Madeira C, Pais A, Kubiak C, Demotes J, Monteiro E C
Portuguese Clinical Research Infrastructure Network (PtCRIN), Lisbon, Portugal.
European Clinical Research Infrastructure Network (ECRIN), Paris, France.
Contemp Clin Trials Commun. 2016 Aug 20;4:141-148. doi: 10.1016/j.conctc.2016.08.002. eCollection 2016 Dec 15.
Interventional clinical studies can provide the highest levels of evidence and generate significant results on specific investigational medicinal products or medical devices. In order to have powerful studies, attain unquestionable results and make significant discoveries, the number of patients enrolled must be high. Therefore, multinational, randomised clinical trials are necessary. The multicentre, multinational recruitment of subjects in investigator-initiated clinical trials (IICTs) increases their logistical burden, justifying the need for specific infrastructures to ease implementation. Herein, we provide for the first time an overview of the facts and figures concerning IICTs, existing infrastructures' capacity for interventional clinical research, and scientific performance of investigators in a European country, Portugal. We aim to highlight the relevance and need for investing in European infrastructures such as the European Clinical Research Infrastructure Network (ECRIN) for multinational IICTs. A public, non-profit organisation, ECRIN facilitates the conduct of multinational clinical trials in Europe by coordinating scientific partners and their networks, and providing advice, management services and tools to enhance collaboration. Currently in Portugal, few multinational randomised IICTs are coordinated by national investigators. This is most likely due to the lack of human resources dedicated to clinical trials in clinical research centres (CRCs) as well as the scarcity of professional academic clinical trial units (CTUs) providing logistics and management services at non-profit rates. With the data shown, we expect to trigger the development of similar studies in other European countries and stress the impact of government support for IICTs.
干预性临床研究能够提供最高级别的证据，并就特定的研究用药品或医疗器械产生显著成果。为了开展有力的研究、获得确凿的结果并做出重大发现，纳入的患者数量必须足够多。因此，跨国随机临床试验是必要的。在研究者发起的临床试验（IICTs）中，多中心、跨国招募受试者增加了后勤负担，这就证明需要有特定的基础设施来便于实施。在此，我们首次概述了有关葡萄牙这个欧洲国家的IICTs、现有基础设施开展干预性临床研究的能力以及研究者的科研表现的事实和数据。我们旨在强调投资于欧洲临床研究基础设施网络（ECRIN）等欧洲基础设施以开展跨国IICTs的相关性和必要性。ECRIN是一个公共非营利组织，通过协调科学合作伙伴及其网络，并提供建议、管理服务和工具以加强合作，促进在欧洲开展跨国临床试验。目前在葡萄牙，很少有跨国随机IICTs由本国研究者协调开展。这很可能是由于临床研究中心（CRC）缺乏专门用于临床试验的人力资源，以及缺乏以非营利价格提供后勤和管理服务的专业学术临床试验单位（CTU）。通过所展示的数据，我们期望引发其他欧洲国家开展类似研究，并强调政府对IICTs支持的影响。
