27 Sept. 2017 - Informed participation and patient empowerment: a patient-centred approach to improve paediatric clinical research

Webinar Topic 

Informed participation and patient empowerment: a patient-centred approach to improve paediatric clinical research

 

Webinar Date & Time

27 September2017 from 10:00 to 11:30 (CET)

 

Webinar Overview

Over the last years, a Europe-wide trend towards a patient-focused approach is developing and is influencing the decision-making process related to the clinical research. This new vision aims to draw on patient knowledge and experience in order to deliver benefits for all stakeholders of the drug development process, by favouring the identification of unmet needs, research priorities or as well as the optimization of clinical study design. In this context, the “patient empowerment” concept has been developed as an approach encouraging the active participation and self-determination of the patients in the caring procedure. An empowered patient acquires all the critical tools to make decisions regarding his/her health and interact with healthcare professionals. For this reason, the exchange of information and the constructive dialogue with the patients have become key points in clinical research.

In 2016, in fact, EUPATI (European Patients’ Academy) launched a public consultation, ended in September 2016 with the release of the EUPATI Guidances for patient involvement in the medicine research and development process. Likewise, the Consultation Document on “Summary of Clinical Trial Results for Laypersons” for the Implementation of Regulation (EU) No 536/2014 recommended a clear and comprehensible communication of the clinical trial results to the patient.

However, rarely all these attempts for the patient involvement pay attention to the paediatric population needs. Available data and publications show that ad hoc strategies to inform minors to be enrolled in clinical trials are seldom produced. The need to actively involve children in the decision-making process related to a clinical trial is in fact part of the updating guideline ‘Ethical considerations for clinical trials on medicinal products conducted with minors’ prepared by the European Commission and the Paediatric Committee within the Regulation EU 536/2014. A child-friendly approach is necessary not only in the daily clinical practice, but especially in all the activities related to the development and use of drugs. In case of studies involving children, age-tailored information booklets, assent forms and summaries of the results should be written in age appropriate, simple and understandable language to ensure ease reading by parents and children. Moreover, the investigators should obtain agreement from the child in addition to informed consent of the parents, even when this agreement is not mandatory by law.

The involvement of paediatric population in the decision-making process is also the aim of the YPAGs - Young Persons Advisory Groups, which represent a new global movement, providing fresh perspectives on research studies.

Overall, this webinar is intended to describe in details the added value of a patient approach and the peculiarities and great value of this approach in the paediatric context.

 

Presenters

Mariangela Lupo

Master’s Degree in Political Science, International Relations. Bachelor’s Degree in Linguistic Mediation in the European Union. Responsible for Training and Communication and for the paediatric patients’ empowerment at Consorzio per Valutazioni Biologiche e Farmacologiche and the TEDDY Network (European Network of Excellence for Paediatric Clinical Research).

 

Attendance Fee

€ 90,- for EUCROF non-members

€ 60,- for EUCROF members only.

 

Deadline for registration

20 September 2017

 

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