Internal Process: Strategic Principles
NCATS employees were engaged in the early stages of the Center’s strategic planning process to provide their perspectives on the fundamental characteristics that guide activities at NCATS, both current and aspirational. Through a series of small group discussion sessions, the opinions and insights of nearly all NCATS employees were gathered. These diverse perspectives contributed to the development of the request for external input as well as the final strategic principles that are presented in the NCATS Strategic Principles section.
Gathering External Input: Focus Groups
To identify the key strategic planning topics on which NCATS would seek public input, NCATS created a series of focus groups composed of NCATS researchers, program leaders, other staff, and members of NCATS’ two advisory committees: the Advisory Council and the Cures Acceleration Network (CAN) Review Board. Each focus group was asked to identify priorities and challenges in each of six pre-defined overarching areas of NCATS’ research and operational activities. These focus areas were: Pre-Clinical Innovation — Improving the Drug Development Process; Pre-Clinical Innovation — Testing and Predictive Models; Repurposing Drugs; Re-Engineering the Clinical and Translational Process; Accelerating and Supporting Rare Diseases Research; and Building Partnerships with Stakeholder Groups. All focus groups also were asked to consider two cross-cutting questions: (1) how NCATS could more effectively engage with patients and community members in each phase of translation, and (2) how the strategic plan should address the role of “big data” and informatics in translational science.
Stakeholder Engagement: RFI and Webinars
After receiving additional input from NCATS Advisory Council and CAN Review Board members at a public meeting in early September 2015, NCATS launched the stakeholder engagement phase of the strategic planning process in October 2015 to solicit feedback from the broader public. The goal of this phase was to identify areas of opportunity, challenges and research needs in translational science to help set the Center’s strategic priorities. NCATS’ stakeholders include, but are not limited to, patients and members of the health advocacy community; basic, translational and clinical scientists at universities and research institutions; health care providers; biotechnology, venture capital and pharmaceutical industry members; colleagues at other NIH Institutes, Centers and Offices; partners at other government agencies (e.g., the Food and Drug Administration and other Department of Health and Human Services agencies, the Environmental Protection Agency, and the Department of Defense); policymakers; and the general public.
A public request for information (RFI) and a series of four “town hall” webinars were the principal vehicles used to solicit feedback from these individuals and groups. The RFI was publicly disseminated in October 2015 and was open for comment until February 2016, and the public informational webinars took place in October and November 2015. Through the RFI, NCATS encouraged stakeholders to comment on any issues of interest that apply across the translational science spectrum, including:
- Breaking down professional, cultural and scientific silos across the translational science spectrum
- Focusing on inter-operability of data systems (such as integrating patient data and electronic health records into pre-clinical research)
- Expanding research efforts at NCATS into new therapeutic modalities
- Focusing on patient-driven research and patient/community engagement
- Forming innovative partnerships with a wide variety of stakeholders
- Identifying skillsets and competencies needed for training the next generation of translational scientists
- Using modern communication and dissemination tools to expand awareness of translational science to a wide variety of stakeholders
NCATS received 54 responses to the RFI from individuals, organizations and institutions representing academia, government, industry, patient advocates, and health care providers. A total of 119 unique participants from around the country and across multiple sectors signed into the webinars to learn more about the NCATS strategic planning process and how best to contribute comments about the Center’s strategic priorities via the RFI. The analysis of RFI responses involved carefully reviewing each response, along with any attached supplementary materials, and identifying specific recommendations and actionable items provided. The responses addressed a broad array of priority issues across both the scientific and operational domains of translation, and directly informed the development of the objectives and example approaches within each strategic goal.