ArticleContemporary clinical trials communications2018
Main changes in European Clinical Trials Regulation (No 536/2014).
Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Evaluation of the awareness of novel advanced therapies among family medicine residents in Spain.PloS one · 2019Trial
- From Traditional Use to Molecular Mechanisms: A Bioinformatic and Pharmacological Review of the GenusBiotech (Basel (Switzerland)) · 2025Review
- Leveraging Large Language Models for High-Quality Lay Summaries: Efficacy of ChatGPT-4 with Custom Prompts in a Consecutive Series of Prostate Cancer Manuscripts.Current oncology (Toronto, Ont.) · 2025Article
- Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model.BMJ open · 2024Review
- Design of a pragmatic randomized implementation effectiveness trial testing a health system wide hypertension program for older adults.Contemporary clinical trials · 2024Article
- Clinical trials.European journal of hospital pharmacy : science and practice · 2024Article
- Article
- Design a Clinical Research Protocol: Influence of Real-World Setting.Healthcare (Basel, Switzerland) · 2023Review
- Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities.Contemporary clinical trials communications · 2022Article
- Ethical Considerations in Clinical Trials for Disorders of Consciousness.Brain sciences · 2022Article
- Challenges and opportunities for Multi-National Investigator-Initiated clinical trials for ALS: European and United States collaborations.Amyotrophic lateral sclerosis & frontotemporal degeneration · 2021Article
- Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries.Epidemiology and psychiatric sciences · 2020Article
- Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie · 2020Article
- Article
- The new Regulation on clinical trials in relation to radiopharmaceuticals: when and how will it be implemented?EJNMMI radiopharmacy and chemistry · 2019Article
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 new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human is part of a European regulatory framework in which the European Commission has wished to give a strong impetus to scientific research and industrial progress. It is a new regulation that fills a series of regulatory gaps in the Clinical Trials through the creation of a uniform framework for the authorization of clinical trials by all interested Member States with a single assessment of the results. The Regulation thus facilitates cross-border cooperation to make the clinical tests wider and encourage the development of special treatments, for example for rare diseases, but above all streamlines the rules on clinical trials across European Union (EU), introducing simplified rules for experimentation so-called 'low level of intervention', on which much has been discussed and still arouses concern, providing for authorized medicines or used off-label in the presence of scientific evidence published on efficacy and safety and to benefit from they will be mainly the pediatric and oncological therapeutic areas. The applications and any communication will be submitted paperlessly via a new electronic EU portal. The complex processing procedures and shorter time limits are to be stressed in comparison to the previously valid regulations. This is a major challenge for all stakeholders, but on the other hand it should contribute to the future role of the EU in the development of innovative medicines.
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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.