The 3rd Clinical Research Skill Advancement Workshop

 2015年1月9~11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3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医師/医薬統計学者2名と、日本からはがん臨床試験のリーダー6名とゲスト1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 3rd Clinical Research Skill Advancement Workshop” was held at the Harumi Grand Hotel in Chuo-ku, Tokyo, Japan, from January 9th through January 11th, 2015. The objective of the workshop was to cultivate “the next generation of clinical investigators in the cancer research field in Japan” who can formulate and lead hypothesis-driven clinical research and disseminate evidence from Japan to the world.
 At this 3rd 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-host this workshop.
 The workshop invited two medical doctor/clinical statisticians with broad experience in clinical trials from The University of Texas MD Anderson Cancer Center (U.S.A.), six Japanese clinical trial leaders as its instructors and 1 guest speaker. These faculty members offered lectures for Clinical Investigator and took the role of mentors at the workshop.
 Throughout the three-day workshop, there were four interactive sessions where attendees revised the protocol concept sheets that they had submitted when applying to the workshop. They refined and created presentation 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 [2015/1/9]

 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6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、「Work 1: Statistical Considerations for Early Phase Trials」、「Work 2: Statistical Considerations for Biomarker-Based Trials」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3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。
 下の写真上段は、左から、上野直人氏とJ. Jack Lee氏の講義の模様。下段は、左から森田智視氏の講義の模様とインタラクティブ・セッションの模様。

 Each day of the workshop included six “Work” sessions of lectures and discussions. The first day’s Work session focused on two topics: “Statistical Considerations for Early Phase Trials,” “Statistical Considerations for Biomarker-Based Trials.” During an interactive session, attendees were divided into Three groups by agents, and then presented and discussed their protocol concept sheets in their groups.
 Photos: Dr. Naoto T. Ueno’s lecture (upper left), Dr. J. Jack Lee’s lecture (upper right), Dr. Satoshi Morita’s lecture (lower left), and “interactive session” (lower right).

  • 上野直人氏の講義の模様
  • J. Jack Lee氏の講義の模様
  • 森田智視氏の講義の模様
  • インタラクティブ・セッションの模様

DAY 2 [2015/1/10]

 2日目のワーク・セッションは、Work 3 Translation Researchの3テーマ 「(1) Drug Development from Basic Research Perspective」、「Pragmatic Biomarker Development in Phase I/II Studies」、「Specific Examples of Translational Research Development: Using Women's Cancer Moonshots as an Example」について講義がありました。さらに、「Work 4: Pharmacokinetic and Pharmacodynamics’ Analysis in Phase I/II Studies」、「Work 5: How to Obtain an Approval from Global Companies 」「Work 6: Perspective of Pharmaceutical Companies: investigator initiated studies」の3つの講義がありました。また、インタラクティブ・セッションでは、1日目と同様に対象薬別に3つのグループに分かれ、各自のプロトコールコンセプトシートの革新性・影響力・仮説・リサーチデザイン・実行可能性・プレゼンテーションスキルについて、グループの皆でディスカッションしました。夜のインタラクティブ・セッションでは、各参加者はプロトコールコンセプトシートを完成度の高いものに仕上げるとともに、自身のコンセプトのプレゼンテーションススライドを作成しました。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。

 The second day’s Work session 3 covered three topics regarding Translation Research, (1) “Drug Development from Basic Research Perspective, (2) “Pragmatic Biomarker Development in Phase I/II Studies“, (3) “Specific Examples of Translational Research Development: Using Women's Cancer Moonshots as an Example”. Also Next Work sessions covered 3 topics, “Work4 Pharmacokinetic and Pharmacodynamics’ Analysis in Phase I/II Studies”, “Work 5: How to Obtain an Approval from Global Companies, and “Work 6: Perspective of Pharmaceutical Companies: investigator initiated studies”. In the interactive sessions, as on the previous day, the attendees were divided into three groups based on agents and discussed innovation, impact, hypothesis, research design, feasibility and presentation skills of their protocol concept sheets in their groups. All attendees refined a protocol concept sheet of their own and created presentation slides of the protocol concept sheet during the evening interactive session. At a “Meet the professors” session, attendees had opportunities for one-on-one meetings and talked about each issue.
 Photos: Dr. Hideyuki Saya’s lecture (upper left), Dr. Kazuto Nishio’s lecture (upper right), Dr. Chiyo Imamura’s lecture (lower left), and Dr. Masaru Iwasaki’s lecture (lower right).

  • 佐谷秀行氏の講義の模様
  • 西尾和人氏の講義の模様
  • 今村知世氏の講義の模様
  • 岩崎甫氏の講義の模様

DAY 3 [2015/1/11]


 On the third day, all attendees presented their presentation slides of the protocol concept sheets, and each presentation was followed by a 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 were awarded a certificate of completion of the workshop to each attendee.
 Photos: Attendee’s presentation (upper left and right), attendees and faculty members [Group Photos] (lower left and right).

  • 参加者による発表風景
  • 参加者による発表風景
  • 参加者とファカルティメンバーとの(各グループ)記念写真
  • 参加者とファカルティメンバーとの(各グループ)記念写真
  • 参加者とファカルティメンバーとの(各グループ)記念写真