The Hottest Topic Right Now: Women's Menopause Trials! Expert Tips on Avoiding Common Pitfalls Before Implementation
更年期領域のヒト試験をお考えの皆様へ。SMI総合スコアだけに頼る評価やプラセボ反応の高さなど、更年期試験には特有の「罠」があります。本セッションでは、身体・精神・血管系症状の保有割合や日々の症状の波を踏まえた適切なスクリーニングと試験設計を解説。開発成功につながる検証のノウハウを伝授します。
For those considering human clinical trials in the menopause field. Menopause trials have unique traps, such as relying solely on SMI total scores and high placebo responses. This session explains appropriate screening and study design based on the prevalence of physical, psychological, and vasomotor symptoms, as well as daily symptom fluctuations, delivering validation know-how that leads to successful development.