Informed consent for paediatric clinical trials in Europe

Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; Wildt, Saskia N. de

doi:10.1136/archdischild-2015-310001

Cited by 50 publications

(45 citation statements)

References 12 publications

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“…A unique definition of legal age of consent is lacking, and the validity of assent and age-grouping is therefore not harmonized across Europe. As the EnprEMA marked in the paper 'Informed consent for paediatric clinical trials in Europe', usually the legal age for the informed consent is 18 years, but it differs in some countries: in Austria, it is 14; in Finland and Denmark, it is 15; and in the UK, it is 16 [27]. Specific characteristics in terms of informative material to be provided as well as requirements on the matter of rights of the patient to sign informed consent or assent, whether in addition or not to the parent's consent are detected [27,28].…”

Section: Informed Consent and Assent For Paediatric Groupsmentioning

confidence: 99%

“…As the EnprEMA marked in the paper 'Informed consent for paediatric clinical trials in Europe', usually the legal age for the informed consent is 18 years, but it differs in some countries: in Austria, it is 14; in Finland and Denmark, it is 15; and in the UK, it is 16 [27]. Specific characteristics in terms of informative material to be provided as well as requirements on the matter of rights of the patient to sign informed consent or assent, whether in addition or not to the parent's consent are detected [27,28]. Solving this issue is of primary importance in the perspective of implementing the new European Regulation, since the lack of EC practice harmonization will impede the achievement of a unified evaluation of PCT applications at central level.…”

Section: Informed Consent and Assent For Paediatric Groupsmentioning

confidence: 99%

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Challenges in Paediatric Clinical Trials: How to Make It Feasible

Chiaruttini¹,

Felisi²,

Bonifazi³

2018

The Management of Clinical Trials

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The number of paediatric clinical trials in EU has remarkably increased in the last decade in response to the implementation of the new Paediatric Regulation and incentives aiming to define the need of child-specific drug development. Nevertheless, the gap between the number of paediatric and adult-randomised controlled trials is still substantial in almost every major clinical specialty. Economic, ethical, technological, geographical and cultural factors can influence the paediatric drug development and can represent the challenges to be faced for a smooth conduction of a paediatric clinical trial. The need for trials and paediatric patient's engagement to commensurate with the approved paediatric investigation plans is so high that it is crucial to correctly address key factors. Particular care should be taken to develop well-designed studies, with efficient management plans, experienced administrative and healthcare personnel, awareness of socio-cultural features of the geographic areas involved and good communication with patients and their families in order to ensure 'trial preparedness'. A case study on a multinational paediatric clinical trial, presented within the recently ended research project 'DEferiprone Evaluation in Paediatrics (DEEP)', was reported to exemplify some of the challenges encountered by the authors and the actions taken to overcome them.

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Section: Informed Consent and Assent For Paediatric Groupsmentioning

confidence: 99%

Section: Informed Consent and Assent For Paediatric Groupsmentioning

confidence: 99%

Challenges in Paediatric Clinical Trials: How to Make It Feasible

Chiaruttini¹,

Felisi²,

Bonifazi³

2018

The Management of Clinical Trials

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“…Obtaining informed consent is also an issue because in the Netherlands both parents need to give permission, and from 12 years of age the child must sign as well . As shown in the Informed Consent and Assent Tool kit, differences between national consent procedures exist in Europe . Especially for international studies, a uniform guideline is desirable.…”

Section: Rcts In Children With Epilepsymentioning

confidence: 99%

“…33 As shown in the Informed Consent and Assent Tool kit, differences between national consent procedures exist in Europe. 34 Especially for international studies, a uniform guideline is desirable.…”

Section: Legal and Ethical Considerationsmentioning

confidence: 99%

Investigator‐initiated randomized controlled trials in children with epilepsy: Mission impossible?

2016

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SummaryObjectiveIn children many antiepileptic drugs (AEDs) are prescribed off‐label due to a lack of well‐designed randomized controlled trials (RCTs). We conducted a multicenter RCT in the Netherlands to compare levetiracetam and valproic acid as monotherapy in children with newly diagnosed epilepsy. After 2 years, we had to stop this investigator‐initiated trial prematurely because the inclusion rate was too low. We analyzed the reasons for this failure, assessed the various issues involved in performing RCTs in children, and now give recommendations for future studies.MethodsA questionnaire was completed by all investigators involved in the study. It included questions about the motivation to participate and the perceived reasons for recruitment failure. We also studied literature about financial, logistic, legal, and ethical aspects of RCTs in children.ResultsMain reasons for recruitment failure were overestimation of the number of eligible AED‐naive children referred by general pediatricians; personal preferences of investigators for specific antiepileptic drugs; and the extensive administrative load due to extra regulations and guidelines for children. Fundraising for investigator‐initiated trials is difficult and the majority of RCTs concerning AEDs are sponsored by pharmaceutical companies. Involving children requires balancing between protection and participation; the randomization procedure and obtaining informed consent are complex for both children and parents.SignificancePerforming RCTs with AEDs in children is important but complicated by logistic, regulatory, legal, and ethical restrictions. Based on our recent experience, our advice to colleagues who are planning a similar trial would be to perform a feasibility pilot study; to set up intensive collaboration with referring pediatricians; to arrange support of a clinical trials unit and a local research nurse during the complete trial period; and to incorporate the possibility of extending the recruitment period. Major investments, both financially from governmental organizations and in time, are imperative for independent RCTs in children.

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“…(21) Optout consent where study information is publicised at waiting room, hospital and ward level, is implemented in some countries for observational studies, but in others regulatory and data protection agencies do not permit this. Differences in parental consent requirements for IDP research may also complicate IDP research; currently in some countries only one parent must sign, whereas in others both parents must give written consent (26). This may be difficult if a parent is also incapacitated or unavailable in the case of a pandemic.…”

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confidence: 99%

Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe

Gal¹,

Gobat²,

Francis³

et al. 2019

Pediatric Infectious Disease Journal

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Background: Infectious disease pandemics (IDP) pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of IDPs require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician-researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe. Methods: Mixed method study in 2 stages, recruiting pediatric clinician-researchers with experience of conducting pediatric infectious disease (ID) research in clinical settings in Europe. Stage one was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage two; an on-line consensus survey to identify pediatric clinician-researchers priorities to enable IDP research. Results: Twenty-three pediatric clinician-researchers attended the workshop and thirty-nine completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: 1) Clarity within the European Clinical Trials Directive for pediatric pandemic research; 2) Simplified regulatory processes for research involving clinical samples and data; and 3) Improved relationships between regulatory bodies and researchers. Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision makers and regulators and to develop a strategy to lobby for change.

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Informed consent for paediatric clinical trials in Europe

Cited by 50 publications

References 12 publications

Challenges in Paediatric Clinical Trials: How to Make It Feasible

Challenges in Paediatric Clinical Trials: How to Make It Feasible

Investigator‐initiated randomized controlled trials in children with epilepsy: Mission impossible?

Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe

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