The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

2008 ◽  
Vol 15 (2) ◽  
pp. 153-161 ◽  
Author(s):  
Herman Nys ◽  
Kris Dierickx ◽  
Wim Pinxten
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Legal System ◽  
Human Person ◽  
Ethics Committee ◽  
Pediatric Research ◽  
European Directive ◽  
Clinical Trial Directive ◽  
Medical Experiments ◽  
Protocol Review

AbstractThe European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

scholarly journals Authors’ Responsibilities and Ethical Publishing

2018 ◽  
Vol 13 ◽  
Author(s):  
Louise Gabrielle Shewan ◽  
Andrew J. Stewart Coats ◽  
Michael Henein
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ethics Committee ◽  
Copyright Clearance ◽  
Competing Interests ◽  
Full Responsibility ◽  
Exceptional Circumstance ◽  
Human Ethics ◽  
The Right

The International Cardiovascular Forum Journal requires authors to abide by the following guidelines:Manuscript: The corresponding author declares that the manuscript has not been published and is not under consideration elsewhere.Authorship: The corresponding author takes full responsibility for the list of authors.  Any modification to the author list including order and composition can only be approved by the Editor-in-Chief following signed agreement from all the authors listed on the original submission.Ethics: The corresponding author states that the material presented has been obtained with the approval of all appropriate animal and/or human ethics committee(s).Permissions: The corresponding author on behalf of all authors confirms whether explicit written consent to publish has been received from any people described, pictured, or recorded and that formal copyright clearance is obtained to publish any video or audio recordings.Registration of Clinical Trials: Prospective registration of any clinical trial in a publically accessible database is a requirement for later publication of such trials in ICFJ. In exceptional circumstance if the trial is not registered, or is registered retrospectively, the reasons for this must be given.Competing Interests: All authors must declare all relevant competing interests (financial, or non-financial, professional, or personal) and state all funding sources.Attribution: The corresponding author accepts full responsibility for the accurate citation and acknowledgement of any material reproduced from other publications including the author’s own prior work.It is incumbent upon the corresponding author to consult the Editor-in-Chief should there be any variance of the above. The Editor-in-Chief retains the right to retract any submission found to be in breach of the above guidelines.  

scholarly journals SITUATION OF HUMAN RESOURCES OF ORGANIZATIONS CONDUCTING CLINICAL TRIALS IN HANOI CITY, IN 2019

2021 ◽  
Vol 62 (4) ◽  
Author(s):  
Pham Phuong Lien
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knowledge Score ◽  
Good Clinical Practice ◽  
Ethics Committee ◽  
Cross Sectional ◽  
Policy Makers ◽  
Professional Qualification ◽  
Trial Staff ◽  
Clinical Drug

The study was carried out in order to provide useful information for policy-makers on enactingappropriate regulations to improve the effectiveness of clinical drug testing.The “cross-sectional descriptive design” was applied in the research; collecting secondary datato statistic the number and structure of staff at clinical trial organizations in Hanoi. Quantitativeinterviews with pre-designed questionnaires was implemented to describe the knowledge related to“good clinical practice” of the researchers belong to the above organizations.Main results: The number of staff working in clinical trials at Hanoi organizations is relativelyresponse to demand and has appropriate professional qualification. In which the highest percentageis doctors (accounting for 70.33%). Clinical trial staff have a relatively good knowledge about “goodclinical practice”. The average knowledge score of the interviewees is 44.8/50 points. However, thereare some content related to the “ethics committee in research” and “responsibility of researcher inthe clinical trial” have a relatively low percentage of staff correctly answering

scholarly journals Etyczne aspekty prowadzenia badań klinicznych na tle regulacji karnomaterialnych

2019 ◽  
Vol 27 ◽  
pp. 73-89
Author(s):  
Karolina Piech
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Criminal Law ◽  
Ethical Principles ◽  
Medicinal Products ◽  
Ethical Aspects ◽  
Medical Experiments ◽  
State Of Affairs

Ethical aspects of clinical trials in the context of criminal-law regulationsThe article discusses the issue of rules of conducting clinical trials, both in criminal and ethical terms. The author presents successively the principles of conducting medical experiments, including research on medicinal products with the participation of people, especially focusing on the issue of risk that threatens the patient. Next, the ethical principles of conducting clinical trials, classified by international rank acts, are described. The author compares the content of two groups of norms, striving to answer the question of whether it is possible that such a state of affairs exists, in which a clinical trial would be legally accepted, but would not be characterized by the attribute of ethics.

