Family Homemaking Tactics in Tyneside Flats: Contemporary Interpretations of Victorian Domestic Interior

In an adaptive trial, the researcher may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing the study focus or increasing the number of subjects, balancing treatment allocation or different forms of randomization based on responses of subjects prior to treatment. This research aims at compiling the technical, statistical, and regulatory implications of the employment of adaptive design in a clinical trial. Review of adaptive design clinical trials in Medline, PubMed, EU Clinical Trials Register, and ClinicalTrials.gov. Phase I and seamless phase I/II trials were excluded. We selected variables extracted from trials that included basic study characteristics, adaptive design features, size and use of independent data-monitoring committees (DMCs), and blinded interim analysis. The research retrieved 336 results, from which 78 were selected for analysis. Sixty-seven were published articles, and 11 were guidelines, papers, and regulatory bills. The most prevalent type of adaptation was the seamless phase II/III design 23.1%, followed by adaptive dose progression 19.2%, pick the winner / drop the loser 16.7%, sample size re-estimation 10.3%, change in the study objective 9.0%, adaptive sequential design 9.0%, adaptive randomization 6.4%, biomarker adaptive design 3.8%, and endpoint adaptation 2.6%. Discussion DISCUSSION: It is possible to infer that the use of Adaptive Design is an ethical and scientific advantage when properly planned and applied, since it increases the flexibility of the trial, shortens the overall clinical investigation time of a drug, and reduces the risk of patient exposure to adverse effects related to the experimental drug. Its greater methodologic and analytic complexity requires an adequate statistical methodology. The application of "adaptive clinical designs" for phase II/III studies appear to have been limited to trials with a small number of study centers, with smaller extensions of time and to experimental drugs with more immediate clinical effects that are amenable to risk/benefit decisions based on interim analyses. According to the reviewed studies, simple adaptive trial designs-such as early study terminations due to futility and sample size re-estimation-are becoming widely adopted throughout the pharmaceutical industry, especially in phase II and III studies. The pharmaceutical industry and contract research organizations (CROs) are implementing simple adaptations more frequently and the more complex adaptations-biomarker adaptive design, endpoint adaptation-are more sporadic.

Guidelines for disassembly and adaptation in architectural design compared to circular economy goals - A literature review

A landscape of methodology and implementation of adaptive designs in cancer clinical trials

ObjectivesThis review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials.DesignReview of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of...

In an adaptive trial, the researcher may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing the study focus or increasing the number of subjects, balancing treatment allocation or different forms of randomization based on responses of subjects prior to treatment. This research aims at compiling the technical, statistical, and regulatory implications of the employment of adaptive design in a clinical trial. Review of adaptive design clinical trials in Medline, PubMed, EU Clinical Trials Register, and ClinicalTrials.gov . Phase I and seamless phase I/II trials were excluded. We selected variables extracted from trials that included basic study characteristics, adaptive design features, size and use of independent data-monitoring committees (DMCs), and blinded interim analysis. The research retrieved 336 results, from which 78 were selected for analysis. Sixty-seven were published articles, and 11 were guidelines, papers, and regulatory bills. The most prevalent type of adaptation was the seamless phase II/III design 23.1%, followed by adaptive dose progression 19.2%, pick the winner / drop the loser 16.7%, sample size re-estimation 10.3%, change in the study objective 9.0%, adaptive sequential design 9.0%, adaptive randomization 6.4%, biomarker adaptive design 3.8%, and endpoint adaptation 2.6%. It is possible to infer that the use of Adaptive Design is an ethical and scientific advantage when properly planned and applied, since it increases the flexibility of the trial, shortens the overall clinical investigation time of a drug, and reduces the risk of patient exposure to adverse effects related to the experimental drug. Its greater methodologic and analytic complexity requires an adequate statistical methodology. The application of "adaptive clinical designs" for phase II/III studies appear to have been limited to trials with a small number of study centers, with smaller extensions of time and to experimental drugs with more immediate clinical effects that are amenable to risk/benefit decisions based on interim analyses. According to the reviewed studies, simple adaptive trial designs-such as early study terminations due to futility and sample size re-estimation-are becoming widely adopted throughout the pharmaceutical industry, especially in phase II and III studies. The pharmaceutical industry and contract research organizations (CROs) are implementing simple adaptations more frequently and the more complex adaptations-biomarker adaptive design, endpoint adaptation-are more sporadic.

