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Suggested Citation:"Action Collaboratives." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 14
Suggested Citation:"Action Collaboratives." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 15
Suggested Citation:"Action Collaboratives." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 16
Suggested Citation:"Action Collaboratives." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 17

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Action Collaboratives Action collaboratives are ad hoc, participant-driven activities associated with the Forum that foster collaboration and information sharing among Forum members and external thought leaders and stakeholders. Action collaboratives engage experts with similar interests and responsibilities to analyze in-depth, high-priority issues and Action collaboratives are ad hoc, to advance the identified goals of the Forum and recommendations highlighted in participant-driven activities National Academies’ Consensus Study Reports. associated with the Forum that Advancing the Science of Patient Input in Medical Product foster collaboration and Research and Development information sharing among Forum There is growing momentum to incorporate patient input into medical product R&D members and external thought and regulatory decision-making processes. Converting traditionally anecdotal patient leaders and stakeholders. input to rigorous, credible evidence for use by a broad range of stakeholders— including academic and clinical researchers, medical product developers, patient/ disease advocacy groups, and regulatory decision makers—could better align medical product development and regulation with patient perspectives on disease experience, burden, management, and treatment. Many efforts have been launched to advance a science of patient input. However, there is a need to identify key gaps in the knowledge base and other barriers that impede progress and to develop an approach for addressing them. 14

Action Collaboratives This action collaborative was launched in 2017 to lay the groundwork for a research agenda to advance the science of patient input. Collaborative participants catalogued current efforts and progress in the science of patient input and identified gaps in the knowledge base and other barriers that impede progress. This work helped inform discussions at a public workshop hosted by the Forum on May 9, 2018, on Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda. Following the workshop, collaborative participants assembled a list of gaps and barriers organized by topic based on points raised by workshop participants. The list was circulated among a variety of stakeholders to solicit feedback and begin the process of narrowing down the most important, fundable gaps that could be addressed through targeted research. Key stakeholders, including experts with lived patient experience, patient and disease advocacy groups, and other special interest groups, provided input via email, questionnaire, and informal phone interviews. These stakeholders came together for a meeting of the collaborative on July 30, 2019, to discuss and prioritize the gaps and barriers that should be included in a research agenda to advance the science of patient input. In 2020, collaborative participants will work toward the publication of this work. 15

Clinical Trial Site Standards Harmonization Mobilized in 2012, this action collaborative set out to explore opportunities to improve clinical trial site functioning with the goal of increasing productivity in medical product development. To date, the collaborative has drawn together a group of diverse stakeholders for four in-person meetings (December 2012, August 2013, March 2014, and September 2018). Collaborative participants published a National Academy of Medicine Discussion Paper in October 2017, which summarizes their perspectives on a proposed launching point for harmonizing the standards applied to clinical trial sites. In 2018, the collaborative collected, analyzed, and assessed a set of site standards used by industry sponsors to qualify sites for launching the majority of phase II, III, and IV clinical trials and consolidated them to create a harmonized set of baseline standards, which could be considered for broad application across clinical trial sites by research sponsors. In 2019, a working group of the collaborative produced an internal document that summarized the results of this activity and outlined a set of core harmonized clinical trial site standards. In 2020, collaborative participants will continue to socialize the site standards among key stakeholders and seek buy in for implementation. Improving the Drug Development Process Through Examining Late-Stage Failures Considering the burden on patients and the time and expense of clinical trials, the goal of this action collaborative is to examine the contributing factors toward late-stage failures in drug development and develop a set of key considerations for stakeholders to improve the probability of success. In 2018, collaborative participants conducted a series of structured informational interviews with respondents directly involved in late-stage therapeutic development, including representatives from government agencies, large biopharmaceutical companies, small biotechnology companies, health care investors, trade organizations, and nonprofit organizations. Responses were analyzed, synthesized, and supplemented by information compiled from a literature survey. The collaborative held a meeting on October 3, 2018, to discuss key themes and considerations for 16

Action Collaboratives evaluating late-stage product development. In 2020, collaborative participants will continue to work toward the publication of this work. Sharing Clinical Trial Data Sharing clinical trial data can help facilitate more efficient and effective development of better medicines, diagnostics, and procedures for the ultimate benefit of patients. At the same time, sharing data presents risks, burdens, and challenges that need to be addressed by a broad set of stakeholders. These opportunities and challenges were laid out in the IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, which calls on stakeholders to foster a culture of sharing and offers a blueprint for action within and across sectors. The Forum, along with the National Academies’ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, provided momentum and a framework for initiating the consensus study that produced the report and continue to work together to support coordination and collaboration among stakeholders engaged in data-sharing initiatives through convening and other activities. This action collaborative, in collaboration with Brigham and Women’s Hospital and Harvard University’s Multi-Regional Clinical Trials Center, helped inform the establishment of Vivli—a global data repository, Cloud-based analytics platform, and in-depth search engine. The public launch of Vivli took place at the National Academies on July 19, 2018. The action collaborative also worked to establish data-sharing goals for nonprofit funders of clinical trials. On November 30, 2017, the collaborative convened a meeting of leaders of nonprofit disease advocacy organizations, philanthropic organizations and foundations, federal government, academia, industry, and others to review a draft of the Statement of Data-Sharing Goals for Nonprofit Funders of Clinical Trials, discuss the associated risks and challenges with implementing the goals, and explore the next steps for operationalizing them. In 2020, collaborative participants will continue to work toward the publication of this statement of data-sharing goals. 17

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In 2019, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum), in collaboration with the National Academies’ National Cancer Policy Forum, hosted a meeting on Updating Labels for Generic Oncology Drugs, which provided a venue to examine the challenges and opportunities for updating labeling for generic oncology drugs. In collaboration with the National Academies’ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, the Forum hosted two workshops:

  • Enhancing Scientific Reproducibility Through Transparent Reporting, which explored issues related to transparent reporting (e.g., the disclosure of the availability and location of data, materials, analysis, and methodology) to improve rigor and reproducibility in biomedical research.
  • Sharing Clinical Trial Data: Challenges and a Way Forward, which examined progress, lessons learned, and remaining gaps in clinical trial data sharing and reuse following the publication of the 2015 Institute of Medicine report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.
For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation.

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