials be conducted anyway? The case for open, randomised, actively controlled trials in rheumatology
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Introduction |
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Clinicians are encouraged to practice "evidence-based
medicine", a term implying that a practitioner can access, summarise, and apply information from the literature to day to day clinical problems and questions.1 But how convincing should the
evidence be for a clinician to accept the data and adopt the approach
into his or her practice? Undoubtedly the double blind, placebo
controlled, randomised trial remains as the ultimate tool for gathering
the strongest evidence of therapeutic efficacy and safety. However, this study design is at times unfeasible, unethical or may not even be
appropriate for obtaining the information needed (for example, long
term outcome), and less stringent alternatives have to be
considered.2 3 In rheumatology, where the optimal
therapeutic approach to many conditions is still uncertain, approved
drugs are frequently used "off label" (implying that the agent is
being used to treat a disease for which it has not gained formal
approval, or at
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