Marchesi Emanuela, Monti Manuela, Nanni Oriana, Bassi Lisette, Piccinni-Leopardi Martina, Cagnazzo Celeste
1 Scientific Direction, Rizzoli Orthopedic Institute, Bologna - Italy.
2 Italian Sarcoma Group, Bologna - Italy.
Tumori. 2018 Jan-Feb;104(1):15-21. doi: 10.5301/tj.5000668.
In 2015, the Italian Medicines Agency (Agenzia Italiana del Farmaco; AIFA) issued the Determination 809/2015 with new requirements for phase I clinical trials. Before it came into force, we explored the extent to which several Italian oncology centers were working to implement it.
A survey was conducted among 80 Italian centers involved in clinical trials. Investigators and research coordinators were surveyed.
Answers from 42 institutions were collected: among them 88.1% were involved in oncology research. In the last 5 years, 55% had conducted from 1 to 5 phase I trials, and only 16.7% more than 5. A third were involved in not-first-in-human research and none with healthy volunteers. The majority (57.1%) of the centers did not run any projects and trials are non-commercial, and about 35%, no more than 2. While 9.5% already met the standards for self-certification, 71.4% were working to achieve them. Standard operating procedures dedicated to research and the required good clinical practice training had been established by 57.1% and 76.2%, respectively. Fifty percent of laboratories were almost compliant with the Determination. After 10 months from its coming into force, 98 sites had applied for certification, of which 34 were oncology units.
The new AIFA Determination imposes a certified organizational model on units and laboratories involved in phase I trials. Our results showed that great efforts were made to qualify for phase I research suggesting that other oncology units will apply for certification in the near future. Predictably, Italy will set the pace as a highly qualified country in which to conduct early-phase research.
2015年，意大利药品管理局（Agenzia Italiana del Farmaco；AIFA）发布了第809/2015号决定，对I期临床试验提出了新要求。在该决定生效之前，我们探究了几家意大利肿瘤中心为实施该决定所做的努力程度。
对80家参与临床试验的意大利中心进行了一项调查。对研究人员和研究协调员进行了调查。
收集了42家机构的回复：其中88.1%参与了肿瘤学研究。在过去5年中，55%的机构开展了1至5项I期试验，只有16.7%的机构开展了5项以上。三分之一的机构参与了非首次人体研究，没有机构涉及健康志愿者研究。大多数中心（57.1%）没有开展任何项目，试验均为非商业性的，约35%的中心开展项目不超过2个。虽然9.5%的中心已经达到了自我认证标准，但71.4%的中心正在努力实现这些标准。分别有57.1%和76.2%的中心制定了专门用于研究的标准操作规程和所需的良好临床实践培训。50%的实验室几乎符合该决定的要求。该决定生效10个月后，有98个机构申请认证，其中34个是肿瘤科室。
AIFA的新决定对参与I期试验的单位和实验室强加了一个经过认证的组织模式。我们的结果表明，各机构为符合I期研究标准付出了巨大努力，这表明其他肿瘤科室将在不久的将来申请认证。可以预见，意大利将成为开展早期研究的高资质国家并引领潮流。
