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.  

Clinical trial feasibility assessment and start-up tool (CTFAST).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14089-e14089
Author(s):  
Amanda Tice ◽  
Richard Dima ◽  
Wasif M. Saif ◽  
Melissa Panzo ◽  
Sarah R. Vaiselbuh
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Feasibility Analysis ◽  
Pharmacokinetic Studies ◽  
Research Experience ◽  
Team Members ◽  
Feasibility Assessment ◽  
Start Up ◽  
The Right

e14089 Background: Selecting the right clinical trials for patients remains a challenging job. The better the match between a clinical trial and the target patient population before conducting a study, the more likely the study will successfully reach the target goal of recruitment. We developed a feasibility assessment scoring system based on our vast clinical research experience, managing multiple sites across a large health system, applicable to oncology as well. Methods: Our feasibility team (FT) is responsible for identifying clinical trials and determining if they are an appropriate match for our institution and unique patient population. Once a potential trial is identified, FT performs a feasibility assessment of the research protocol to determine the resources required to conduct the trial. We developed a Clinical Trial Feasibility Assessment & Start-up Tool (CTFAST) to help sites streamline their feasibility assessments and track their trial through the start-up phase. With CTFAST a feasibility score is generated based on the cumulative value assigned to several items such as: sponsor, study type, pharmacokinetic studies, trial phase, etc. A feasibility scale is assigned as follows: > 25 – Accepted; 15-25 – On Hold; < 15- Rejected. Accepted studies are assigned a color coded priority track (fast, intermediate, routine), that allows team members to prioritize their studies accordingly. Once a study is accepted, the study is processed for enrollment. Results: CTFAST has increased productivity and clinical trial revenues by 40%. CTFAST allows for early identification of bottlenecks in workflow, thereby improving outcomes. By appropriately matching of clinical trials to our site, enrollments increased by 50% with an expanded clinical trial portfolio across 9 different departments. Study start-up times have been reduced to a minimum of 21 days and the use of time & effort has been optimized. Conclusions: CTFAST is replicable across all clinical trial sites and provides an expansive and critical feasibility analysis that is not attainable by traditional querying of investigators and questionnaires. It is an excellent work flow improvement tool as it critically analyzes all aspects of a study, prior to enrollment. When conducting an effective feasibility analysis the clinical trial site can optimize clinical trial outcomes.

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.

Patients Driving the Clinical Trial Designs – Democracy in Clinical Research

2019 ◽  
Vol 14 (4) ◽  
pp. 237-246
Author(s):  
Payal Bhardwaj ◽  
Jeba Kumar ◽  
Raj Kumar Yadav
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Retention Rate ◽  
Patient Centered ◽  
Regulatory Review ◽  
Patient Organizations ◽  
Patient Reported ◽  
Clinical Trial Designs ◽  
The Right

Background: Many of the clinical trials remain inefficient owing to the low retention rate, and an impact on the power of the study. In addition, regulatory bodies recommend including the patients’ experience, especially, patient-reported outcomes, while making clinical decisions, and approvals. Introduction: Patient centricity has reached the stage where patients are both willing and required to participate in clinical trial designs, regulatory review and experts on other panels. Efforts are being made in the right direction and there are multiple aspects that have been or are being addressed. Objective: The current article focuses on how to include patients in clinical trial designs, the benefits, challenges, and solutions. This means patients who were merely the participants until now, they will be the drivers of trials now, and hence the clinical trials will be more efficient and productive. Key Findings: There is a drive to enhance patients’ participation in clinical trial designs, especially, visits, efficacy outcomes and their expectations with the treatment. Patients want to remain informed, right from before participation to the completion of the trial. Patients are now an important part of regulatory review, as apparent from recent initiatives by the FDA and EMA. This will enhance patients’ awareness, and bring ownership and transparency. Various patient organizations, advocacy groups have made some great suggestions and taken initiatives in this direction. Clinical Trials Transformation Initiative, European Patient’s Academy on Therapeutic Innovation, and Patient- Centered Outcomes Research Institute are a few key initiatives. However, there is a set of challenges emanating from the complexity of trials, associated with unique mechanism of action of drugs, their efficacy and safety profiles, which has to be dealt with properly. Conclusion: Overall, the pharma domain is at the verge of putting the patient in the spotlight, to achieve a near-real democracy, where the clinical research is the by the patient, for the patient, and, of the patient.

