Relevant bibliographies by topics / Adaptive trial

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Adaptive trial'

Author: Grafiati
Published: 9 March 2023
Last updated: 10 March 2023

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Journal articles on the topic "Adaptive trial"

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Cellamare, Matteo, Steffen Ventz, Elisabeth Baudin, Carole D. Mitnick, and Lorenzo Trippa. "A Bayesian response-adaptive trial in tuberculosis: The endTB trial." Clinical Trials 14, no. 1 (September 23, 2016): 17–28. http://dx.doi.org/10.1177/1740774516665090.

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Purpose: To evaluate the use of Bayesian adaptive randomization for clinical trials of new treatments for multidrug-resistant tuberculosis. Methods: We built a response-adaptive randomization procedure, adapting on two preliminary outcomes for tuberculosis patients in a trial with five experimental regimens and a control arm. The primary study outcome is treatment success after 73 weeks from randomization; preliminary responses are culture conversion at 8 weeks and treatment success at 39 weeks. We compared the adaptive randomization design with balanced randomization using hypothetical scenarios. Results: When we compare the statistical power under adaptive randomization and non-adaptive designs, under several hypothetical scenarios we observe that adaptive randomization requires fewer patients than non-adaptive designs. Moreover, adaptive randomization consistently allocates more participants to effective arm(s). We also show that these advantages are limited to scenarios consistent with the assumptions used to develop the adaptive randomization algorithm. Conclusion: Given the objective of evaluating several new therapeutic regimens in a timely fashion, Bayesian response-adaptive designs are attractive for tuberculosis trials. This approach tends to increase allocation to the effective regimens.
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Lai, Tze Leung, Philip William Lavori, and Mei-Chiung Shih. "Adaptive Trial Designs." Annual Review of Pharmacology and Toxicology 52, no. 1 (February 10, 2012): 101–10. http://dx.doi.org/10.1146/annurev-pharmtox-010611-134504.

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Chen, Zhengjia, Yichuan Zhao, Ye Cui, and Jeanne Kowalski. "Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials." Journal of Probability and Statistics 2012 (2012): 1–20. http://dx.doi.org/10.1155/2012/527351.

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The clinical trial, a prospective study to evaluate the effect of interventions in humans under prespecified conditions, is a standard and integral part of modern medicine. Many adaptive and sequential approaches have been proposed for use in clinical trials to allow adaptations or modifications to aspects of a trial after its initiation without undermining the validity and integrity of the trial. The application of adaptive and sequential methods in clinical trials has significantly improved the flexibility, efficiency, therapeutic effect, and validity of trials. To further advance the performance of clinical trials and convey the progress of research on adaptive and sequential methods in clinical trial design, we review significant research that has explored novel adaptive and sequential approaches and their applications in Phase I, II, and III clinical trials and discuss future directions in this field of research.
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Chow, Shein-Chung. "Adaptive Clinical Trial Design." Annual Review of Medicine 65, no. 1 (January 14, 2014): 405–15. http://dx.doi.org/10.1146/annurev-med-092012-112310.

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May Lee, Kim, and J. Jack Lee. "Evaluating Bayesian adaptive randomization procedures with adaptive clip methods for multi-arm trials." Statistical Methods in Medical Research 30, no. 5 (March 10, 2021): 1273–87. http://dx.doi.org/10.1177/0962280221995961.

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Bayesian adaptive randomization is a heuristic approach that aims to randomize more patients to the putatively superior arms based on the trend of the accrued data in a trial. Many statistical aspects of this approach have been explored and compared with other approaches; yet only a limited number of works has focused on improving its performance and providing guidance on its application to real trials. An undesirable property of this approach is that the procedure would randomize patients to an inferior arm in some circumstances, which has raised concerns in its application. Here, we propose an adaptive clip method to rectify the problem by incorporating a data-driven function to be used in conjunction with Bayesian adaptive randomization procedure. This function aims to minimize the chance of assigning patients to inferior arms during the early time of the trial. Moreover, we propose a utility approach to facilitate the selection of a randomization procedure. A cost that reflects the penalty of assigning patients to the inferior arm(s) in the trial is incorporated into our utility function along with all patients benefited from the trial, both within and beyond the trial. We illustrate the selection strategy for a wide range of scenarios.
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Mawocha, Samkeliso C., Michael D. Fetters, Laurie J. Legocki, Timothy C. Guetterman, Shirley Frederiksen, William G. Barsan, Roger J. Lewis, Donald A. Berry, and William J. Meurer. "A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network." Clinical Trials 14, no. 3 (January 31, 2017): 246–54. http://dx.doi.org/10.1177/1740774516688900.

