The 2nd Clinical Research Skill Advancement Workshop

 2014年1月10~12日の3日間、東京都中央区の晴海グランドホテルにおいて、「仮説に則った臨床研究を自ら立案・主導し、日本から世界に向けてエビデンスを発信できる、がん領域における次世代のClinical Investigatorの育成」を目指した “Clinical Research Skill Advancement Workshop” の第2回目となるワークショップが開催されました。
 ワークショップには、米国テキサス大学MDアンダーソンがんセンターから、臨床試験の経験豊富な腫瘍内科医と医薬統計学者各1名と、日本からはがん臨床試験のリーダー5名が講師として招聘され、Clinical Investigatorにとって必要な知識についての講義と、そしてメンターとしての役割を担っていただきました。

 “The 2nd Clinical Research Skill Advancement Workshop” was held at the Harumi Grand Hotel in Chuo-ku, Tokyo, Japan, from January 10th through January 12th, 2014. The objective of the workshop was to cultivate the next generation of clinical investigators in cancer research in Japan who can formulate and lead hypothesis-driven clinical research and disseminate evidence from Japan to the world.
 At this 2nd workshop, we aimed at early clinical trials (phase I or phase II) using unapproved agents and/or off-label drugs, which are common in physician-initiated clinical studies in the EU and the US. We solicited the participants for protocol concept sheets using agents including the ones in the development pipelines of pharmaceutical companies that co-hosted this workshop.
 The workshop invited a medical oncologist and a clinical statistician with broad experience in clinical trials from The University of Texas MD Anderson Cancer Center (U.S.A.) and five Japanese clinical trial leaders as its instructors. These faculty members offered lectures on what clinical investigators do and took a role of mentor at the workshop.
 Throughout the three-day workshop, there were five interactive sessions where attendees revised the protocol concept sheets that they had submitted when applying to the workshop. They refined their protocol concept sheets and created presentations including slides for their protocol concept sheets. Through this experience, they learned the development process of clinical research design.
 The following are highlights of the three-day workshop, including some photographs.

DAY 1 [2014/1/10]

 3日間のワークショップ中、講義とディスカッションからなる7つのワーク・セッションが行なわれました。1日目のワーク・セッションは、「用量決定に関する第I相試験デザインについての統計的考慮」、「第Ⅰ/Ⅱ相試験、単群第II相試験およびランダム化第II相試験に関する統計的考慮」の2テーマについて行なわれました。またインタラクティブ・セッションでは、臨床試験の対象薬別に4つのグループに分かれ、参加者は各自のプロトコールコンセプトシートを発表し、グループの皆でディスカッションしました。また、“Meet the professors”のセッションでは、参加者の個人面談の機会がもたれ、それぞれの課題について話し合われました。
 下の写真上段は、左から、会場風景とJ. Jack Lee氏の講義の模様。下段は、左からインタラクティブ・セッションと“Meet the professors”の模様。

 Each day of the workshop included seven “Work” sessions of lectures and discussions. The first day’s Work session focused on two topics: “Statistical Considerations for Phase I Trial Designs for dose‐finding,” “Statistical Considerations for Phase I/II, Single-Arm Phase II and Randomized Phase II Studies.” During an interactive session, attendees were divided into four groups by agents, and then presented and discussed their protocol concept sheets in their groups. At a “Meet the professors” session, attendees had opportunities for one-on-one meetings and talked about each issue.
 Photos: workshop room (upper left), Dr. J. Jack Lee’s lecture (upper right), interactive session (lower left), and “Meet the professors” (lower right).

DAY 2 [2014/1/11]

 下の写真上段は、左から、朴 成和氏の講義の模様とインタラクティブ・セッションの模様。下段は、左から上野直人氏の講義の模様と、夜のインタラクティブ・セッションの模様(参加者が各自のプレゼンテーションスライドの最終仕上げにかかっているところ)。

 The second day’s Work session covered three topics: “Lessons from Experience of Phase I Trial Using Oral Agents,” “Practical Considerations for Study Conduct and Report” and “Successful ITT Development. How to increase your chances.” In the interactive sessions, as on the previous day, the attendees were divided into four groups based on agents and discussed innovation & impact, research design & feasibility and presentation skills of their protocol concept sheets in their groups. All attendees refined their protocol concept sheet of their own and created presentation slides of the protocol concept sheets during the evening interactive session.
 Photos: Dr. Narikazu Boku’s lecture (upper left), interactive session (upper right), Dr. Naoto T. Ueno’s lecture (lower left), and evening interactive session, showing attendees finalizing their presentation slides (lower right).

DAY 3 [2014/1/12]


 The third day’s Work session started with Dr. Masahiro Tsuboi’s presentation on “Basic Attitude for Contributing Clinical Trials.” All attendees then gave presentations using the slides each had created for their protocol concept sheets. Each presentation was followed by lively discussion among the participants. After the presentations, all faculty members offered a Q & A panel discussion. The day ended with a completion ceremony at which faculty members presented certificates of completion to the workshop attendees.
 Photos: Dr. Masahiro Tsuboi’s lecture (upper left), attendee’s presentation (upper right), panel discussion (lower left), attendees [Group A] and faculty members (lower right).