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

Development of the CCRU kit squad: Centralization of biospecimen “kit” management.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 295-295
Author(s):  
Vanessa Speers
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Personalized Medicine ◽  
Management Practices ◽  
Online Service ◽  
Nursing Time ◽  
Software Training ◽  
Disease Site ◽  
The Right ◽  
Selection Of

295 Background: Personalized medicine has resulted in a rapid increase in biospecimens collection. Each biospecimen collected requires supplies that are provided in the form of “kits”. The number of kit types per protocol ranges anywhere from 2-60, with an average of 30 different kit types per trial. Historically, each trials nurse has managed their own kits resulting in large amounts of nursing time being spent on kit management. Kits took up a large amount of space in clinical areas, including expired kits, and they were being managed in no standardized fashion. Due to rapidly increasing biospecimen volumes, existing methods of kit management were no longer feasible and the CCRU Kit Squad was developed. Methods: Over the course of 12-mos, an extensive assessment of current kit management practices were reviewed with all disease site groups, including workflows and quantities utilized. An e-commerce software platform was selected, and semi-customized to centralize online ordering and receiving of kits, and the creation of a central location was setup for kit storage and daily operations. On-boarding of each group included retrieving existing kits from each nurse, uploading kits to the software, training each nurse to use the software, setting up accounts with each respective vendor for deliveries and re-supply, and disposing of expired kits. Results: Disease site groups were transitioned to the CCRU Kit Squad stepwise from Oct 2016 to Dec 2017 (15-mos), which included 80 nurses, 16 disease site groups, and over 400 clinical trials. By the end of 2017, the average number of kits ordered per day, and per month were 33 and 1003, respectively. Conclusions: The CCRU Kit Squad developed a centralized online service for kit management, thereby reducing administrative burden on clinical trial nurses. It has streamlined the management of biospecimen kits, eliminated wasted space in clinical areas, and facilitated the selection of the right kit for the right test at the right time.

scholarly journals Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa

2020 ◽  
pp. 954-958
Author(s):  
Olusola Solarin ◽  
Sulma I. Mohammed ◽  
Ntokozo Ndlovu ◽  
Verna Vanderpuye ◽  
Victoria Olaiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Therapies ◽  
Racial Profile ◽  
Research Organizations ◽  
Heavy Burden ◽  
Empiric Data ◽  
The Right ◽  
Global Population

Africa attracts < 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced.

scholarly journals Clinical trial design for progressive MS trials

2017 ◽  
Vol 23 (12) ◽  
pp. 1642-1648 ◽  
Author(s):  
Matteo Pardini ◽  
Gary Cutter ◽  
Maria Pia Sormani
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Progressive Multiple Sclerosis ◽  
Phase 2 ◽  
The Right ◽  
Selection Of Patients ◽  
Selection Of

The design of clinical trials is a key aspect to maximizing the possibility to detect a treatment effect. This fact is particularly challenging in progressive multiple sclerosis (PMS) studies due to the uncertainty about the right target and/or outcome in phase-2 studies. The aim of this review is to evaluate the current challenges facing the design of clinical trials for PMS. The selection of patients, the instrumental and clinical outcomes that can be used in PMS trials, and issues in their design will be covered in this report.

scholarly journals Participatory Design of a Clinical Trial Eligibility Criteria Simplification Method

2021 ◽  
Author(s):  
Yilu Fang ◽  
Jae Hyun Kim ◽  
Betina Ross Idnay ◽  
Rebeca Aragon Garcia ◽  
Carmen E. Castillo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Participatory Design ◽  
Eligibility Criteria ◽  
Database Querying ◽  
The Right

Clinical trial eligibility criteria are important for selecting the right participants for clinical trials. However, they are often complex and not computable. This paper presents the participatory design of a human-computer collaboration method for criteria simplification that includes natural language processing followed by user-centered eligibility criteria simplification. A case study on the ARCADIA trial shows how criteria were simplified for structured database querying by clinical researchers and identifies rules for criteria simplification and concept normalization.

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>

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