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Background: Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. Methods: We used an ethnographic, qualitative approach to evaluate key stakeholders’ views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths–Weaknesses–Opportunities–Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders’ responses to develop a conceptual model. Results: Four major overarching themes emerged during the analysis of stakeholders’ responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. Conclusion: The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.
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Trippa, Lorenzo, Eudocia Q. Lee, Patrick Y. Wen, Tracy T. Batchelor, Timothy Cloughesy, Giovanni Parmigiani, and Brian M. Alexander. "Bayesian Adaptive Randomized Trial Design for Patients With Recurrent Glioblastoma." Journal of Clinical Oncology 30, no. 26 (September 10, 2012): 3258–63. http://dx.doi.org/10.1200/jco.2011.39.8420.

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Purpose To evaluate whether the use of Bayesian adaptive randomized (AR) designs in clinical trials for glioblastoma is feasible and would allow for more efficient trials. Patients and Methods We generated an adaptive randomization procedure that was retrospectively applied to primary patient data from four separate phase II clinical trials in patients with recurrent glioblastoma. We then compared AR designs with more conventional trial designs by using realistic hypothetical scenarios consistent with survival data reported in the literature. Our primary end point was the number of patients needed to achieve a desired statistical power. Results If our phase II trials had been a single, multiarm trial using AR design, 30 fewer patients would have been needed compared with a multiarm balanced randomized (BR) design to attain the same power level. More generally, Bayesian AR trial design for patients with glioblastoma would result in trials with fewer overall patients with no loss in statistical power and in more patients being randomly assigned to effective treatment arms. For a 140-patient trial with a control arm, two ineffective arms, and one effective arm with a hazard ratio of 0.6, a median of 47 patients would be randomly assigned to the effective arm compared with 35 in a BR trial design. Conclusion Given the desire for control arms in phase II trials, an increasing number of experimental therapeutics, and a relatively short time for events, Bayesian AR designs are attractive for clinical trials in glioblastoma.
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Lauffenburger, Julie C., Niteesh K. Choudhry, Massimiliano Russo, Robert J. Glynn, Steffen Ventz, and Lorenzo Trippa. "Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations." BMJ Medicine 1, no. 1 (July 2022): e000158. http://dx.doi.org/10.1136/bmjmed-2022-000158.

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Randomised controlled clinical trials are widely considered the preferred method for evaluating the efficacy or effectiveness of interventions in healthcare. Adaptive trials incorporate changes as the study proceeds, such as modifying allocation probabilities or eliminating treatment arms that are likely to be ineffective. These designs have been widely used in drug discovery studies but can also be useful in health services and implementation research and have been minimally used. In this article, we use an ongoing adaptive trial and two completed parallel group studies as motivating examples to highlight the potential advantages, disadvantages, and important considerations when using adaptive trial designs in health services and implementation research. We also investigate the impact on power and the study duration if the two completed parallel group trials had instead been conducted using adaptive principles. Compared with traditional trial designs, adaptive designs can often allow the evaluation of more interventions, adjust participant allocation probabilities (eg, to achieve covariate balance), and identify participants who are likely to agree to enrol. These features could reduce resources needed to conduct a trial. However, adaptive trials have potential disadvantages and practical aspects that need to be considered, most notably: outcomes that can be rapidly measured and extracted (eg, long term outcomes that take considerable time to measure from data sources can be challenging), minimal missing data, and time trends. In conclusion, adaptive designs are a promising approach to help identify how best to implement evidence based interventions into real world practice in health services and implementation research.
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Berry, Donald A., Scott Berry, Peter Hale, Leah Isakov, Andrew W. Lo, Kien Wei Siah, and Chi Heem Wong. "A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates." PLOS ONE 15, no. 12 (December 23, 2020): e0244418. http://dx.doi.org/10.1371/journal.pone.0244418.

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We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 756 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.
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Freidlin, Boris, and Edward L. Korn. "Biomarker-adaptive clinical trial designs." Pharmacogenomics 11, no. 12 (December 2010): 1679–82. http://dx.doi.org/10.2217/pgs.10.153.

