Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

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LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

Review of European and Comparative Law ◽

10.31743/recl.4312 ◽

2017 ◽

Vol 28 (1) ◽

pp. 67-84

Author(s):

Katarzyna Syroka-Marczewska

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Adverse Reactions ◽

Legal Aspects ◽

Science And Society ◽

Medicinal Products ◽

Safety And Efficacy ◽

Pharmacodynamic Effects ◽

Trial Participants

A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.

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Key components and IT assistance of participant management in clinical research: a scoping review

JAMIA Open ◽

10.1093/jamiaopen/ooaa041 ◽

2020 ◽

Vol 3 (3) ◽

pp. 449-458

Author(s):

Johannes Pung ◽

Otto Rienhoff

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Computer Assisted ◽

Trial Participant ◽

Comprehensive Overview ◽

Definition Of ◽

Meta Analyses ◽

Assisted Management ◽

Trial Participants

Abstract Objectives Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management. Methods A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on trial participant-related proceedings, work procedures, or workflows, and assisting electronic systems. Results The literature search identified 1329 articles of which 111 were included for analysis. Participant-related procedures were categorized into 4 major trial processes: recruitment, obtaining informed consent, managing identities, and managing administrative data. Our results demonstrated that management of trial participants is considered in nearly every step of clinical trials, and that IT was successfully introduced to all participant-related areas of a clinical trial to facilitate processes. Discussion There is no precise definition of participant management, so a broad search strategy was necessary, resulting in a high number of articles that had to be excluded. Nevertheless, this review provides a comprehensive overview of participant management-related components, which was lacking so far. The review contributes to a better understanding of how computer-assisted management of participants in clinical trials is possible.

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How health literacy can enhance the design and conduct of clinical trials from consent to conclusion

Information Services & Use ◽

10.3233/isu-200082 ◽

2020 ◽

Vol 40 (1-2) ◽

pp. 41-49

Author(s):

Catina O’Leary ◽

Chris Casey ◽

Diane Webb ◽

Deborah Collyar ◽

Andrew Pleasant

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Health Literacy ◽

Medical Care ◽

Standard Medical Care ◽

Literacy Activities ◽

Trial Process ◽

Primary Focus ◽

Trial Participants ◽

Literacy Research

Health literacy research and interventions have provided multiple tools to improve communication between professionals and patients in clinical contexts for many years. Despite the reality that many patients participate in clinical trials in conjunction with standard medical care, only recently have efforts extended to address and improve the health literacy of both clinical trial researchers and participants. To date, the primary focus of health literacy activities in clinical trials has centered on communicating trial results to trial participants. This report describes the opportunities and strategies necessary to layer health literacy activities across the clinical trial process from consent to conclusion.

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Clinical trials screening: An opportunity to increase medical care access

Gastroenterology ◽

10.1016/s0016-5085(01)82035-7 ◽

2001 ◽

Vol 120 (5) ◽

pp. A410-A410

Author(s):

T KOVASC ◽

R ALTMAN ◽

R JUTABHA ◽

G OHNING

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Care Access

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Understanding functional illiteracy from a policy, adult education, and cognition point of view: Towards a joint referent framework

Zeitschrift für Neuropsychologie ◽

10.1024/1016-264x/a000255 ◽

2019 ◽

Vol 30 (2) ◽

pp. 109-122

Author(s):

Aleksandar Bulajić ◽

Miomir Despotović ◽

Thomas Lachmann

Keyword(s):

Adult Education ◽

Operational Definition ◽

Literacy Skills ◽

Point Of View ◽

Industrialized Countries ◽

Functional Illiteracy ◽

Scale Levels ◽

Components Of Reading ◽

The One ◽

Definition Of

Abstract. The article discusses the emergence of a functional literacy construct and the rediscovery of illiteracy in industrialized countries during the second half of the 20th century. It offers a short explanation of how the construct evolved over time. In addition, it explores how functional (il)literacy is conceived differently by research discourses of cognitive and neural studies, on the one hand, and by prescriptive and normative international policy documents and adult education, on the other hand. Furthermore, it analyses how literacy skills surveys such as the Level One Study (leo.) or the PIAAC may help to bridge the gap between cognitive and more practical and educational approaches to literacy, the goal being to place the functional illiteracy (FI) construct within its existing scale levels. It also sheds more light on the way in which FI can be perceived in terms of different cognitive processes and underlying components of reading. By building on the previous work of other authors and previous definitions, the article brings together different views of FI and offers a perspective for a needed operational definition of the concept, which would be an appropriate reference point for future educational, political, and scientific utilization.

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Clinical trials — the personal perspective of the research physician?

Annals of the Russian academy of medical sciences ◽

10.15690/vramn1356 ◽

2020 ◽

Vol 75 (3) ◽

pp. 256-263

Author(s):

Maria Y. Egorova ◽

Irina A. Shuvalova ◽

Olga I. Zvonareva ◽

Igor D. Pimenov ◽

Olga S. Kobyakova ◽

...

Keyword(s):

Clinical Trials ◽

Medical Care ◽

New Technologies ◽

Healthcare Providers ◽

Study Drug ◽

Well Being ◽

Personal Perspective ◽

Public And Private ◽

Factors Affecting ◽

To Receive

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).