From case studies of highly capitalized, architect-designed buildings confronted by natural and manmade disasters of the last decade, this paper extracts exemplary cases ofmitigation, adaption, transformation design (before, during, and after) disaster instances globally. Based on resilience attributes from biology and complexity theories (Zolli and Healy,2012), these cases, prepared with graduate students in courses on resilience and research methods, examine attributes that map onto architecture (i.e., simple cores/complex edges, modularity, etc.). Cases question how architects and designers can begin to address other resilience attributes that architecture does not (i.e. capacity for flocking/swarming). Disaster mitigation strategies of Ito and Suzuki in Sendai, Japan, adaptation design with shipping containers during 5000 earthquakes aftershocks period (2011-2012) in Christchurch, New Zealand, and transformative design strategies that changed the identity of Greensburg, Kansas via LEED designed buildings are cases abbreviated in the paper. Third, architects’ roles before and after disasters have become well defined. In contrast, roles during disasters are absent from the literature and practice of architecture. Efforts to better ascertain critical roles for architects during relatively predictable disaster events (i.e. hurricanes, wildfire, storm surge, sea level rise, etc.) are next.

Increased timber construction is putting pressure on Ireland’s limited structural-grade timber stock, while recovered timber is currently downcycled or incinerated. Design for Adaptability, disassembly and reuse (DfADR) has emerged as a response to this wasteful linear process, which can increase the life span of structures, the ease of disassembly during and after use, and improve the quality of recovered material. However, while many DfADR strategies have been identified, uptake in architectural practice is lacking. Impediments to DfADR were identified through an analysis of an existing timber-framed structure and a modified design developed based on the ISO 20887:2020 principles to illustrate practical solutions. In tandem, a decision tool was developed that organised the plethora of identified strategies by the ISO principles and the work stages used by designers to facilitate integration into practice. Modest reconfigurations of the space and roof structure increased adaptability, access to services for replacement and repair, and expansion potential to increase service life, while rationalized timber sizes improved reuse potential. Using wood nails in stud and joist framing, with screws replacing nails elsewhere, and omitting adhesives from the floor panels increased the ease of disassembly. These relatively minor changes resulted in nearly 3 times the amount of solid timber with a high reuse potential (≥2348 mm) recovered over the original design, highlighting the impact DfADR can have on the recoverability and reusability of timber.

Inclusion of adaptive design features in a clinical trial provides preplanned flexibility to dynamically modify a trial during its conduct while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology. Stroke is a natural candidate for adoption of these innovative approaches to trial design. This Research Methods in Neurology article is informed by a scoping review that identified 45 completed or ongoing adaptive clinical trials in stroke that were appraised: 15 trials had published results with or without a published protocol and 30 ongoing trials (14 trials had a published protocol, and 16 trials were registered only). Interventions spanned acute (n = 28), rehabilitation (n = 8), prevention (n = 8), and rehabilitation and prevention (n = 1). A subsample of these trials was selected to illustrate the utility of adaptive design features and discuss why each adaptive feature was incorporated in the design to best achieve the aim; whether each individual feature was used and whether it resulted in expected efficiencies; and any learnings during preparation, conduct, or reporting. We then discuss the operational, ethical, and regulatory considerations that warrant careful consideration during adaptive trial planning and reflect on the workforce readiness to deliver adaptive trials in practice. We conclude that adaptive trials can be designed, funded, conducted, and published for a wide range of research questions and offer future directions to support adoption of adaptive trial designs in stroke and neurologic research more broadly.