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Dissertations / Theses on the topic "Adaptive trial"

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Scarale, M. G. "RESPONSE - ADAPTIVE CLINICAL TRIALS." Doctoral thesis, Università degli Studi di Milano, 2015. http://hdl.handle.net/2434/344736.

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The question we posed at the beginning of this thesis was whether, in the presence of a clinical superiority of one of two possible treatments, it was possible to find an appropriate statistical methodology that would allow us to reach this goal. We were thus led to explore many possibilities to carry out this analysis and randomly assign patients to the two treatments, as required by the particular nature of these experiments. Specifically, we made a close examination of the methods of randomization, especially appreciating the flexibility of the adaptive responses, and could see the strengths of urn models. We started with the study of the urn for excellence, Polya's urn. Next, we analyzed some extensions and generalizations, focusing especially on two kinds of urns with random reinforcement. We exposed the results obtained throughout simulations concerning the convergence of the proportion of the best treatment, which came from the comparison of the models studied. In the end, we showed how the urn model works in a real case, comparing two treatments with continuous response in one ICU trial on Melatonin. We'll see how the properties demonstrated in theory are confirmed in practice. The project ends by giving a hint of a new adaptive model that we have started to idealize in collaboration with the team of Prof. Parmigiani and Prof. Trippa of the "Biostatistics and Computational Biology" Department, Harvard T.H. Chan School of Public Health.
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McCallum, Emma Clare. "Adaptive phase II clinical trial design using nonlinear dose-response models." Thesis, University of Cambridge, 2015. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.709013.

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Di, Pace Brian S. "Site- and Location-Adjusted Approaches to Adaptive Allocation Clinical Trial Designs." VCU Scholars Compass, 2019. https://scholarscompass.vcu.edu/etd/5706.

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Response-Adaptive (RA) designs are used to adaptively allocate patients in clinical trials. These methods have been generalized to include Covariate-Adjusted Response-Adaptive (CARA) designs, which adjust treatment assignments for a set of covariates while maintaining features of the RA designs. Challenges may arise in multi-center trials if differential treatment responses and/or effects among sites exist. We propose Site-Adjusted Response-Adaptive (SARA) approaches to account for inter-center variability in treatment response and/or effectiveness, including either a fixed site effect or both random site and treatment-by-site interaction effects to calculate conditional probabilities. These success probabilities are used to update assignment probabilities for allocating patients between treatment groups as subjects accrue. Both frequentist and Bayesian models are considered. Treatment differences could also be attributed to differences in social determinants of health (SDH) that often manifest, especially if unmeasured, as spatial heterogeneity amongst the patient population. In these cases, patient residential location can be used as a proxy for these difficult to measure SDH. We propose the Location-Adjusted Response-Adaptive (LARA) approach to account for location-based variability in both treatment response and/or effectiveness. A Bayesian low-rank kriging model will interpolate spatially-varying joint treatment random effects to calculate the conditional probabilities of success, utilizing patient outcomes, treatment assignments and residential information. We compare the proposed methods with several existing allocation strategies that ignore site for a variety of scenarios where treatment success probabilities vary.
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Mauldin, Jo A. Seaman John Weldon. "Bayesian approaches to problems in drug safety and adaptive clinical trial designs." Waco, Tex. : Baylor University, 2008. http://hdl.handle.net/2104/5177.

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Leininger, Thomas J. "An Adaptive Bayesian Approach to Dose-Response Modeling." Diss., CLICK HERE for online access, 2009. http://contentdm.lib.byu.edu/ETD/image/etd3325.pdf.

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Stacey, Andrew W. "An Adaptive Bayesian Approach to Bernoulli-Response Clinical Trials." CLICK HERE for online access, 2007. http://contentdm.lib.byu.edu/ETD/image/etd2065.pdf.

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Wang, Hui. "Response Adaptive Randomization using Surrogate and Primary Endpoints." VCU Scholars Compass, 2016. http://scholarscompass.vcu.edu/etd/4517.

