Wim Pinxten

Erasmus MC, Rotterdam, South Holland, Netherlands

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Publications (10)16.66 Total impact

  • [show abstract] [hide abstract]
    ABSTRACT: Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.
    European Journal of Pediatrics 10/2012; · 1.91 Impact Factor
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    ABSTRACT: For a significant number of patients, there exists no, or only little, interest in developing a treatment for their disease or condition. Especially with regard to rare diseases, the lack of commercial interest in drug development is a burning issue. Several interventions have been made in the regulatory field in order to address the commercial disinterest in these conditions. However, existing regulations mainly focus on the provision of incentives to the sponsors of clinical trials of orphan drugs, and leave unanswered the overarching question about the rightful place of orphan drugs in resource allocation systems. In this article, we analyse the ethical aspects of funding research and development in the field of rare diseases. We then propose an ethical framework that can help health policy makers move forward in the difficult matter of fairly allocating resources for the prevention, diagnosis and treatment of rare diseases.
    Journal of medical ethics 09/2011; 38(3):148-53. · 1.42 Impact Factor
  • Source
    Wim Pinxten, Kris Dierickx, Herman Nys
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    ABSTRACT: Over the past decades, considerable legislative effort has been made to facilitate and encourage clinical research in the European Union (EU). Hereby, specific attention has been paid to the urgent need to conduct research in minors. In this article, we will analyze the regulation that currently governs pediatric clinical research conduct at the supranational level of the EU and at the level of individual EU member states. Our analysis will focus on the way in which the national and supranational legal frameworks address five ethical issues that are specific to pediatric clinical research: (a) informed consent, (b) the necessity to conduct research in minor subjects, (c) the interests of the subject concerned, (d) the risks and burdens involved, and (e) the pediatric expertise of protocol review committees. We conclude by discussing the harmonization and diversification of the legal requirements that govern pediatric clinical research in the EU.
    Journal of cystic fibrosis: official journal of the European Cystic Fibrosis Society 06/2011; 10 Suppl 2:S183-98. · 3.19 Impact Factor
  • Wim Pinxten, Herman Nys, Kris Dierickx
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    ABSTRACT: In the course of the past decades, considerable effort has been expended on the ethical guidance and legal regulation of pediatric clinical trials in Europe. Nonetheless, the conduct of clinical research in the population of minors continues to generate myriad ethical and regulatory issues. This paper explores seven bottlenecks in the ethical guidance and legal regulation that currently govern pediatric clinical research: (1) the integration of research in therapy, (2) the education of clinicians, (3) the empowerment of families, (4) the harmonization of protocol review, (5) the assessment non-clinical research objectives, (6) the control of placebo use, and (7) the provision of fair incentives for pediatric research conduct. For all of these issues, a clear view on the way forward is largely lacking, either because these issues have not been discussed in depth to date or because the existing debates have failed to generate a generally supported consensus.
    European Journal of Pediatrics 12/2010; 169(12):1541-8. · 1.91 Impact Factor
  • Wim Pinxten, Herman Nys, Kris Dierickx
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    ABSTRACT: Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining access to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population.
    Journal of medical ethics 12/2010; 36(12):791-4. · 1.42 Impact Factor
  • Wim Pinxten, Kris Dierickx, Herman Nys
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    ABSTRACT: The involvement of minors in clinical research is inevitable to catch up with the lack of drugs labeled for pediatric use. To encourage the responsible conduct of pediatric clinical trials in the EU, an extensive legal framework has been developed over the past decade in which the practical, ethical, legal, social, and commercial issues in pediatric research are addressed. In this article, the European legal framework surrounding pediatric clinical trials is analyzed from the perspective of the major ethical concerns in pediatric research. The four principles of biomedical ethics will be used as a conceptual framework (1) to map the ethical issues addressed in the European legal framework, (2) to study how these issues are commonly handled in competent adults, (3) to detect workability problems of these paradigmatic approaches in the specific setting of pediatric research, and (4) to illustrate the strong urge to differentiate, specify, or adjust these paradigmatic approaches to guarantee their successful operation in pediatric research. In addition, a concise comparative analysis of the European regulation will be made. To conclude our analysis, we integrate our findings in the existing ethical discussions on issues specific to pediatric clinical research.
    European Journal of Pediatrics 02/2009; 168(10):1225-34. · 1.91 Impact Factor
  • Wim Pinxten, Herman Nys, Kris Dierickx
    The American Journal of Bioethics 02/2009; 9(1):21-3. · 4.00 Impact Factor
  • Wim Pinxten, Herman Nys, Kris Dierickx
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    ABSTRACT: The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in clinical research, we consider how existing "relationships of trust" can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research.
    Medicine Health Care and Philosophy 12/2008; 11(4):439-44. · 0.91 Impact Factor
  • Wim Pinxten, Kris Dierickx, Herman Nys
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    ABSTRACT: The 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.
    European Journal of Health Law 08/2008; 15(2):153-61.
  • W. Pinxten, H. Nys, K. Dierickx
    Journal of Cystic Fibrosis - J CYST FIBROS. 01/2008; 7.

Publication Stats

31 Citations
524 Views
16.66 Total Impact Points

Institutions

  • 2012
    • Erasmus MC
      Rotterdam, South Holland, Netherlands
  • 2008–2011
    • KU Leuven
      Louvain, Flanders, Belgium
  • 2009–2010
    • Leuven University College
      Louvain, Flanders, Belgium