内容紹介
Summary
Patient participation is defined as incorporation of opinions by patients and citizens when clinical trials are planning. It has been early established in the USA and the UK. The Japan Clinical Oncology Group(JCOG)has recently launched a subcommittee of patient participation and has tried to input opinions of patients and citizens in clinical trials. We, Hepatobiliary and Pancreatic Oncology Group in JCOG, has held 3 meetings of patient participation for 3 years. We introduced our policy and clinical trials and discussed off-label drugs or treatments. In the third meeting in 2019, we have discussed precision medicine using genome analysis and clinical trials which are currently planning in our group. There are some significances and expectations to patient participation from the points of views of researchers. It is meaning to pick up clinical unmet medical needs from patient participation and input requests and opinions of patients to a protocol. Opinions of patients and citizens may be useful to make informed consent form easy to read and understand for patients and their family. In order to accelerate recruitment of patients in clinical trials, it is important that patients and citizens understand exactly clinical trials through patient participation. Patient participation has just begun in Japan. It is expected to establish Japanese patient participation in the near future. It is important for not only researchers but also patients to obtain some benefits from patient participation.
要旨
臨床試験の立案において米国や英国では早くから患者・市民の意見を取り入れる,いわゆる患者・市民参画が確立している。日本臨床腫瘍研究グループ(JCOG)でも患者参画小委員会を立ち上げ,患者・市民の意見を参考とした臨床試験の実施を検討しはじめている。JCOG肝胆膵グループでは3年前より患者参画意見交換会を実施し,グループの紹介,未承認・適応外薬に対する要望,がんゲノム医療について計画中の臨床試験への意見などをテーマに実施してきた。研究者側からみた患者参画に対する意義や期待として,臨床試験を行うべき臨床的課題の探索,臨床試験のコンセプト作成段階で患者の視点から意見や要望を取り入れる,説明文書のわかりやすい作成,患者・市民の臨床試験への理解による患者登録の促進などがあげられる。患者参画の取り組みはまだ始まったばかりであり,日本型の患者参画の確立が期待される。患者参画を継続するには研究者と患者・市民の双方の利益につながる患者参画が必要と考えられる。
目次
Patient participation is defined as incorporation of opinions by patients and citizens when clinical trials are planning. It has been early established in the USA and the UK. The Japan Clinical Oncology Group(JCOG)has recently launched a subcommittee of patient participation and has tried to input opinions of patients and citizens in clinical trials. We, Hepatobiliary and Pancreatic Oncology Group in JCOG, has held 3 meetings of patient participation for 3 years. We introduced our policy and clinical trials and discussed off-label drugs or treatments. In the third meeting in 2019, we have discussed precision medicine using genome analysis and clinical trials which are currently planning in our group. There are some significances and expectations to patient participation from the points of views of researchers. It is meaning to pick up clinical unmet medical needs from patient participation and input requests and opinions of patients to a protocol. Opinions of patients and citizens may be useful to make informed consent form easy to read and understand for patients and their family. In order to accelerate recruitment of patients in clinical trials, it is important that patients and citizens understand exactly clinical trials through patient participation. Patient participation has just begun in Japan. It is expected to establish Japanese patient participation in the near future. It is important for not only researchers but also patients to obtain some benefits from patient participation.
要旨
臨床試験の立案において米国や英国では早くから患者・市民の意見を取り入れる,いわゆる患者・市民参画が確立している。日本臨床腫瘍研究グループ(JCOG)でも患者参画小委員会を立ち上げ,患者・市民の意見を参考とした臨床試験の実施を検討しはじめている。JCOG肝胆膵グループでは3年前より患者参画意見交換会を実施し,グループの紹介,未承認・適応外薬に対する要望,がんゲノム医療について計画中の臨床試験への意見などをテーマに実施してきた。研究者側からみた患者参画に対する意義や期待として,臨床試験を行うべき臨床的課題の探索,臨床試験のコンセプト作成段階で患者の視点から意見や要望を取り入れる,説明文書のわかりやすい作成,患者・市民の臨床試験への理解による患者登録の促進などがあげられる。患者参画の取り組みはまだ始まったばかりであり,日本型の患者参画の確立が期待される。患者参画を継続するには研究者と患者・市民の双方の利益につながる患者参画が必要と考えられる。