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A need to continually assess the design of current and future research …


Biology Articles » Bioethics » Ethical and practical issues in conducting clinical trials in psoriasis and psoriatic arthritis » Distributive justice

Distributive justice
- Ethical and practical issues in conducting clinical trials in psoriasis and psoriatic arthritis

As clinical trials have increasingly become multinational, ethical considerations have been raised not only about the studies but about the treatment of patients after studies have been completed.13,14 One issue relates to study design. If the standard of care for the treatment of patients with psoriasis or psoriatic arthritis is different in a given country, is it ethical to design a study based on that standard, even if such a study would not be considered ethical in another country with greater resources and a higher standard of care? Another concern relates to continued treatment of patients after a study is complete. The Declaration of Helsinki asserts that, "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic, and therapeutic methods identified in the study". The efficacy of highly effective agents, such as the TNF inhibitors, raises issues in both those countries where they are available commercially and those countries where they are not. What is the responsibility of the sponsoring company as regards continuing to provide medication to study patients after a study is done but before the agent is commercially available?


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