THE ROME MANIFESTO FOR AN ECOSYSTEM FOSTERING INNOVATION IN PEDIATRICS

Quality of care increases with investments in innovation, and innovation has the potential of revolutionizing healthcare, for the benefit of patients and of the whole healthcare system. This is particularly true in the field of pediatrics, as children are the citizens of the future. Though it may overlap with research, innovation has its own methodology, which is under-recognized in healthcare. Patients’ needs, as well as clinical and organizational needs may be addressed with powerful ideas that often remain unexplored.

Innovation thrives in interdisciplinary environments where competencies intersect with synergy for creating new values. Especially when innovation focuses on technological solutions, it requires the collaboration of different stakeholders for the processes of prototyping, evaluating business models, programming the way to the market and adoption in the healthcare setting.

New professional skills are required to manage the intersection of different professional profiles in the process of innovation. Healthcare workers and the general public should be able to access new educational paths for assimilating, speeding-up and fertilizing innovation processes in healthcare.

Moreover, the adoption of innovative, digital solutions in healthcare requires the development of ethical and regulatory frameworks, which should have the aim of protecting patients’ safety, patients’ privacy and of guaranteeing fair and impartial availability of innovative solutions to every citizen, in every area of the world, including low-income countries. Currently, the ethical and regulatory frameworks are still lacking or incomplete and not updated at national and international levels.

At present, innovation in pediatrics is left to the initiative of single individuals or organizations. This Manifesto intends to favor the establishment of an ecosystem for innovation in pediatrics. This ecosystem focuses on the fields of Digital Medicine and Digital

Health, encompassing electronic devices and apps in the field of Digital Therapeutics, Artificial Intelligence applications and innovative approaches for the study of -omics (genomics, transcriptomics, proteomics and metagenomics). In this ecosystem, needs can be addressed in a single pipeline, from idea generation to market, based on common methodology and ethical values and principles.

Principles

1. Pursue Ethics in the interest of patients and the community at large

Innovation should respect the dignity and autonomy of patients and innovators in the framework of the principles of autonomy, beneficence, non-maleficence and justice. Empathy and human relationship should guide priorities and best solutions. Public-private partnership (P3) in innovation should pursue synergy and should maintain transparency and accountability.

2. Always apply Interdisciplinarity

Collaboration across different disciplines, with no preclusion or prejudice should be pursued. Designing an innovative solution for an existing need always benefits from fresh ideas from experts coming from non-medical areas, such as design, architecture, engineering, communication, data science, experts in ethics and others.

3. Support Education for a change towards innovation

Novel educational programs represent a crucial objective of innovation. Interdisciplinarity is a key value of a dynamic educational path for present and future generations engaged in innovation in pediatric healthcare. A methodological foundation should be set for the evaluation of educational programs for health professionals and for patients in the long term, based on outcomes.

4. Empower and acknowledge patients (parents) as core team members

Identification of challenges from the patient/parent perspective should be considered in the innovation process, idea generation and in the co-creation and design of studies and experiments for the evaluation of new solutions. Patients/parents should participate in ethical committee meetings discussing innovation projects. Patients/parents should be actively involved in educational programs as students and teachers, in a spirit of continuous exchange.

5. Foster Data Sharing in innovation initiatives

Data sharing and data donation should be pursued since it improves and accelerates the development of data applications, including those using Artificial Intelligence. While respecting rights of data ownership, privacy and intellectual property, adequate infrastructures for data integration, open API for data linkage and transfer, blockchain, and Internet of Things across different institutions should be developed.

6. Apply privacy by design

Privacy is an essential part of any process, innovation included. For this reason, innovation should apply the principles of privacy protection and of patient values by design. Additionally, respecting the rights of data ownership and intellectual property is of primary importance.

7. Harness Real World Evidence for evaluating digital diagnostics and therapeutics

Discuss, develop and refine the most suitable methodologies useful for the evaluation of digital therapeutics and other digital applications, offer infrastructure and competence as a service for the evaluation of digital therapeutics and negotiate with regulatory agencies the most suitable and agile pathways to approve and monitor the use of digital applications in the community at large.

8. Leverage Communication and Openness for improving awareness

Circulation of data and ideas speed up innovation and empower network and single organizations. The design of communication processes should take into account empathy and take advantage of digital tools. Efficacy and impact of communication solutions should be evaluated and reviewed based on evidence and ethical principles to avoid false interpretations and fighting the diffusion of fake news.

9. Think Global

The involvement of low-income and underserved countries should be always explored at all stages of the innovation process. When possible, assessment and evaluation of innovations should be carried out in different cultural and geographic settings to explore the broadest implementation possible, respecting their values and traditions and promoting integration.

10. Make innovation Sustainable

Innovations should be evaluated for their sustainability over time by design. New values generated by innovation should be always analyzed, even when they are not monetary. Affordability of the development of innovation should be assessed.