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  • Ethics guidelines for care after drug trials revised

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Researchers conducting clinical trials should make clear their commitments to post-trial patient care before trials begin, according to a clarification of the Declaration of Helsinki, a set of ethical guidelines for scientists engaged in biomedical research.

Since the declaration was last revised in 2000, there have been calls the scientific community for further clarification of paragraph 30.

The paragraph, which reads: "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 by the study", has been called unrealistic.  

Critics of the paragraph say the financial costs of continuing care after a trial has ended might be beyond the capacity of many developing world countries, and study sponsors may be discouraged from funding trials with potentially high 'after-care' costs.

In response to these concerns, the World Medical Association added a footnote of clarification to the contentious paragraph during its general assembly in October. It states that provisions for post-trial care should be made clear before the trial starts both to ethics committees reviewing the protocol and to people who are considering taking part in the study.

The full text of the footnote reads: The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.
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