Can Maternal Spindle Transfer and Pronuclear Transfer Be Prohibited under eu Legislation?

2018 ◽  
Vol 25 (1) ◽  
pp. 57-74 ◽  
Author(s):  
Calum MacKellar
Keyword(s):  
Clinical Trials ◽  
Medicinal Product ◽  
Germ Line ◽  
Genetic Identity ◽  
Medical Procedure ◽  
Eu Legislation ◽  
Human Fertilisation ◽  
Mitochondrial Donation ◽  
Maternal Spindle Transfer ◽  
Pronuclear Transfer

Abstract The question whether maternal spindle transfer (mst) and pronuclear transfer (pnt) can be prohibited under eu legislation was examined by the non-governmental organisation European Bioethics Research (ebr). It did so by submitting an official complaint to the eu Commission proposing that the uk Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 breached the prohibition on the modification of a person’s germ line genetic identity of the eu Clinical Trials Directive 2001/20/EC and the new Regulation eu 536/2014. A discussion then took place, during 2016, between ebr and the eu Commission whether mst and pnt principally involved a ‘medicinal product’ in which case the eu Clinical Trials Directive 2001/20/EC and Regulation eu 536/2014 would be applicable or whether the procedures just involved a medical procedure in which case the Tissue and Cells Directive 2004/23/EC was applicable which did not include any prohibition on the intentional modification of a person’s germline.

Pharmaceutical Law and Patent Law

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Carlo A. Piria ◽  
Carlo A. Piria
Keyword(s):  
Clinical Trials ◽  
Medicinal Product ◽  
Legal System ◽  
Active Substance ◽  
Patent Law ◽  
Efficacy And Safety ◽  
Patent Claim ◽  
Laws And Regulations

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.

Moving next-generation sequencing into the clinical realm: Detection of somatic mutations in cancer by targeted amplicon sequencing.

2012 ◽  
Vol 30 (30_suppl) ◽  
pp. 60-60
Author(s):  
Chih-Jian Lih ◽  
Thomas Forbes ◽  
Michele Mehaffey ◽  
Eric Sause ◽  
David Sims ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Next Generation Sequencing ◽  
Cancer Patients ◽  
Patient Selection ◽  
Somatic Mutations ◽  
Germ Line ◽  
Early Stage ◽  
Illumina Miseq ◽  
Next Generation ◽  
Generation Sequencing

60 Background: Molecular targeted therapies are increasingly important in treating cancer patients; robust analytically validated clinical assays are required for patient selection in early-stage clinical trials. The goal of Molecular Characterization Laboratory (MoCha) is to develop clinical diagnostic assays using next generation sequencing methods to support clinical studies in DCTD (CTEP). Methods: We developed a custom assay for somatic mutation detection using Fluidigm access array technology for amplicon generation followed by sequencing with the Illumina Miseq. A panel of 62 amplicons covering 6 Kb genomic regions was designed to detect 92 DNA loci, including common therapeutically actionable targets, in 37 genes. Analytical studies were performed using genomic DNA samples from fresh or formalin fixed cancer cell-lines and a normal hapmap individual (CEPH). We subsequently applied this assay to characterize DNA samples from both tumor tissues and blood specimens from ovarian cancer patients. Results: The assay detected known variants in both frozen and fixed DNA samples reproducibly with high sensitivity and specificity (<2%). Using a series of positive control plasmid spikes mixed into a normal reference CEPH DNA at pre-defined copy number ratios, we verified the assay is sensitive to detect variants at 5% allelic frequency with a minimum 400 X coverage. We identified somatic mutations in TP53 and PIK3CA in a few patients, and a germ-line variant D1583N in ATM genes occurring in one-third of tested patients. Conclusions: We developed and validated a next generation sequencing assay suitable for patient selection for clinical trials. Plans are to correlate sequencing and clinical results when clinical data are available.

scholarly journals EU legislation threatens clinical trials

BMJ ◽  
2003 ◽  
Vol 326 (7403) ◽  
pp. 1348-a-1348 ◽  
Author(s):  
R. Watson
Keyword(s):  
Clinical Trials ◽  
Eu Legislation

scholarly journals Unapproved clinical trials in Russia: exception or norm?

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Petr Talantov ◽  
Ravil Niyazov ◽  
Galina Viryasova ◽  
Margarita Dranitsyna ◽  
Ilya Yasny
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medicinal Product ◽  
Clinical Investigation ◽  
Randomised Trial ◽  
Well Being ◽  
Russian Language ◽  
Full Description ◽  
Medical Journals ◽  
Administration Method

Abstract Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common practice. Methods We searched the Russian language database eLIBRARY for the phrase ‘results of a randomised trial’. We selected publications reporting clinical trials and conducted in Russia. For each of the selected studies, we searched the state register of the approved clinical trials. We assessed whether (1) the investigational medicinal product was approved for marketing in Russia; (2) the therapeutic indications, posology, and administration method in the clinical trial were consistent with the approved labelling; (3) the issue of the journal included an advertisement of the medicinal product in question; and (4) the full description of the methodology corroborated that the clinical trial was randomised, as was stated in the title or abstract. Results Of the 26 selected articles, 22 reported the results of unauthorised clinical trials. Three of those trials were conducted in children. Twenty-one studies reported on data from unauthorised trials for investigational products approved for marketing in Russia. However, in nine cases, the therapeutic indications, posology, or administration method did not match the conditions indicated in the labelling. Moreover, in one case, the unauthorised trial included a drug therapy intervention where the active substance was not approved for use in any medicinal product marketed in Russia. In 14 of the 26 articles, the issue of the journal or the article itself contained an advertisement for the same medicinal product or, in one case, its manufacturer. All publications accompanied by advertisements claimed that the medicinal product in question was efficacious. Conclusions A substantial fraction of the clinical trials initiated by domestic sponsors and reported in Russian medical journals failed to obtain the mandatory prior evaluation and approval from the regulator. This can affect the rights and well-being of the study participants and the scientific validity of the studies.

