
東新宿クリニック 院長
丸山 達也(まるやま たつや)
新しい医薬品・医療機器が保険診療で使えるようになるために、その効果の科学的根拠を作る『治験』のステップは非常に重要で、参加して頂く皆様のボランティア精神に支えられています。その皆様の気持ちにお応えして、皆様の安全性を確保しながら高品質の治験を実施し、新しい医薬品・医療機器のより早期な承認につながる正確なデータを迅速に提供できるように、2011年の開設以来、当院のスタッフ全員は常にGCPを遵守し高い倫理性を維持しながら、小規模施設の特性たる柔軟性と機動性を生かしたより緻密な治験実施体制を構築してきました。2021年には 慶幸会グループとなることで一層強固な体制となり、様々な治験を実施しております。
21世紀を迎え分子標的薬や生物製剤、再生医療等製品といわれる新しいモダリティの医薬品が実用化されるようになり、安全性や有効性を確認する治験のステップはますます重要になってきています。当院治験部門は少人数での運営ながら、数十人規模から300例を超える大規模治験まで、その内訳も後発医薬品の同等性試験やグローバルに開発が展開する新規薬剤の第二・三相試験、また医療機器や健康食品を対象とした試験など、様々な治験の経験があり、また核酸医薬品等新しいモダリティの治験の実績も重ねてきました。
また昨今では、情報技術(IT)の目覚ましい進歩により、治験に参加する皆様の来院等の負担を減らすことのできる、分散型臨床試験(Decentralized Clinical Trial、DCT)の実施も可能になってきています。当院ではこれまでも患者さんや被験者の方を中心に考える治験(patient-centric clinical trial)を実施してきましたが、DX(Digital Transformation)を加速しながらこうした新しいDCTの導入も検討し、よりグローバルな趨勢に順応した治験実施も視野に、当院では今後も被験者の方、治験依頼者の方、皆様にとってより正確かつ迅速、高品質で快適な治験の実施を目指してまいります。
It is extremely critical to perform clinical trials to create scientific evidence for launch of new medicines or medical devices. Clinical trials are supported by the volunteer spirit of everyone who participates in.
To live up to this spirit, all the staff of our clinic have been constructing a sophisticated system, that dedicated staff in a smaller sized facility like us may achieve, for conducting high-quality clinical trials since we were established in 2011. We are always complying with GCP (both ICH-GCP and the local specific regulation) and are maintaining high ethical standards, resulting in ensuring your safety and in swiftly providing accurate data that will lead to faster approval of new medical products.
In 2021, we became a member of the Keiko-kai Group, which further strengthened our organization for clinical trials, and we have been conducting a variety of clinical trials.
In the 21st century, new modalities of pharmaceuticals, such as molecularly targeted agents, biologics and regenerative medicines, have been put into practical use, and clinical trials to confirm their safety and efficacy are becoming more important. We have experienced in a wide range of clinical trials in size, from smaller trials with dozens of subjects to large-scale trials involving more than 300 subjects. They consist of biologic equivalence trials for launch of generic products, phase II or III trials for globally-developing new products, trials for new medical devices and those for health products. And furthermore, we have also accumulated experience in clinical trials for further new modalities such as nucleic acid drugs.
In recent years, the remarkable progress in information technology (IT) has made it possible to conduct decentralized clinical trials (DCT), which can reduce the burden of direct visits to sites in clinical trials. Whereas we have been conducting patient-centric clinical trials since the establishment, we are now also working on the implementation of these new DCTs while accelerating DX (Digital Transformation) to implement higher quality for patients, sponsors and everyone else.
2025年4月
東新宿クリニック院長
丸山 達也