Attachment_8_TO__3.docx

SENTINEL INITIATIVE

ATTACHMENT 8

TASK ORDER #3: COMMUNITY BUILDING AND OUTREACH CENTER TASK ORDER

STATEMENT OF WORK

Table of Contents

Project Title: Sentinel Initiative – Community Building and Outreach Center (CBOC) Task Order

1. Introduction In the Sentinel System’s Five-Year Strategy[footnoteRef:2], FDA set forth a strategic objective to “Expand the Sentinel System by facilitating its use by other stakeholders, and foster innovation and development.” Within this objective were two key aims: [2: https://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM629243.pdf]

1. Create a national resource by broadening the Sentinel user base

2. Disseminate knowledge and advance regulatory science Although many stakeholders already engage with the Sentinel System, FDA is committed to deepening their involvement and broadening awareness, access, and use of Sentinel System tools and data infrastructure. Expanding access and use is valuable because it can accelerate the development of new methods and technological innovations, and lead to novel uses of the system. Opening Sentinel to a wider user base may help ensure system sustainability and heightens the likelihood that insights will translate into public health actions that benefit patients. Through this Task Order, FDA is establishing the Sentinel Community Building and Outreach Center to provide a center of excellence with the capacity to:

· Engage directly with potential end-users and develop a Sentinel scientific community

· Estabish or improve novel public-facing interfaces for accessing Sentinel tools, methods and results

· Create an online, open-source tool development platform where source code can be viewed, inspected, modified and enhanced over time

· Identify common needs and aims across groups of end users, including data visualization and descriptive tools, strategies to overcome data sharing barriers, common data quality metrics for multi-site networks, technologies to improve inter-network communications, and developing common data standards

· Convene public workshops with active and potential Sentinel System end users (e.g., pharmaceutical industry, healthcare payors and providers, and academics) to identify needs and share best practices

· Host challenges to translate the existing Sentinel analytic tools into different programming languages to appeal to a broader user base

· Convene scientific competitions and challenge events to spur innovation and community involvement

· Develop approaches to enable easier exploration and adaptation of the Sentinel tools for specific end user needs

· Identify and communicate how the capabilities of the Sentinel System can be used for other purposes in the Learning Healthcare System The Sentinel Community Building and Outreach Center is distinguished from the Operations Center and the Innovation Center in that the focus is outreach, communication, convening, and collaboration, rather than network operations or methods development. The ideal contractor shall have strong faculties in the essential epidemiologic, data analysis, and public health sciences, but also possess advanced knowledge, skills and capabilities in the fields of public relations, health communications, and marketing to nurture and catalyze community building.

2. Objectives This Task Order is issued under the Sentinel Initiative IDIQ contract to establish and maintain a Community Building and Outreach Center (CBOC). The CBOC will be responsible for creating engagement and disseminate knowledge to organizations outside of the OC and IC networks to promote and cultivate a broader Sentinel user community with the purpose of expanding the Sentinel System. To this end, this task order includes the following program tasks:

· Task 1: Community Building and Outreach Center

· Task 2: Master Plan for Support and Expansion of the Sentinel User Community

· Task 3: Sentinel Community Building Activities

3. Task 1: Community Building and Outreach Center (CBOC) The Community Building and Outreach Center (CBOC) is responsible for creating engagement and disseminate knowledge to organizations outside of the OC and IC networks to promote and cultivate a broader Sentinel user community with the purpose of expanding the understanding and use of the Sentinel System’s infrastructure and tools to address a wide-range of healthcare problems and creating the opportunity for a broad group of interested stakeholders to contribute to building the Sentinel System’s capabilities.

3.1. Establishment and Maintenance of the Community Building and Outreach Center The Contractor shall establish a Leadership Team to oversee all aspects of operations for the CBOC. The CBOC Leadership Team shall create the organizational structure, administrative processes and governance for the CBOC and its network of scientific collaborators. The CBOC Leadership Team shall interface routinely with the FDA Sentinel Core Team, FDA Senior Leadership Team, Sentinel OC and Sentinel IC. In collaboration with FDA, the CBOC Leadership Team shall participate in strategic development planning. The CBOC Leadership Team shall meet programmatic goals and oversee contract deliverables, finances and program management activities.

The CBOC shall build and maintain a diverse team with expertise in epidemiology, clinical medicine, pharmacy, statistics, health informatics, data science (specifically, artificial intelligence (natural language processing, machine learning)), training, health communications and community building to achieve the goals of this requirement.

