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Sharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a
Annalisa Landi1, Federica D'Ambrosio2, Silvia Faggion2
1Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, 70124 Bari, Italy.
Insights
The EPIICAL consortium developed practical solutions for ethical and regulatory challenges in international pediatric HIV research. This involved creating standardized agreements for data and biological sample transfer, aiding multi-national studies.
Area of Science:
- Pediatric infectious diseases
- Clinical trial management
- Bioethics and regulatory science
Background:
- The EPIICAL consortium aimed to establish a platform for novel therapeutic strategies in pediatric Human Immunodeficiency Virus (HIV) infection.
- Pediatric clinical studies within EPIICAL required complex cross-border transfer of biological samples and data.
- Academic partners often lack resources for managing multinational studies' ethical and regulatory aspects.
Purpose of the Study:
- To guide the EPIICAL consortium through ethical and regulatory complexities of international pediatric clinical studies.
- To support the design and preparation of multi-center, multinational pediatric studies.
- To develop practical solutions for data and sample transfer hurdles in pediatric HIV research.
Main Methods:
- Established a dedicated expert Working Group focusing on ethical and regulatory compliance.
- Developed structured informed consent and assent templates for pediatric participants.
- Implemented data sharing and material transfer agreements to govern sample and data exchange.
Main Results:
- Provided guidance on ethical and regulatory aspects throughout the project lifecycle.
- Facilitated the design and preparation of prospective and retrospective multi-center studies.
- Established robust agreements for regulating the transfer of biological samples and associated data.
Conclusions:
- Dedicated expert support and ad hoc agreements are effective in overcoming ethical and regulatory hurdles in international pediatric clinical research.
- Standardized protocols and agreements streamline the transfer of data and samples, crucial for advancing pediatric HIV research.
- The EPIICAL model offers practical solutions for multinational collaborations involving vulnerable pediatric populations.
Abstract:
EPIICAL (Early treated Perinatally HIV-Infected individuals: Improving Children's Actual Life) is a consortium of European and non-European research-driven organizations inter-connected with the aim of establishing a clinical and experimental platform for the early identification of novel therapeutic strategies for the pediatric Human Immunodeficiency Virus (HIV). Within the EPIICAL project, several pediatric clinical studies were conducted, requiring the collection and transfer of biological samples and associated data across boundaries within and outside Europe. To ensure compliance with the applicable rules on pediatric data and sample transfer and to support the efforts of academic partners, which may not always have the necessary expertise and resources in place for designing, managing and conducting multi-national studies, the consortium established a dedicated expert Working Group. This group has guided the consortium since the start of the project through the complexities of the ethical and regulatory aspects of international clinical studies. The group provided support in the design and preparation of the prospective and retrospective multi-center and multi-national pediatric studies with a focus on the clinical study protocols, informed consent and assent forms. In particular, well-structured informed consent and assent templates were developed, and data sharing and material transfer agreements were set up to regulate the transfer of samples among partners and sites. We considered that such support and the implementation of ad hoc agreements could provide effective practical solutions for addressing ethical and regulatory hurdles related to sharing data and transferring samples in international pediatric clinical research.
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