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Oliver Lee
Oliver Lee

Phase 2: Planning


Sample size planning is an important design consideration for a phase 3 trial. In this paper, we consider how to improve this planning when using data from phase 2 trials. We use an approach based on the concept of assurance. We consider adjusting phase 2 results because of two possible sources of bias. The first source arises from selecting compounds with pre-specified favourable phase 2 results and using these favourable results as the basis of treatment effect for phase 3 sample size planning. The next source arises from projecting phase 2 treatment effect to the phase 3 population when this projection is optimistic because of a generally more heterogeneous patient population at the confirmatory stage. In an attempt to reduce the impact of these two sources of bias, we adjust (discount) the phase 2 estimate of treatment effect. We consider multiplicative and additive adjustment. Following a previously proposed concept, we consider the properties of several criteria, termed launch criteria, for deciding whether or not to progress development to phase 3. We use simulations to investigate launch criteria with or without bias adjustment for the sample size calculation under various scenarios. The simulation results are supplemented with empirical evidence to support the need to discount phase 2 results when the latter are used in phase 3 planning. Finally, we offer some recommendations based on both the simulations and the empirical investigations.




Phase 2: Planning



In this second and final phase of the Facilities Plan, we drew from the wealth of data collected in Phase 1 to envision our future college development. Little did we know when we started this work in 2020 that it would all need to be done virtually. With a focus on outreach and engagement through online surveys, focus groups, and remote workshops, along with an inquiry plan using a Critical Race Spatial Lens, we know what an important resource the college is to students. This qualitative input enriched our campus development plans and added a level of confidence to our future projections.


Moving forward, NYCT and NYC DOT will draw upon these studies in developing new BRT services based on available funding, community support, and progress on related transit projects. For each corridor, NYCT and NYC DOT will engage in an extensive community planning effort that will include outreach to residents, neighborhood groups, community boards, local elected officials, business groups, and other stakeholders.


During Phase 1, a life cycle model (LCM) was developed to evaluate the feasibility of reintroduction. This new LCM is like those used in Willamette River fish passage planning. During Phase 2, locally collected empirical data will replace LCM assumptions used in Phase 1. The LCM will be continually updated as results from Phase 2 studies are generated both annually and at the conclusion of individual research projects. Outputs from the LCM will then be used to refine studies; informing sample sizes required to meet desired levels of confidence, and the order in which studies and actions are carried out. Once all assumptions are replaced with locally derived data the LCM will provide measures of fish and population performance and allow for the testing of different management scenarios. A stepwise and adaptive management framework has been developed to collect the data necessary to resolve critical modeling uncertainties.


Adaptive management will occur during and between steps and sub-steps. Research projects will also be adaptively managed on an annual basis to improve results and performance metrics. At the conclusion of each study year, levels of statistical confidence and LCM outputs will be reviewed to inform modifications to the study design to improve results for the following study year (e.g., increase sample sizes) or subsequent study. Once the study is complete, performance metrics will guide decision-making by following decision flow charts (see Section 2.7). The decision flow charts for fish passage planning rely on several performance metrics: juvenile passage survival per dam and AR/S per associated production area and combined production. These performance metrics will initially be used to inform the sequence of installing interim fish passage facilities. As fish passage is provided at one project, RM&E will continue, and the updated performance metrics will guide the next action by following the subsequent flow chart.


Several concepts for upstream and downstream fish passage strategies were developed during Phase 1. These include both traditional passage techniques such as ladders and trap-and-haul, as well as emerging technologies such as floating surface collectors and pneumatic tubes. Little is known about fish behavior at each of the five dams, and therefore it is premature to subscribe to a particular passage strategy at an individual project. Instead, fish passage planning will follow the framework described in the U.S. Army Corps of Engineers (USACE) Surface Bypass Program Comprehensive Review Report (Compendium; USACE 2007). Research performed in Step 1, and continued throughout Phase 2, will be critical to guide how passage is prepared, interim facilities are developed, and eventually produced and operated.