scholarly journals The informed consent in clinical trials in school dental units: Impact analysis

2017 ◽  
Vol 63 (3) ◽  
pp. 111-114
Author(s):  
Cristian Funieru ◽  
◽  
Ruxandra Ionela Sfeatcu ◽  
Silviu Mirel Piţuru ◽  
◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Oral Health ◽  
Impact Analysis ◽  
Oral Health Status ◽  
Medical Procedure ◽  
Consent Forms ◽  
Dental Clinics ◽  
Sterilization Process

Introduction. The informed consent is a very important and needful issue for any medical procedure, treatment or clinical trial. In case of minor patients or those without capacity of discernment, the legal owners must sign the informed consent. Materials and methods. The present study is an analysis of the informed consent forms used in 3 studies conducted between 2006 and 2016 in the schools dental units in Bucharest, which had as main objective the examination of the oral health status of schoolchildren aged between 11 and 14 years, as well as many various correlations related to it. Results. The parents approved (69%), refused (17%) their children being part of these studies and others put some conditions. The main reason for the parents’ refusal regarding the clinical trials was the lack of confidence in dental tools’ sterilization process. Conclusions. The informed consent has some limits when dealing with minor patients. It is very important for school dentists, for those who work in private dental clinics or for the examiners in clinical trials that parents always sign the informed consent.

Clinical Trials Regulation: A Further Step towards Increased Medical Innovation in the EU

2015 ◽  
Vol 6 (4) ◽  
pp. 646-648
Author(s):  
Anna Pavlou ◽  
Emmanuel Saurat
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
European Commission ◽  
Well Being ◽  
Medical Innovation ◽  
Eu Legislation ◽  
Clinical Trials Regulation ◽  
Clinical Trial Activity ◽  
Law Making ◽  
The Eu

On 27 May 2014, after two years of debates and extensive amendments by the EU’s law-making institutions, the EU Clinical Trial Regulation1 was published. The Regulation repeals and replaces the Clinical Trials Directive, an instrument described by the European Commission as “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”. The Clinical Trials Regulation is intended to improve the existing framework, and will become applicable at the earliest on 28 May 2016. This report reviews the most significant changes to the existing system brought about by the Clinical Trials Regulation, and how this Regulation purports to strike a balance between its objective of increasing clinical trial activity in the EU and the need to protect clinical trial subjects’ rights, safety and well-being.

scholarly journals The research of tolerance of solution for intrauterus application “Yodozol”

2019 ◽  
Vol 21 (94) ◽  
pp. 15-19
Author(s):  
R. M. Sachuk ◽  
O. A. Katsaraba ◽  
Ya. S. Stravsky ◽  
S. V. Zhigalyuk
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Medicinal Product ◽  
Functional State ◽  
Physiological State ◽  
Negative Influence ◽  
Medical Product ◽  
The Body ◽  
Clinical State ◽  
Service Period

Complex clinical trials have been carried out in order to study the tolerance and detail of the effect on the morpho-functional state of the organism of target animals of the new development of PE “Biopharm” and the Experimental Station of Epizootology IVM NAAS – solution for intrauterus use in the form of aerosol “Yodozol”, which will help predict the appearance of side effects from drug and prevent it. Methods of evaluation of a medicinal product for clinical trials, including for determining tolerance limits, which were used, included: the determination of the general clinical state of the organism, the study of hematological and biochemical parameters of blood, the control of the age of their first calving and service period, as well as statistical (calculation of average values and error of experimental data). “Yodozol” is a light yellow liquid, 1 ml of which contains 5 mg of iodine and 10 mg of potassium iodide. The drug is used for the prophylaxis and treatment of postpartum intrauterine infections in cows, pigs, sheep and goats (endometritis, pyrometers, cervicitis, vaginitis, delayed digestion caused by microorganisms sensitive to iodine), after giving rhombus, cesarean section and postpartum sanitation of the uterus. Medical product possesses antimicrobial, anti-inflammatory and analgesic actions, improves proliferative processes of genital organs, reduces the time of recovery of animals. The drug is used in accordance with the guidelines, after which livestock products are used without restriction. It has been established that the new medicinal product “Yodozol” with three times intrauterine application of cattle at intervals of 48 hours in doses that 2–10 times exceeds the recommended therapeutic, is tolerant. The excess amount of the drug does not cause significant side effects when injected into the uterus. There was no negative influence on the general clinical condition of cows and changes in the morpho-functional state of their organism. Three animals had an increase in the volume of the uterus, omission of horns and the body of the uterus. However, this is a normal individual physiological local reaction of the body to the introduction of an increased amount of foreign matter, which does not affect the general physiological state of animals. The volume and physiological placement of the uterus independently came to normal after the discontinuation of the drug. In all experimental animals exposed to different doses of the iodosol drug, the age of their first calving was from 29.0 ± 1.87 to 33.7 ± 2.27 months, the service period from 76.3 ± 2.27 to 81.0 ± 0.71 days, fluctuating within the limits of physiological norms. All conducted studies of the tolerance of the solution for intrauterine application “Yodozol” were included in the registration materials of the medicinal product.

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