An increasing number of clinical trials recently require the submission of examination data as sample to check the feasibility of the study before the trials are started. However, procedures to ...obtain informed consent have not been standardized. Therefore, we investigated various procedures by reviewing past cases and guidelines on research ethics and personal information protection. Based on this review, we developed the procedures for four types of study classified according to the prospective nature and degree of invasiveness of the examination. In type A, when the sample data is prospective and requires implementation of invasive examination not conducted as part of routine medical care, written informed consent is mandatory and each examination must be approved by the institutional review board (IRB). In type B, when the sample data is prospective and requires implementation of less invasive or non-invasive examination not conducted as part of routine medical care, use of pre-approved template of written informed consent that includes explanations of foreseeable risks and inconveniences accompanying the examination is required. In type C, when the sample data is prospective and uses results of examination conducted as part of routine medical care, informed consent can be obtained either orally or in writing at the discretion of the investigator. In type D, when the sample data uses preexisting medical data, efforts have to be made to obtain oral informed consent as far as possible. However, if informed consent is not possible, individual informed consent can be omitted but general notice should be given to patients regarding use of their medical records for purposes including answering inquires on medical services from other medical institutions. This classification system, which includes flowcharts and templates for informed consent, has been approved by the IRB at the University of Tokyo Hospital and will facilitate proper handling of sample data.
The University Hospital Clinical Trial Alliance(UHCT Alliance) was established in 2006 with the goal to conduct global studies in Japan, and is presently organized by 7 national university hospitals ...in the Kanto and Shin-Etsu area. To promote more efficient and safer clinical trials, we have been considering the possibility of a centralized IRB(CIRB) system in the Alliance. The outline of our plan is as follows: One of the university hospitals selected for a clinical trial is responsible for both Cooperative Hearing and CIRB, resulting in a shift of the site in charge of member hospitals in the Alliance. The CIRB should review not only “ethical and scientific issues” but also “local issues” such as qualifications of the investigators and the institutions. The CIRB should conduct continuing review of each ongoing trial. In the case of occurrence of significant adverse events in a member hospital, the site voluntarily offers opinions to the CIRB. Low efficiency caused by a small number of member hospitals and the CIRB shifting system seems to be the most serious problem in our plan. A CIRB for three Alliance members, similar to the Alliance system, has been working in an investigator-initiated clinical trial since July 2010. This ongoing system will provide more information about the advantages and disadvantages of our CIRB plan. When the number of member hospitals increases markedly, the methods of reviewing “local issues” should be reconsidered in order to safeguard the rights, safety, and well-being of trial subjects. (Jpn J Clin Pharmacol Ther 2013; 44(3): 207-215)
世界の医薬品開発においてアカデミア・スタートアップによる開発が主流となっている。その中で日本が取り残されている。あなたは以下の質問に答えられますか？Q1.なぜスタートアップによる開発が主流となっているのか？ ...リスクマネーって何？Q2.技術移転や民間からの資金調達に必要な要素は何？Q3.グローバル展開における市場やヘルスケアシステムの各国の違いを理解していますか？Q4.開発計画に加え、事業計画の策定、資金調達の計画が必要となります。あなたは資本政策についてご存じですか？Q5.事業計画を構築する上で、以下の検討を行います。あなたはこれらを説明できますか？ Value proposition、Competitive landscape、Patient journey、Business Model Canvas、SOM／SAM／TAMResearch Studioでは、これらについて、各界のトップリーダーによるメンタリングと橋渡し研究や医学の専門家による伴走支援を通じて、標的とするCustomer／疾患セグメントの特定から出口戦略まで、順を追って構築していく。UC San Diegoでの１週間の海外研修では、KOLやVCとの面談や米国におけるパートナーの探索も行うなど大変贅沢なプログラムになっている。2018年に大学関連携によりプログラムを開始し、すでに多くの実績を上げている。具体的には、過去5年間で29チームが参加し、14チームが資金調達に成功し、その総額は78億円となり、2チームが治験を開始し、12チームが非臨床POCを達成している。このプログラムでは、スタートアップの実践的育成を通じて、各大学のAROで指導する教職員の育成も行なっている。また、プログラム修了生のアルムナイの会も形成している。これらの実績と横のつながりがエコシステム形成につながっていくものと考えている。
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