Informed Participation and Patient Empowerment: A Patient- Centered Approach to Improve Pediatric Clinical Research

Mariangela Lupo, Angelica Intini and Doriana Filannino

A chapter in The Management of Clinical Trials from IntechOpen

Abstract: Over the last years, a Europe-wide trend toward 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, optimizing the 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. For this reason, in 2016, European Patients' Academy (EUPATI) launched a public consultation that ended in September 2016 with the release of the EUPATI guidance for patient involvement in the medicine research and development process. Likewise, the recommendations on the "Summaries 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 patients. However, rarely, all these attempts for the patient involvement pay attention to the pediatric population needs. An innovative approach for the patients' involvement in pediatric clinical research is represented by the Young Persons Advisory Groups, an organization composed of youths, patients, and carers, actively participating in clinical research and advising researchers and their teams.

Keywords: patient empowerment; patient involvement; patient-centered approach; child-friendly approach; age-tailored information; patient advocacy; YPAGs--Young Persons Advisory Groups (search for similar items in EconPapers)
JEL-codes: I18 (search for similar items in EconPapers)
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Persistent link: https://EconPapers.repec.org/RePEc:ito:pchaps:130271

DOI: 10.5772/intechopen.74528

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