Ethical issues of using placebo in antiepileptic drugs trials in Asia

ABSTRACT

Any human trials should be designed and conducted within the ethical framework of the “Declaration of Helsinki” stating that any new agent must be tested against standard, proven therapies when available. In the clinical development of antiepileptic drugs, a double-blinded, placebo-controlled study is generally considered the gold standard for establishing their clinical effi cacy. However, placing patients with epilepsy on placebo is unethical because of negative impact of subsequent seizures resulting from “nontherapy”. The ethical concern is relatively small in an add-on trial but becomes problematic when a monotherapy is designed. Asia is expected to play a key role for future clinical development of new antiepileptic drugs. Timely action and collaborations of Asian epilepsy communities for advances in future clinical trials seems high in priority.