scholarly journals Ethical issues related to clinical trials outside the International Conference on Harmonization regions

2011 ◽  
Vol 3 (12) ◽  
pp. 1457-1460 ◽  
Author(s):  
Juntra Karbwang ◽  
Cristina Torres
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
International Conference

scholarly journals A Healthy Sense of Trust

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10
Author(s):  
Denis Horgan
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Big Data ◽  
Data Protection ◽  
Fast Moving ◽  
Ethical Issues ◽  
Personalised Medicine ◽  
Drug Pricing ◽  
The Right ◽  
The Eu

In the fast-moving arena of modern healthcare with its cutting-edge science it is already, and will become more, vital that stakeholders collaborate openly and effectively. Transparency, especially on drug pricing, is of paramount importance. There is also a need to ensure that regulations and legislation covering, for example the new, smaller clinical trials required to make personalised medicine work effectively, and the huge practical and ethical issues surrounding Big Data and data protection, are common, understood and enforced across the EU. With more integration, collaboration, dialogue and increased trust among each and every one in the field, stakeholders can help mould the right frameworks, in the right place, at the right time. Once achieved, this will allow us all to work more quickly and more effectively towards creating a healthier - and thus wealthier - European Union.

scholarly journals Evaluation of Knowledge, Attitudes and Experience of off-label Drug Prescribing Practice among Physicians in Baghdad City Hospitals

2019 ◽  
Vol 28 (2) ◽  
pp. 115-123
Author(s):  
Aysha M. Shanshal ◽  
Ahmed H. Ataimish
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Pharmaceutical Companies ◽  
Cross Sectional ◽  
Off Label ◽  
Healthcare Settings ◽  
Prescribing Practice ◽  
Self Administered Questionnaire

Abstract The present study aims to assess the knowledge, attitude, and experience of off-label prescribing practice among physicians in Baghdad city hospitals. This cross-sectional study was performed through the period from November 1st 2018 to March 2019 at 17 hospitals, a self-administered questionnaire was utilized to collect data from the physicians, and the targeted hospitals were randomly selected at different regions in Baghdad City area. Out of the 400 distributed questionnaires to the physicians, 383 of them were returned completed, 57.2% indicated that they were reasonably familiar with the term “off label drug”, 57.7% mentioned that the most common medical reasons for the prescribing off-label drugs were unavailability of alternatives, 67.6%, 65.5% had concerns regarding its safety and efficacy respectively, 62.7% agreed that the (MOH) authority should provide an incentive to stimulate pharmaceutical companies to perform clinical trials in Iraqi patients, 49.1% believed that clinical trials that recruit volunteers involve ethical issues. Extensive efforts are required to implant programs, regulations and guidelines to control the off-label prescribing practice among the Iraqi healthcare providers who are authorized to prescribe medications at different healthcare settings.    

scholarly journals Il trapianto di utero. Aspetti medici, bioetici e giuridici

2015 ◽  
Vol 64 (1) ◽  
Author(s):  
Maurizio Faggioni
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Standard Practice ◽  
Alternative Option ◽  
Uterine Transplantation

Le donne con infertilità da fattore uterino (FUI) dovuto a motivi congeniti (es. sindrome di Rokitansky) o a isterectomia non hanno alcuna possibilità di realizzare il loro desiderio di maternità se non ricorrendo all’adozione o alla maternità surrogata che, però, è proibita in molti paesi. Il trapianto di utero, attualmente in studio, potrebbe rappresentare una alternativa per le donne che desiderano fare esperienza della gravidanza. Dopo decenni di ricerche animali, in Svezia si è avuto la prima nascita dopo trapianto di utero e fecondazione in vitro e questo prova che il trapianto di utero potrebbe essere un trattamento per la FUI. In linea di principio il trapianto è accettabile, ma ci sono molti problemi etici che devono essere considerati nel contesto della sperimentazione e di una eventuale introduzione nella pratica clinica. ---------- Women with uterine factor infertility (UFI) stemming from congenital causes (e.g. Rokitansky syndrome) or from hysterectomy are not able to fulfill their longing for motherhood except resorting to adoption or surrogacy, a practice that is forbidden in many countries. The uterine transplantation is currently under study as an alternative option for women who desire experience pregnancy. After decades of animal researches, in Sweden the first livebirth after uterine transplantation and IVF has been reported and this report is a proof for uterine transplantation as a treatment for UFI. Uterine transplantation is, as principle, morally acceptable, but many ethical issues must be considered in the context of clinical trials and eventually of standard practice.

