National Academies Press: OpenBook
« Previous: 7 Critical Considerations for Facilitating Medical Product Research and Development
Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

8

Crosscutting Themes and Closing Remarks

Yamada highlighted six main themes1 that emerged across the workshop discussions of the platform areas described in Chapter 7 (summarized in Table 7-1).

  • 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.

Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
  • 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.

CLOSING REMARKS

Ceci Mundaca-Shah of the National Academies of Sciences, Engineering, and Medicine and Senior Program Officer for the Global Health Risk

Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

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.

Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

This page intentionally left blank.

Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 83
Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 84
Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 85
Suggested Citation:"8 Crosscutting Themes and Closing Remarks." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 86
Next: Appendix A: References »
Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary Get This Book
×
Buy Paperback | $45.00 Buy Ebook | $35.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak.

In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!