Equipoise research

The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal was launched in 2009 following growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal disorders. JNIS is published by BMJ on behalf of SNIS, it is also the official journal of the Interventional Chapter of ANZSNR, CING, HKSITN and the INR Chapter of NRST.

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments, A and B, is to be cognitively indifferent between the statement 'A is strictly more effective than B' and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomized assignment to treatments A and B to be beneficent and non-maleficent and is sufficient for such an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise-like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper, I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent.

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To conclude, there is much contention and little transparency in regards to clinical equipoise.  Researchers are ethically obligated to provide participants with the best known treatment available, if there is one.  This prohibits the use of placebos somewhat as placebos are classed as non-treatment.  However, prohibiting the use of placebo’s can harness the progression of scientific/clinical research.   Miller and Brody (2003) argue that clinical therapy and clinical research should be treated as separate entities, and researchers should be aware of this, ensuring that their participants are also aware of this.  There are two contradictory positions dominating the discussion on clinical equipoise; the similarity position and the difference position.  With two such divergent views there is a need for strict regulations and guidelines, the World Medical Association’s Declaration of Helsinki Paragraph 29 appears to be contradicted by their own clarification issued more recently in 2001.  In an attempt to end the confusion, they added to it emphasising the need for something transparent.  The US Food and Drug Administration’s (FDA) policy appears to have provided it, with clear guidelines.

Equipoise research

equipoise research

To conclude, there is much contention and little transparency in regards to clinical equipoise.  Researchers are ethically obligated to provide participants with the best known treatment available, if there is one.  This prohibits the use of placebos somewhat as placebos are classed as non-treatment.  However, prohibiting the use of placebo’s can harness the progression of scientific/clinical research.   Miller and Brody (2003) argue that clinical therapy and clinical research should be treated as separate entities, and researchers should be aware of this, ensuring that their participants are also aware of this.  There are two contradictory positions dominating the discussion on clinical equipoise; the similarity position and the difference position.  With two such divergent views there is a need for strict regulations and guidelines, the World Medical Association’s Declaration of Helsinki Paragraph 29 appears to be contradicted by their own clarification issued more recently in 2001.  In an attempt to end the confusion, they added to it emphasising the need for something transparent.  The US Food and Drug Administration’s (FDA) policy appears to have provided it, with clear guidelines.

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