Healthcare associated infections in north carolina 2012

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In some cases, this means adapting current approaches to deal with ethical considerations that do not arise in conventional drug development. For example, US researchers Jon Tilburt and Ted Kaptchuk have suggested that clinical trials of traditional medicines should follow different standards of research ethics (See Box 2). [7]

Box 2: Ethical research standards for clinical trials with traditional medicines*

Social need that justifies the research

The argument for testing a traditional remedy in a clinical trial cannot be the simple fact that it already exists as a treatment. There must be both a social need and some preliminary evidence that the medicine will not counteract the effect of others used to treat the same disease. Different stakeholders will differ in their definition of social need: for example, a government may want to prevent any involved actor from commercializing the treatment, while health promoters will want the clinical trial to lead to better drugs.

Appropriate definitions of inclusion/exclusion criteria and outcome measures

  • The concepts of health and disease differ in traditional and modern medicine. For example, Western researchers will tend to categorize heart failure according to the New York Heart Association classification.
  • But those who practice traditional Chinese medicine (TCM) will see it as a deficiency of yang chi of the heart or a deficiency of kidney yang, categorizing patients based on the examination of the pulse or the tongue.
  • Researchers testing an herbal medicine for heart failure should consider both biomedical and TCM criteria so that the results are valid from both perspectives.

Innovative protocol design

Drugs derived from traditional remedies that are brought to market after passing clinical trials must pass strict tests, but researchers have to think carefully about how to design protocols.

Conventional methodologies may not be appropriate for a medicine that contains a mixture of active ingredients or in the case of therapies that vary from physician to physician. Even so, the adaptation of standardized protocols could contemplate many of these aspects. For example, cluster randomized controlled trials could be rigorous while allowing for professional variation.

Establish security and evidence standards

The familiarity of traditional medicines, and their widespread use, might bias some researchers towards a favorable safety profile, but caution is needed from the outset to determine safety requirements.

  • Establish security and evidence standardsAdapted from an ethical analysis by Jon Tilburt and Ted Kaptchuk. [7]
  • intrinsic variability

Ethical issues aside, it is extremely difficult to apply modern methods (developed to test standardized drugs) to the inherently broad spectrum of traditional remedies.

Many traditional medicines are produced by crushing the leaves or bark of plants and trees, and the resulting mixture can contain hundreds of potentially active molecules. Identifying them is already quite laborious; verify the efficacy and safety of all, practically impossible.

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