Phase 2 is estimated to cost $183 million, with Step 1 estimated to cost $34 million and $149 million for Step 2. Research, monitoring, and evaluation is estimated to cost $74 million over the 21-year phase, with $109 million associated with infrastructure, operations, and maintenance. These estimates were made in 2020 and will periodically be adjusted for inflation.


In 2007, the City of Boulder completed the Transit Village Area Plan (TVAP) outlining the future for Boulder Junction, a 160-acre area located in the geographic center of Boulder, around 30th Street, Pearl Street, Valmont Road and Foothills Parkway. The plan anticipated the development of new transit facilities and established a vision for the area to evolve into a lively, mixed-use, pedestrian-oriented place where people will live, work, shop and access regional transportation. The plan identified two phases of development: Phase 1 for the area west of the existing railroad tracks and Phase 2 for the area east of the tracks.


Phase 2 planning looks at the future of Tomar Park and the changes coming in and around the park. One big factor that has impacted the Tomar neighborhood is the recent flooding in the Rose-Lotta neighborhood. A voluntary home buy-out program is currently in place to help owners of flooded homes relocate to drier ground over the next 10 years. The acquired property will eventually be included into a Tomar Park expansion. Another factor that will impact the park and surrounding areas is the future reconstruction of the Minnesota-I-229 interchange.


Preparedness takes the form of plans or procedures designed to save lives and to minimize damage when an emergency occurs. This is a continuous cycle of planning, organizing, training, equipping, exercising, evaluation and improvement activities to ensure effective coordination and the enhancement of capabilities to prevent, protect against, respond to, recover from and mitigate the effects of natural disasters, acts of terrorism and other man-made disasters. These activities ensure that when a disaster strikes, emergency managers will be able to provide the best response possible.


In the preparedness phase, emergency managers develop plans of action to manage and counter their risks and take action to build the necessary capabilities needed to implement such plans. Common preparedness measures include:


I am proud of the many successes we achieved over the past two years. The extraordinary contributions of our students, faculty, and staff have created a strong foundation to dive into the next phase of our strategic plan. In this document, you will learn about our accomplishments from Phase I and how that work evolves and continues into Phase II.


As we transition into this important second phase, I see a new level of excitement, optimism, and opportunity with the next set of key actions and tactics. These were developed with careful consideration of feedback from the university community, strategic priorities that university leaders identified, and opportunities to build on the good work from Phase I. The university community came together to engage in thoughtful discussions and offer valuable insight into Phase II of our strategic plan.


I appreciate everyone who shared their ideas about how we can continue our forward momentum. I invite each member of our university community to reflect on the key actions and tactics in this next phase, consider where there is alignment with your own work, and identify ways you will help realize our vision for UNC. As we diligently work together toward the 2030 outcomes, we will remain focused on our shared vision and common purpose as a Students First university. We will do this in how we serve students and foster their excellence as well as the excellence of our faculty and staff, the actions we take that reflect our deep commitment to equity and inclusion, our ability to innovate and inspire, and the strong partnerships we forge in our community and beyond.


Rowing, Not Drifting 2030 is a living document, divided into five two-year phases that will guide and establish a broad foundation for UNCto build upon. In 2020, the university transitioned from visioning work to establishing key actions and tactics for the first two years, ensuring institutional alignment with the strategic plan at all levels of the organization.


The university will track, measure, and report progress for each two-year phase, and the entire strategic plan. Every two years, the university will engage collectively in formulating new key actions and tactics for the next phase of the plan. These new key actions and tactics will build from the successes of the previous phase. Each member of the university will have opportunities to provide input, share ideas, and the expectation to contribute in meaningful ways in support of current and future key actions and tactics. In this manner, Rowing Not Drifting 2030 is not a document; rather, it is a process that is embedded in the UNC culture of continuous growth.


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