scholarly journals Archival and management of clinical trial documents

2021 ◽  
Vol 8 (1) ◽  
pp. 101
Author(s):  
Mehnaaz Alam ◽  
D. Yamini Sai Nikitha ◽  
Sai Sugun Jala ◽  
Gulam Khaleel Ahmed
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Specialty ◽  
Ethics Committee ◽  
X Rays ◽  
Clinical Knowledge ◽  
Secure Systems ◽  
Post Trial ◽  
Recovery Procedure

<p class="abstract">Clinical trial documents are all records, in any type which incorporates written, electronic, magnetic, optical records, scans, x-rays and electrocardiograms that describe or record the strategy, conduct and results of an effort, the factors poignant an effort and the actions taken. Such a record is thought as document and method is documentation. The documents collected before, throughout and once clinical trials give proof that the study was conducted, the information collected is correct and valid which the investigator and sponsor conducted the trial in line with ICH GCP tips is thought as Trial master file. because of exaggerated quality of studies, particularly medical specialty studies, and therefore the issue managing paper TMF’s for various departments, most organizations have moved to eTMF. Archiving may be a key demand to guage post trial observance and analysis and to facilitate any analysis before initiation of an effort and deposit strategy should be developed. It includes the subsequent parts documents to be archived, amount of archiving, location, retrieval or access of archived documents, disaster recovery, procedure of clinical knowledge archiving, archiving by an ethics committee, archiving by the investigator. Archiving of trial documents helps to store knowledge safely and firmly for future use with facilities like secure systems and e-back up.</p>

scholarly journals Controlled Clinical Trials with Doping Substances in Sports Law

2015 ◽  
Vol 46 (3) ◽  
pp. 827
Author(s):  
Erwin Deutsch
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sports Medicine ◽  
German Law ◽  
Ethics Committee ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Sports Law ◽  
Medical University

The research ethics committee of a German medical university recently faced a totally new problem. The department for sports medicine had asked the committee to approve a protocol for a controlled clinical trial about the efficacy and safety of doping substances in cycling. This article considers the difficulties of the German law on this matter.

Impact of Physician to Physician Interactions Utilizing Case Based Learning Workshops to Accelerate Accrual to Lymphoma Trials.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1418-1418
Author(s):  
John Eckardt ◽  
Nora Ku ◽  
Annemieke DeMaggio ◽  
Omair Peracha ◽  
Nick Levonyak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
The United States ◽  
Exclusion Criteria ◽  
Site Specific ◽  
Case Based Learning ◽  
Protocol Review ◽  
Case Based ◽  
Patient Accrual

Abstract Abstract 1418 Poster Board I-441 Introduction: Seventy percent of clinical trials in the United States are delayed by one to six months due to enrollment challenges. Barriers to accrual are site specific as well as protocol specific. Site specific challenges include perceptions of patient ineligibility and cumbersome screening processes. Protocol barriers include complexity of inclusion and exclusion criteria. Coomis et al (J Onc Prac 2009; 5:50) reported that 73% of overall clinical trial awareness was generated by physician interest. Therefore, the familiarity of investigators with each trial is crucial to optimizing patient accrual. The standard protocol initiation process relies on investigators and staff to attend an investigator's meeting. However, this approach does not focus on actual clinical patient presentations to determine trial eligibility or exclusion. As a result, many investigators may overlook key criteria for eligibility thus losing patients to enrollment. We have previously shown that interventions directly with PIs to increase PI awareness of inclusion/exclusion criteria of a clinical trial results in improved trial accrual (ASCO 2009, abs 6613). Methods: Investigator focused Accrual Workshops (AW) are used to increase patient enrollment to oncology clinical trials. While a standard investigator meeting includes protocol review, AW first create a compelling scientific story to re-engage the investigators in the trial. The key to these AW is the use of case-based learning to highlight the clinical and scientific rationale of the trial as opposed to general protocol review. Results: Between May 2008 and May 2009, 14 AW were conducted for 5 separate studies including 2 lymphoma trials. The AW with less than 120 days of follow up (n=5) show no significant impact although there was a trend toward increased accrual. In those with more than 120 days of follow up (n=9), the mean increase in accrual was 108% with increased accrual following every AW (Figure 1). After those 9 AW, patient accrual per month increased 1.65 fold on average. Analysis of the 2 lymphoma clinical trials demonstrates a significant increase in accrual following AW of 230% and 40%, respectively. Conclusion: AW using physician to physician clinical case-based learning provide an effective means of educating investigators and research staff in the identification of patients who meet the criteria for participation in clinical trials. The impact of AW on clinical trial accrual is best seen over time and they are effective in lymphoma clinical trials as well as others. After every AW with more than 120 day follow up, accrual was accelerated. Disclosures: No relevant conflicts of interest to declare.

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

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