Impact of the New European Regulation on Clinical Trials in the Activity of Research Ethics Committees from Catalonia (Spain)

被引：0

作者：

Redondo-Capafons, Susana ^{[1
,2
]}

Quintana, Salvador ^{[2
]}

March-Lopez, Pablo ^{[1
]}

Nicolas, Jordi ^{[2
]}

Cassany-Pou, Salvador ^{[3
]}

Marti-Guixa, Teresa ^{[3
]}

Fernandez-Lastra, Cecilia ^{[4
]}

Marino, Eduardo L. ^{[4
]}

机构：

[1] Hosp Univ Mutua Terrassa, Pharm Dept, Terrassa, Barcelona, Spain

[2] Hosp Univ Mutua Terrassa, Res Eth Comm, Terrassa, Barcelona, Spain

[3] Generalitat Catalunya, Hlth Dept, Pharmaceut Control & Prod Serv, Barcelona, Spain

[4] Univ Barcelona, Fac Pharm & Food Sci, Clin Pharm & Pharmacotherapy Unit, Dept Pharm & Pharmaceut Technol & Phys Chem, Barcelona, Spain

来源：

LATIN AMERICAN JOURNAL OF PHARMACY | 2021年 / 40卷 / 01期

关键词：

clinical trials; legislation; Research Ethics Committee;

D O I：

暂无

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Different legislations have regulated Clinical Trials (CT) in Spain. The last European regulations have substantially impacted on the Research Ethics Committees (RECs), especially the latter, Regulation (EU) No536/2014. Spain was the first European country to apply this new regulation, so the aim of this study was to analyze its impact on the activity of RECs from Catalonia, comparing it with previous legislation. Annual activity reports (number of meetings and CTs evaluated) were analyzed. Two periods (coinciding with different legislations) were established. Kruskal-Wallis and MANOVA factor tests were used (p < 0.05). 420 reports from 47 RECs were reviewed. There were no changes in number of meetings (p = 0.329), but a sharp decrease in number of CT evaluations was observed in second period (p < 0.001). In conclusion, new legislation has had an impact on Catalan RECs. The number of evaluation activities have shown fluctuations over years, but the decrease has become more evident nowadays.

引用

页码：16 / 21

页数：6

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