Clinical development of new prophylactic antimalarial drugs after the 5th Amendment to the Declaration of Helsinki.

摘要: Malaria is of continuing concern in nonimmune traveling populations. Traditionally, antimalarial drugs have been developed as agents for dual indications (treatment and prophylaxis). However, since 2000, when the 5th Amendment to Declaration Helsinki (DH2000) was adopted, development new malaria prophylaxis this manner has ceased. As a consequence, there may not be any licensed indication foreseeable future. Major pharmaceutical companies interpreted DH2000 mean that traditional paradigm considered unethical because doubt over likelihood benefit endemic populations participating clinical studies, use placebo, sustainability post-trial access study medications. In article, we explore basis these concerns suggest remains ethical under certain circumstances. We also consider alternative approaches more attractive sponsors they either do or utilize countries who unambiguously benefit. These represent way forward future, but are at present unproven practice, face numerous regulatory, logistical technical challenges. Consequently, short term, argue most feasible approach consistent with spirit appropriate