- Trust among stakeholders was discussed as an essential element of success in responding to a crisis. Building trusted relationships across sectors (public, private, and philanthropic), among organizations within sectors, and with governments and institutions in the developing world needs to start before a crisis strikes. In working to foster trust among stakeholders, it is important to remember that trust takes time to build and effort to maintain, and stakeholders can have diverse interests and goals when coming to the table.
- Community engagement is a key element of preparedness. The product, the remediation, and the patient all come together in the communities, Yamada said. Engaging a community requires an understanding of the sociology, politics, standard practices, and history of that community. Clinical trials for the development of vaccines and therapeutics need the support of all local community leaders (traditional, religious, administrative, political, and sociocultural leaders) to foster participation and enhance compliance. Once products are approved and available, they are only of use if they can reach the local community and are accepted by the
1 These themes were presented at the workshop by Yamada and should not be construed as reflecting any group consensus.
patients, community leaders, and the larger community. The local community is also a partner in the deployment of interventions and the delivery of care.
- Ethical and legal considerations include issues such as patents, intellectual property, and data sharing; liability; and the general or blanket agreements and ethics assurances needed to conduct clinical trials. So that these issues do not act as barriers to a rapid collaborative response, Yamada said that the international community needs to come together around a legal framework and ethical principles that can be agreed upon (perhaps through treaties) during interepidemic periods and quickly implemented during emergencies.
- Leadership is essential in all areas of research and development. Leadership strategies will differ in routine versus emergency operations. It was discussed that in a public health emergency there is a need for a strong organizational system and a designated person or entity that will determine the priority of products to be tested in the face of limited clinical trial resources. This leadership structure should be established before the next crisis. Successful product development partnerships rely on leadership and accountability. It is also important to empower local leadership with the tools and support they need to deliver care to their people.
- Communication needs to take place at every step of the process. Local leadership and the public need to receive accurate information about the emerging disease threat, diagnosis, prevention and control, and available treatments including ongoing clinical trials and how they work (e.g., purpose, risks, benefits, and comparison groups), Kilmarx said. Awunyo-Akaba stressed the importance of also getting feedback from the community.
- Barriers to effective and efficient research and development of medical products for emerging infectious diseases were discussed across all steps in the process. The ability to continually learn and overcome barriers as they present will be critical for any plan to succeed. Rex highlighted the issue of sustainability as concern across the research and development spectrum. There is a common misconception, he said, that research and development is a tap that can be turned on and off: when something is needed, the tap is turned on and the results/products come out.
Ceci Mundaca-Shah of the National Academies of Sciences, Engineering, and Medicine and Senior Program Officer for the Global Health Risk
Framework Commission, thanked participants on behalf of the Commission. She reiterated the dual purpose of the workshop, both as a product of the Institute of Medicine and as one of the pillars of evidence for the Commission in preparing its independent report and recommendations that will be presented at the World Health Assembly Executive Board Meeting in January 2016. Yamada thanked the participants and noted that the work of the Commission would also be informed by several consultation meetings with other government, academic, nongovernmental organization, and private-sector stakeholders.
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