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Clinical Trials
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
The adaptive design may also be considered, with regulatory agency concurrence, for mid- and late-stage clinical trials of certain products. Adaptive design means that changes may be made in the design of a clinical study if such change is guided by examination of data, accumulated at a particular interim milestone. An adaptive design can reduce the duration of a study or decrease the total number of patients required, and because it is based on recent information and experience, it can enhance the value of data that are generated by study completion. Although the greatest interest in adaptive design has been with adequate and well-controlled late-stage (Phase 3) studies, this approach has also worked well with ascending-dose or other mid-stage studies. However, there are caveats. Adaptive clinical study designs are prospective and must be carefully considered with regulatory authorities before initiation. As noted above, the interim analysis on which change is based is itself carefully selected and protocol revisions are previously planned, and certain changes may not be acceptable under any circumstances. Nonetheless, given a wide range of acceptable design changes, the adaptive design offers numerous opportunities when properly planned and applied.
Architectural space classification considering topological and 3D visual spatial relations using machine learning techniques
Published in Building Research & Information, 2023
Berfin Yıldız, Gülen Çağdaş, Ibrahim Zincir
Floor plans are crucial components in the architectural design processes, construction phase and facility management throughout the building lifecycle. The designer allocates spatial features such as size, shape, location, lighting, etc. to determine usage definitions and these features are represented in two-dimensional floor plans. Digital-based technologies have expanded the capabilities of floor plan representation beyond merely transferring design information. Floor plan layouts are used for many purposes such as estimating spatial usability (Kearns, 2022; Özer & Jacoby, 2022), performing circulation analysis (Shin & Lee, 2019), making preliminary cost estimations (Cheung et al., 2012; Miraj et al., 2021) and evaluating energy consumptions (Du et al., 2020; Florides et al., 2002; Hernandez & Kenny, 2010). Although technological advances have increased the efficiency and effectiveness of these processes, there are several shortcomings that must be addressed over the building’s lifespan. During the design phase, buildings are often designed for specific functions, that limit their potential for future uses resulting the lack of adaptability. However, automating the recognition of room functions can be a solution to this issue by offering valuable insights into how spaces are used. Accurately defining the functions of the various spaces within a building allows architects and designers to optimize the use of space, and to design and test buildings to be more flexible in terms of usability. The concept of spatial adaptability is important in building design as it allows spaces to be used for multiple functions over time as user needs change. The importance of design for adaptive buildings stems from its potential to provide sustainable and circular solutions (Gosling et al., 2013). Adopting an adaptive design approach brings economic benefits by reducing future rebuilding costs. Also, from an environmental point of view, adaptability presents an opportunity for the long-term use of a building, avoiding underutilized spaces, costly renovations and waste due to increased material consumption (Slaughter, 2001). Adaptation is considered a crucial factor for promoting long-term social sustainability in residential buildings as well as environmental sustainability (Femenias & Geromel, 2020). It can contribute to an improvement in the quality of life for individuals by supporting cultural diversity and self-actualization (Boström, 2012).