Randomised control trials

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  • #4148

    Hi,
    I would like to get your views on randomised control trials in which double blind is used in regard to research ethics.
    Cheers

    #4149

    One of the challenges of informed consent in clinical trials is that the understanding of basic scientific method is low in the general population. “Experimental design is difficult to present in a simple, understandable, and accurate way. Another is that participants in clinical trials are often so heavily invested (sometimes as a life and death issue) that they ignore the full telling of the consent document. The ethical question is whether the subjects understand the methods to be employed, the risks, the benefits (and who benefits), there ability to withdraw without consequence for any care, whether they feel coerced to participate or not.

     

    My observation would be that the ethical dimensions of randomized double-blind clinical trails are well defined. The ethical challenge has been in implementation. For example, How can an existing patient understand that, by participating, they are now a subject of research, not a patient? When a care provider refers their patient to a clinical trial as being “a last hope” how, ethically can the researcher obtain true consent ethically without diabusing them of the element of hope for a cure?

     

    Another undeveloped ethical issue is that surrounding the decision to suspend a clinical trial having positive outcomes and to make the intervention generally available. How do we know when the risk of a poor call then will outweigh the seeming benefits realized by a small clinical trial population? What is ethical about making a usually limited, not-yet-in production, experimental drug accessible to only a small segment of an affected population?

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