3.2. Communication with Stakeholders and Scientific Collaboration The CBOC shall develop and maintain open communications with stakeholders and promote scientific collaborations. In collaboration with FDA, the OC and the IC, the CBOC shall provide content related to CBOC activities for inclusion in the Sentinel Initiative website and online public developer community website. This content might include training resources developed by the CBOC used to educate and train interested members of the academic community, consumers, and the public, about the Sentinel infrastructure and tools to address a wide-range of healthcare problems. The CBOC might also provide information on scientific challenges (i.e., competition) to address specific needs of the FDA and other stakeholders.

4. Task 2: Master Plan for Support and Expansion of the Sentinel User Community The CBOC shall develop a master plan for supporting and expanding the community of Sentinel System users, including the use of training, outreach, and scientific challenges (i.e., competition) to address specific needs of the FDA and other stakeholders. The master plan shall take approximately 12 months to develop and be jointly authored with FDA, unless otherwise agreed upon with FDA. The master plan shall outline a sequence of discrete, realistic, feasible and executable projects expand and support a scientific community within a five-year time frame. The master plan shall balance anticipated costs and benefits of a comprehensive set of outreach activities to create the highest impact strategy to achieve FDA’s aims. In developing the plan, the CBOC should draw upon previous experience and illustrate anticipated deliverables and outcomes using previously successful initiatives of similar scope or target audience. The master shall plan shall also include approaches to monitor and measure the effectiveness of the community building activities across the five-years of implementation. Such measures may include but are not limited to: end-user satisfaction survey results, quantities of publications of use cases beyond drug safety surveillance, new analysis tools crafted as a result of open source development platforms, evidence of vigorous and extensive engagement within online communities, and increasing adoption of the SCDM. The master plan shall also be multimodal to incentivize collaboration in both in-person and online communities, and may include selective engagement of opinion- and thought-leaders in key disciplines and organizations.

Training and community building: The master plan shall contain a plan for training targeting members of the academic community, consumers and the public (i.e. stakeholder groups other than FDA, FDA-regulated industry, other federal agencies, and international regulators) to enhance understanding of the Sentinel System and encourage use of the Sentinel tools and SCDM by groups outside the Sentinel System. Specific tasks include:

· Identifying key training needs of stakeholder groups based on the Master Plan (section 3.2)

· Develop training plans focused on up to 3 key stakeholder groups

· Training plan should consist of

· Lesson background Materials

· Qualified instructors

· Training course materials

· Course evaluation

· Recording and dissemination of training through electronic media

Scientific challenges: The CBOC shall develop a plan to perform all aspects of a challenge program related to use of the SCDM and Sentinel tools to address a wide-range of healthcare problems and creating the opportunity for a broad group of interested stakeholders to contribute to building the Sentinel System’s capabilities. The plan for competitions shall include timelines, processes, rules, terms and conditions, legal framework, intellectual property requirements, questions, descriptions, and marketing strategy capable of achieving high visibility. The plan shall also include approaches to judging criteria, identifying collaborating parties, running the competition, and a post-competition phase including collecting feedback from stakeholders, promoting the competition findings and results, and following up with winners and finalists.

Integrating input from broader stakeholder community into Sentinel production system: The CBOC shall describe a plan for how input from the broader stakeholder community including members of academic community, consumers and the public (i.e. stakeholder groups other than FDA, FDA-regulated industry, other federal agencies, and international regulators), will be evaluated for potential incorporation into the Sentinel production system. The plan shall describe a collaborative approach including the FDA, the IC, and OC and include the outline of a process for moving input from the idea to implementation. The plan shall account for at least the following types of input:

· Results of scientific challenges

· Software and other information posted to the public access site (e.g. Github.com)

· Feedback from training programs and other outreach activities

5. Task 3: Sentinel Community Building Activities FDA will issue Work Orders to complete the activities outlined in the Master Plan, following its completion. CBOC community building activities may include, but are not limited to any of the following:

· The CBOC shall advance the dissemination, training, and adoption of the Sentinel platform and obtain feedback on user experience.

· Stakeholder meetings: The CBOC in collaboration with the FDA, OC and IC shall convene stakeholder groups across the healthcare ecosystem to seek expert input and shape new approaches to explore high-priority innovation use cases, conduct demonstration projects, publish results and share insights in the topic areas of interest to FDA

· Training and community building: The CBOC shall promote the Sentinel Initiative at up to 3 major meetings to reach the communities identified in the Master Plan.

· Scientific challenges: In collaboration with FDA, OC and the IC, the CBOC shall design and conduct at most one (1) technical competition per year.

· The CBOC shall work collaboratively with FDA, OC and IC to integrate any methods or tools developed by the broader scientific community into the Sentinel production system.

FDA is not obligated to fund any project within the Master Plan and reserves the right to issue Work Orders for projects not listed in the Master Plan.

6. Period of Performance