scholarly journals Ethical Issues and Barriers for Multi-National Paediatric Clinical Trials: The Challenging Experience of the DEEP Project

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4820-4820
Author(s):  
Viviana Giannuzzi ◽  
Mariagrazia Felisi ◽  
Hugo Devlieger ◽  
Aurelio Maggio ◽  
George Papanikolaou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Descriptive Analysis ◽  
National Level ◽  
Comparative Trial ◽  
Phase Iii ◽  
Eu Countries ◽  
Paediatric Trial ◽  
Significant Difference ◽  
The Eu

Introduction: The procedures and requirements for the clinical trial application (CTA) to Ethics Committees (ECs) and/or Competent Authorities (CAs) are not fully harmonised, and this is even more evident when non-EU countries are involved. This lack of harmonisation makes more difficult the approach in the case of 'small populations', such as children and patients affected by rare diseases. A phase III efficacy-safety comparative trial (DEEP-2) involving paediatric patients affected by transfusion dependent haemoglobinopathies from seven European and non-European countries (Albania, Cyprus, Greece, Italy, United Kingdom, Egypt, Tunisia) was carried out in the context of a FP7 project (HEALTH-F4-2010-G.A. n. 261483) and included in an agreed Paediatric Investigation Plan. Aims: The aims of this paper are to describe in a complex multi-national/multi-ethnic framework the different provisions and procedures to authorise a paediatric trial in EU/non-EU countries and to evaluate the possible impact of the following key indicators on the timing of ECs approval and CAs authorisation: complexity of the national/local provisions and procedures to authorise a paediatric trial, including the number of ECs and CAs to be addressed; number and type of additional local/national documentation; number of queries from CAs and ECs; geographic setting (EU and non-EU). Methods: The following information was collected from official websites and through a survey addressed to Principal Investigators: The regulatory and legal frameworks in force at the time of the submission of DEEP-2 in each involved country;The procedures required at local/national level (i.e. number of ECs and CAs to be addressed, parallel or subsequent submission to the CA and the EC, preparation of the CTA form and documents required from CAs and ECs);The timing of ECs approval and CAs authorisation, including number and types of queries, were collected from DEEP-2 Trial Master File. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model (GLM) analysis were used to describe results and to analyse significance of the considered indicators. Results: In the EU countries, relevant legislative acts apply and include GCP and specific procedures for paediatric trials, in non-EU countries GCP guidelines apply but have not been implemented in the national laws regulating clinical trials. Moreover, within the 4 EU Member States a different approach was in place, even if under the same rules (i.e. Directive 2001/20/EC as implemented in the national law) with distinctive documents required for the CTA in almost all the EU countries compared with the EC provisions. The CTAs were performed in the period June 2012 - September 2015 in 23 trial sites. The EC approvals and CA authorisations were issued between January 2013 - September 2015. In the EU countries, the authorisation process was completed within 7,3 to 33,8 months (median = 15 months), while in non-EU countries, the authorisation process was completed by 7 months (median = 4 months) (figure 1). In particular, the comparison of the CA time authorisation shows a significant difference between EU and non-EU clusters (p = 0.001); however, if the statistical model is adjusted for the number of EC requests as covariate, the difference is not significant. Thus, it seems that the main factor influencing the time for EC approval is the number of requests for changes/clarifications (mainly on informed consent/assent, study protocol, insurance) (figure 2). Conclusion: Delays in completion of the authorisation phase in many countries seems to be a relevant issue and the timeframes for the authorisation in EU countries are not compliant with the European requirements (60 days for single opinion release and 30 days for its acceptance, as stated in Directive 2001/20/EC). The main reasons for delay is the complexity of the procedures and the requests from the ECs/CAs. In non-EU countries, procedures are different and faster with less requests from ECs and CAs. The upcoming application of a stronger set of rules, CT-Regulation (EU) 536/2014, is expected to harmonise practices in Europe and possibly outside Europe. The final aim of this change should be to assure a good balance between a timely approval and a high-level of children protection. Disclosures Reggiardo: CVBF: Consultancy. Tricta:ApoPharma: Employment.

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