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Off-label use of medicines between clinical research and practice
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
A similar arrangement applies in post-Brexit UK. The EU Clinical Trials Directive has already been implemented in the UK by the Clinical Trials Regulations.76 These continue to apply after Brexit. Indeed, Section 2(1) of the European Union (Withdrawal) Act 2018 clarifies that “EU-derived domestic legislation as it has effect in domestic law immediately before exit day, continues to have effect in domestic law on and after exit day”. Conversely, the incoming CTR has not been incorporated into UK domestic law. Indeed, under Section 3(1) of the European Union (Withdrawal) Act 2018, as amended by the European Union (Withdrawal) Act 2020, direct EU legislation, for example, regulations, forms part of domestic law on and after the implementation period (IP) completion day (i.e., 31 December 2020) if “operative” immediately before IP completion day. As regards the acts coming into force at a particular time and stated to apply later, any direct EU legislation is “operative” immediately before IP completion day if it is “in force” and “applies” before such a day (Section 3(3)(a) of European Union (Withdrawal) Act 2018, as amended by the European Union (Withdrawal) Act 2020). This excludes the CTR from incorporation into domestic law. Indeed, on IP completion day, the CTR was already in force but still not applicable.
Conduct of an inquiry into alleged misconduct
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
The introduction throughout Europe of the Clinical Trials Directive3 means that the conduct of clinical trials involving medicinal products must, by law, be in accordance with Good Clinical Practice (GCP). It further means that anybody making any false declaration in a submission to an ethics committee or in an application to carry out a clinical trial is guilty of a criminal offence. Strangely, it does not mean that someone fabricating data is automatically similarly guilty.
Medical research
Published in Marc Stauch, Kay Wheat, Text, Cases and Materials on Medical Law and Ethics, 2018
Until relatively recently, medical research has been subject to the common law, and clinical trials have been subject to the Medicines Act 1968. However, the enactment of the European Clinical Trials Directive 2001/20 EC prompted the government to issue regulations to govern the conduct of clinical trials. Not all research, however, is concerned with the investigation of medicinal products and research that lies outside this ambit will still be governed by a mixture of the common law, any constraints imposed by ethics committees, and any quasi-statutory guidance from the relevant bodies (see below).
Comparison of nine platelet function tests used to determine responses to different aspirin dosages in people with type 2 diabetes
Published in Platelets, 2019
Paul Harrison, M. Angelyn Bethel, Irene Kennedy, Robert Dinsdale, Ruth Coleman, Rury R. Holman
This investigator-led, single-center, randomized, prospective, double-blind study received ethical approval from the South East London Research Ethics Committee 3 (15). It complied with The World Medical Association Declaration of Helsinki (1964) and its amendments and clarifications, the European Union Clinical Trials Directive (2001/20/EC), and International Conference on Harmonization Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95). All participants provided written informed consent. The authors are solely responsible for the design, conduct, and analysis of this study, the drafting and editing of the manuscript, and its final contents.
A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch
Published in Current Medical Research and Opinion, 2021
Several authors have suggested various definitions of RWE, some of which differ materially. In this study, RWE is the scientific knowledge generated on the level of the individual outside the confines of the clinical trials directive, answering research questions in a more generalised, real-world patient population11. Similarly, the expected effects of arriving at launch of a new medicine with RWE in addition to RCTE was defined as: an increase in the depth of maximal adoption and reduction in the time to maximal adoption, compared to a reference for RCTE alone.