研究者主導臨床研究における支援組織—DIAN研究

Support Team for Investigator-Initiated Clinical Research

アカデミアでは研究者が自身の臨床研究を計画し結果を見出す研究者主導臨床研究が多く実施されている。規模の大きい臨床研究にあっては，単独ではなくチームを編成して実施していくこととなる。そしてそのチームには，研究者のほか支援スタッフも含まれ，それぞれの役割を果たすことで円滑な研究推進につながる。本論では臨床研究支援の現状を述べるとともに，DIAN研究の研究者主導国際臨床研究を実施した際の支援組織を紹介する。

Abstract

Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.