European Clinical Research Infrastructure Network (ECRIN), Paris, France.
Portuguese Clinical Research Infrastructure Network (PtCRIN), Lisbon, Portugal.
Ther Innov Regul Sci. 2021 Sep;55(5):966-978. doi: 10.1007/s43441-021-00293-w. Epub 2021 May 18.
Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes.
A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed.
IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs' publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%).
The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.
临床试验提供了支持医疗实践的最高证据水平之一。研究者发起的临床试验（IICTs）回答了临床实践中可能未被行业解决的相关问题。这是第一次对两个欧洲国家的 IICTs、各自的资助者和出版物进行比较，旨在启发其他国家使用类似的指标来评估临床研究结果。
对来自两个具有相似人口、国内生产总值、人类发展指数和医学院的欧洲国家的 2004 年至 2017 年注册的 IICT 进行了回顾性系统检索，使用了四个临床试验登记处。每个 IICT 都根据赞助商、资助者、干预类型和已完成的相关出版物进行了筛选。
涉及捷克共和国和葡萄牙的 IICT 分别为 n=439（42%的赞助商为医院）和 n=328（47%的赞助商为大学）。捷克共和国和葡萄牙的资助机构分别支持了 61 项和 27 项 IICT。其中，捷克共和国的试验药物占 52%，葡萄牙仅占 4%。在第一个国家，具有国家研究者作为作者的高影响力因子期刊上发表的 IICT 出版物比例更高，与葡萄牙相比（75%比 15%）。
捷克共和国在临床研究方面的更好表现可能与对临床研究的特定和定期资助有关，尽管仍需要进一步的数据来证实这种关系。在未来几年，本文使用的指标可能对跟踪这些和其他欧洲国家的临床研究结果有用。