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ANALYSIS OF THE MAIN INDICATORS CHARACTERIZING MEDICAL CARE FOR CHILDREN WITH CANCER IN SAINT-PETERSBURG AND IN THE LENINGRAD REGION IN 2013-2017

Problems in oncology ◽

10.37469/0507-3758-2019-65-1-77-82 ◽

2019 ◽

Vol 65 (1) ◽

pp. 77-82

Author(s):

Maksim Rykov ◽

Ivan Turabov ◽

Yuriy Punanov ◽

Svetlana Safonova

Keyword(s):

Mortality Rate ◽

Medical Care ◽

Statistical Data ◽

Leningrad Region ◽

Children With Cancer ◽

Health Committee ◽

The Government ◽

Delivery Of Medical Care ◽

One Year ◽

The One

Background: St. Petersburg is a city of federal importance with a large number of primary patients, identified annually. Objective: analysis of the main indicators characterizing medical care for children with cancer in St. Petersburg and the Leningrad region. Methods: The operative reports for 2013-2017 of the Health Committee of the Government of St. Petersburg and the Health Committee of the Leningrad Region were analyzed. Results. In 2013-2017 in the Russian Federation, 18 090 primary patients were identified, 927 (5.1%) of them in the analyzed subjects: in St. Petersburg - 697 (75,2%), in the Leningrad Region - 230 (24,8%). For 5 years, the number of primary patients increased in St. Petersburg - by 36%, in the Leningrad Region - by 2,5%. The incidence increased in St. Petersburg by 18,1% (from 14,9 in 2013 to 17,6 in 2017 per 100 000 of children aged 0-17). The incidence in the Leningrad Region fell by 4.9% (from 14.4 in 2013 to 13.7 in 2017). Mortality in 2016-2017 in St. Petersburg increased by 50% (from 2 to 3), in the Leningrad Region - by 12,5% (from 2,4 to 2,7). The one-year mortality rate in St. Petersburg increased by 3,9% (from 2,5 to 6,4%). In the Leningrad Region, the one-year mortality rate decreased from 6,5% in 2016 to 0 in 2017. The number of pediatric oncological beds did not change in St. Petersburg (0,9 per 10,000 children aged 0-17 years) and the Leningrad Region (0). In St. Petersburg patients were not identified actively in 2016-2017; in the Leningrad Region their percentage decreased from 8,7 to 0. The number of oncologists increased in St. Petersburg from 0,09 to 0.12 (+33,3%), in the Leningrad Region - from 0 to 0,03. Conclusion: Morbidity in St. Petersburg and the Leningrad region is significantly different, which indicates obvious defects in statistical data. Patients were not identified during routine preventive examinations which indicate a low oncologic alertness of district pediatric physicians. Delivery of medical care for children with cancer and the statistical data accumulation procedures should be improved.

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Democracy and Political Culture

10.1093/oso/9780198834205.001.0001 ◽

2019 ◽

Author(s):

Ross McKibbin

Keyword(s):

Political Culture ◽

Case Studies ◽

Social System ◽

Political System ◽

Democratic Politics ◽

Social Structures ◽

The Political ◽

The Subject ◽

The One ◽

Definition Of

This book is an examination of Britain as a democratic society; what it means to describe it as such; and how we can attempt such an examination. The book does this via a number of ‘case-studies’ which approach the subject in different ways: J.M. Keynes and his analysis of British social structures; the political career of Harold Nicolson and his understanding of democratic politics; the novels of A.J. Cronin, especially The Citadel, and what they tell us about the definition of democracy in the interwar years. The book also investigates the evolution of the British party political system until the present day and attempts to suggest why it has become so apparently unstable. There are also two chapters on sport as representative of the British social system as a whole as well as the ways in which the British influenced the sporting systems of other countries. The book has a marked comparative theme, including one chapter which compares British and Australian political cultures and which shows British democracy in a somewhat different light from the one usually shone on it. The concluding chapter brings together the overall argument.

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Intelligent Drug Development

10.1093/oso/9780199974580.001.0001 ◽

2014 ◽

Author(s):

Michael Tansey

Keyword(s):

Clinical Trials ◽

Cost Effectiveness ◽

Drug Development ◽

Clinical Research ◽

Development Process ◽

Drug Development Process ◽

Individual Trial ◽

Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

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An LQ Approach to Active Control of Vibrations in Helicopters

Journal of Dynamic Systems Measurement and Control ◽

10.1115/1.2801171 ◽

1996 ◽

Vol 118 (3) ◽

pp. 482-488 ◽

Cited By ~ 24

Author(s):

Sergio Bittanti ◽

Fabrizio Lorito ◽

Silvia Strada

Keyword(s):

Optimal Control ◽

Active Control ◽

Linear Quadratic ◽

Control Effort ◽

Vibration Effect ◽

Suitable Definition ◽

Lq Optimal Control ◽

The One ◽

Definition Of ◽

And Control

In this paper, Linear Quadratic (LQ) optimal control concepts are applied for the active control of vibrations in helicopters. The study is based on an identified dynamic model of the rotor. The vibration effect is captured by suitably augmenting the state vector of the rotor model. Then, Kalman filtering concepts can be used to obtain a real-time estimate of the vibration, which is then fed back to form a suitable compensation signal. This design rationale is derived here starting from a rigorous problem position in an optimal control context. Among other things, this calls for a suitable definition of the performance index, of nonstandard type. The application of these ideas to a test helicopter, by means of computer simulations, shows good performances both in terms of disturbance rejection effectiveness and control effort limitation. The performance of the obtained controller is compared with the one achievable by the so called Higher Harmonic Control (HHC) approach, well known within the helicopter community.

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