ArticleScience and engineering ethics2016
Clinical Trial Application in Europe: What Will Change with the New Regulation?
Article in Science and engineering ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- PedCRIN tool for the biosamples management in pediatric clinical trials.Clinical and translational science · 2023Article
- Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.Reviews on recent clinical trials · 2023Article
- Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries.International journal of environmental research and public health · 2022Article
- Informed consent and assent guide for paediatric clinical trials in Europe.Archives of disease in childhood · 2022Article
- Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency.Acta bio-medica : Atenei Parmensis · 2022Article
- Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study.Clinical trials (London, England) · 2022Article
- Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project.BMC medical ethics · 2021Article
- Article
- Ethics committees for clinical experimentation at international level with a focus on Italy.Acta bio-medica : Atenei Parmensis · 2020Review
- Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.BMC medical ethics · 2019Article
- The ethical framework for performing research with rare inherited neurometabolic disease patients.European journal of pediatrics · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC?
Indexed as
Identifiers
26037896What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.