Mindy Scheier, a former fashion designer and mother of a child with a disability, developed adaptive apparel design innovations focused on three categories: (a) magnetic closures; (b) adjustable pant legs, sleeves, and waistband; and (c) the flexibility of donning and doffing using different points of entry. The adaptive design features were incorporated into a first-of-its-kind adaptive children’s wear line collaboration with Tommy Hilfiger® in 2016. Scheier’s adaptive design features and her collaboration with Tommy Hilfiger® were well documented and have influenced additional adaptive apparel lines in mainstream fashion. The goal of this study was to gain an in-depth and contextualized understanding of Scheier’s design process to determine how she developed her adaptive apparel design innovations using a user-focused approach. To achieve this goal, a case study was deployed. This study revealed that Scheier included the PWD (people with disabilities) user in every stage of her design process by building trust and allyship with the PWD population. Further, Scheier had to balance the needs of the PWD user with that of the apparel industry to ensure her adaptive design features were included in mainstream apparel.

This study investigated the potential of inclusively designed adaptive apparel discovered within a historic costume and textile collection to inspire contemporary inclusive and adaptive apparel design in a product development course. This study employed object-based learning as the theoretical framework, focusing on the tangible examination and analysis of historical garments as educational tools. A descriptive analysis qualitative methodology was used to identify the key inclusive adaptive apparel design features that could potentially inform inclusively designed adaptive apparel in the present day. By examining a diverse range of historical garments, this study aimed to uncover design elements that transcend time and cultural contexts, providing valuable insights for contemporary product development students seeking to create inclusively designed adaptive apparel collections. The findings from this study suggest that historic costume and textile collections are a compatible and significant source for integrating inclusive design features into the apparel design classroom.

Transformative or Tokenistic?

The possibilities of stopping a clinical study earlier based on interim study results or to adjust the sample size during the study conduct are attractive features of adaptive clinical study designs. Herein, we present a survey summary of bioequivalence (BE) studies with adaptive designs in abbreviated new drug applications (ANDAs), reflecting the current status of its utility in generic drug development.

Although the efficiency of adaptive design on the trial level is well recognized, its impact is even greater when applied at the program or portfolio level. Besides its simplest form of sample size reestimation or early stopping in a given trial, the adaptive design achieves efficiency by combining in a single trial objectives that are usually addressed in two separate conventional studies. Another feature of adaptive design is population enrichment where drug response can be optimized to specific patient subpopulations that respond better to treatment. More complex adaptive strategies integrate the development of several compounds and/or indications into one process. We provide an overview of these types of adaptive designs and illustrate their value added in a case study of an adaptive “compound” finder that investigates several compounds in Alzheimer’s disease area simultaneously approaching the proof-of-concept stage.

There is considerable interest among pharmaceutical and other medical product developers in adaptive clinical trials, in which knowledge learned during the course of a trial affects ongoing conduct or analysis of the trial. When the FDA released a draft Guidance document on adaptive design clinical trials in early 2010, expectations were high that it would lead to an increase in regulatory submissions involving adaptive design features, particularly for confirmatory trials. A 6-year (2008-2013) retrospective survey was performed within the Center for Biologics Evaluation and Research (CBER) at the FDA to gather information regarding the submission and evaluation of adaptive design trial proposals. We present an up-to-date summary of adaptive design proposals seen in CBER and provide an overview of our experiences. We share our concerns regarding the statistical issues and operational challenges raised during the review process for adaptive design trials. We also provide general recommendations for developing proposals for such trials. Our motivation in writing this paper was to encourage the best study design proposals to be submitted to CBER. Sometimes these can be adaptive, and sometimes a simpler design is most efficient.

Recently, survey methodology literature has put forward responsive and adaptive survey designs as means to make efficient tradeoffs between survey quality and survey costs. The designs, however, restrict quality-cost assessments to nonresponse error, while there are various design features that impact also measurement error, e.g. the survey mode, the type of questionnaire (long or condensed) and the type of reporting (self or proxy). Extension of adaptive survey design to measurement error is, however, not straightforward when a survey has many and diverse survey items. An adaptive survey design needs to make an overall choice of design features that applies to all survey items simultaneously. In this paper, we investigate adaptive survey designs that account for both nonresponse and measurement error. In order to do so, we model the underlying causes for differences in measurement error between design features. This leads to response styles or response latencies. We tailor efforts so that either response style propensities are minimized or constrained. We illustrate the ideas with a case study on the 2008 Dutch Labor Force Survey. The design features in this study are the type of reporting (self-reporting only versus proxy-reporting allowed), and the number of face-to-face calls.