FSP (Functional Service Provision) is fairly common in the United States and Europe, where many of the world’s leading pharmaceutical and biotechnology companies are located, but the term ‘FSP’ is not yet commonplace in Japan. Furthermore, FSP is not ‘mainstream’ in China either. Japanese-based pharmaceutical companies, including foreign companies, are mainly utilising a more orthodox model of outsourced services (more commonly known as a ‘Full-Service Model’). In Japan, in-house statisticians often create statistical analysis plans and protocol statistics sections and only outsource the programming elements of their statistics-related work. In addition to this, there are many temporary staffing companies which provide personnel to companies to support their daily programming work. The US and Europe also oftentimes operate an “enhanced FSP” – building teams of high calibre technical expertise and experience, working under the direction of a technical lead.
In Europe and the United States, FSP is already well known and well utilized. In Japan, the workforce landscape is markedly different – it is difficult to hire experienced statisticians and analysis programmers’ who are mid-career, it’s difficult to dismiss full-time employees in Japan, and it is difficult to secure hiring quotas for full-time employees. In the future, it will be possible to respond more flexibly than dispatching, as the work of clinical testing and statistical / analysis programming becomes more complicated and specialized, awareness, benefits and demand of FSP will gradually increase.
In Japan, it is difficult for pharmaceutical and biotechnology companies with small development departments to hire statisticians and retain personnel – in many cases, there are no programmer hiring quotas in the first place. In such cases, utilising FSP can allow them to effectively staff their trials with experienced, proficient personnel.
If a company chooses to outsource, they have the ability to manage the vendors, including acceptance checks for statisticians and programmers. In Europe and the United States, FSP personnel are used largely to provide specialized services, and therefore have the same or higher knowledge and responsibilities as ‘in-house’ employees. These quality, technical experts bolster and support the specialized knowledge and experience within the company, as opposed to just undertake basic tasks. Even in a pharmaceutical company with a large development department, there are ebbs and flows in development items and workload, and if it is difficult to increase the hiring quota for full-time employees because of a temporary spike in workload, or if the hiring of retirees does not proceed, FSP is the perfect solution. There is a demand for FSP statisticians and programmers who can use services and not hire full-time employees to provide professional services equal to or better than full-time employees.
In recent years, clinical trials have been developed globally, and it has become common for Japanese personnel to prepare statistical analysis plans and CDISC-related documents in English. In addition to documents, it is becoming a daily sight for many companies to communicate with overseas personnel in English. It is not uncommon for major Japanese pharmaceutical companies to have their development departments headquartered in the United States and the global head of statistics departments in the United States. In Europe and the United States, where there are many universities and graduate schools that teach statistics and biostatistics, there are a large number of statisticians and programmers, so there are companies in which the size of the statistics department in Europe and the United States is overwhelmingly larger than that in Japan, where the head office is located. The importance of data analysis is increasing, and the reality is that many companies rely on overseas human resources, not just the supply of statisticians and analysis programmers in Japan. In the future, statisticians and programmers in Japan will be required to have more English proficiency as the number of clinical trials in Japan increases, and even though they are in Japan, they will use FSP services to collaborate with highly specialized statisticians and analysis programmers overseas. It is expected that we will be able to respond to the needs of clinical trials and carry out our work efficiently.
Translation
FSPが日本でどのように効率と品質を向上させることができるか
多くの医薬品メーカーやバイオベンチャーのあるアメリカやヨーロッパではFSP (Functional Service Provision)はかなり一般的ですが、日本ではFSPという言葉はまだあまり一般的ではないかもしれまんせん。中国でもFSPは主流ではありません。外資を含む日本に拠点をおいている製薬会社は主にオーソドックスな外注サービスのモデル(Full Service Model)をを利用しています。日本では統計関連の業務は社内の統計家が統計解析計画書やプロトコルの統計のセクションを作成し、プログラミングのみ外注をする事も多々あります。また、プログラミングに関しては派遣会社の社員にオフィスに常駐してもらい、日々のプログラミング業務をサポートしてもらう会社も多いのが現状です。米国とヨーロッパは、しばしば「強化されたFSP」を運用します。これは、技術リーダーの指示の下で作業する、高度な技術的専門知識と経験のチームを構築することです。
欧米ではFSPは既にメインストリームであること、経験豊富な統計家や解析プログラマーの中途採用が難しいこと、日本では正社員の解雇が難しく正社員の採用枠を確保しにくいこと、派遣会社を通じてのプログラマーの常駐派遣よりも更に柔軟に対応できること、また臨床試験、統計・解析プログラミングの仕事が専門家し複雑化するなかで日本でも少しづつFSPの認知度が上がり需要も増えていくのではないかと思います。
日本で開発部門の小さい製薬会社やバイオベンチャーだと統計家の採用や人材の定着が難しかったり、そもそもプログラマーの採用枠がなかったりする場合も多いのが実情です。その様な場合はFSPサービスを使い、外注しないで社内で業務を行う場合は試験をリードできるFSPの統計家やプログラマー、外注に出す場合は受け入れチェック等ベンダーのマネージメントができるFSPの統計家やプログラマーがサポートできます。欧米でFSPへの期待は専門性のサービス提供という面が大きいので、単純作業よりもこうした社内で専門的な知識や経験を補強のため社員と同等以上の期待と責任を負うこともしばしばあります。大きな開発部門をもつ製薬会社でも開発品目と業務量には波があり、一時的に忙しくなるからと正社員の採用枠を増やすこは難しかったり、退職者の採用が進まなかったりする場合はFSPのサービスを使い正社員を採用せず、正社員と同等以上の専門的なサービスを提供できるFSPの統計家やプログラマーの需要はあるでしょう。
昨今の臨床試験はグローバルの開発が進み、日本の担当者も英語で統計解析計画書やCDISC関連の書類を作成することが一般的になってきました。書類だけでなく、多くの会社では海外の担当者と英語でやり取りするのも日常の光景になってきています。日本の大手製薬会社も開発部門の本社はアメリカにあり、統計部門のグローバルの責任者もアメリカにいるとういうことが珍しくはありません。統計学や生物統計学を教える大学・大学院も多い欧米は統計家やプログラマーの層も厚いので、本社のある日本の統計部門より欧米の統計部門の規模の方が圧倒的に大きい会社もあります。データ解析の重要性もますます向上し、日本にいる統計家や解析プログラマーだけでは供給だけでは足りず、海外の人材に頼っている会社も多いのが実情です。今後は日本国内の統計家やプログラマーもグローバルの治験の増加とともにますます英語力を求められるようになり、日本に居ながらもFSPサービスを使い海外の専門性の高い統計家や解析プログラマーと共同し臨床試験のニーズに対応し、効率よく業務を遂行することが進んでいくものと思われます。