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In recent years, adaptive designs in clinical trials have been attractive due to their efficiency and flexibility. Response adaptive randomization procedures in phase II or III clinical trials are proposed to appeal ethical concerns by skewing the probability of patient assignments based on the responses obtained thus far, so that more patients will be assigned to a superior treatment group. General response-adaptive randomizations usually assume that the primary endpoint can be obtained quickly after the treatment. However, in real clinical trials, the primary outcome is delayed, making it unusable for adaptation. Therefore, we utilize surrogate and primary endpoints simultaneously to adaptively assign subjects between treatment groups for clinical trials with continuous responses. We explore two types of primary endpoints commonly used in clinical tirials: normally distributed outcome and time-to-event outcome. We establish a connection between the surrogate and primary endpoints through a Bayesian model, and then update the allocation ratio based on the accumulated data. Through simulation studies, we find that our proposed response adaptive randomization is more effective in assigning patients to better treatments as compared with equal allocation randomization and standard response adaptive randomization which is solely based on the primary endpoint.
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Bennett, Maxine Sarah. "Improving the efficiency of clinical trial designs by using historical control data or adding a treatment arm to an ongoing trial." Thesis, University of Cambridge, 2018. https://www.repository.cam.ac.uk/handle/1810/271133.

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The most common type of confirmatory trial is a randomised trial comparing the experimental treatment of interest to a control treatment. Confirmatory trials are expensive and take a lot of time in the planning, set up and recruitment of patients. Efficient methodology in clinical trial design is critical to save both time and money and allow treatments to become available to patients quickly. Often there are data available on the control treatment from a previous trial. These historical data are often used to design new trials, forming the basis of sample size calculations, but are not used in the analysis of the new trial. Incorporating historical control data into the design and analysis could potentially lead to more efficient trials. When the historical and current control data agree, incorporating historical control data could reduce the number of control patients required in the current trial and therefore the duration of the trial, or increase the precision of parameter estimates. However, when the historical and current data are inconsistent, there is a potential for biased treatment effect estimates, inflated type I error and reduced power. We propose two novel weights to assess agreement between the current and historical control data: a probability weight based on tail area probabilities; and a weight based on the equivalence of the historical and current control data parameters. For binary outcome data, agreement is assessed using the posterior distributions of the response probability in the historical and current control data. For normally distributed outcome data, agreement is assessed using the marginal posterior distributions of the difference in means and the ratio of the variances of the current and historical control data. We consider an adaptive design with an interim analysis. At the interim, the agreement between the historical and current control data is assessed using the probability or equivalence probability weight approach. The allocation ratio is adapted to randomise fewer patients to control when there is agreement and revert back to a standard trial design when there is disagreement. The final analysis is Bayesian utilising the analysis approach of the power prior with a fixed weight. The operating characteristics of the proposed design are explored and we show how the equivalence bounds can be chosen at the design stage of the current study to control the maximum inflation in type I error. We then consider a design where a treatment arm is added to an ongoing clinical trial. For many disease areas, there are often treatments in different stages of the development process. We consider the design of a two-arm parallel group trial where it is planned to add a new treatment arm during the trial. This could potentially save money, patients, time and resources. The addition of a treatment arm creates a multiple comparison problem. Dunnett (1955) proposed a design that controls the family-wise error rate when comparing multiple experimental treatments to control and determined the optimal allocation ratio. We have calculated the correlation between test statistics for the method proposed by Dunnett when a treatment arm is added during the trial and only concurrent controls are used for each treatment comparison. We propose an adaptive design where the sample size of all treatment arms are increased to control the family-wise error rate. We explore adapting the allocation ratio once the new treatment arm is added to maximise the overall power of the trial.
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Riddell, Corinne Aileen. "An adaptive clinical trial design for a sensitive subgroup examined in the multiple sclerosis context." Thesis, University of British Columbia, 2011. http://hdl.handle.net/2429/33818.

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Adaptive clinical trials are recently gaining more attention. In this thesis, generalizations to the Biomarker-Adaptive Threshold Design (BATD) are studied and applied in the multiple sclerosis (MS) context. The BATD was originally developed for survival outcomes for Phase III clinical trials and allows researchers to both study the efficacy of treatment in the overall group and to investigate the relationship between a hypothesized predictive biomarker and the treatment effect on the primary outcome. We first introduce the original methodology and replicate the authors’ simulation studies to confirm their findings. Then, we generalize the methodology to accommodate count biomarkers and outcomes. Our interest in variables of this form is fuelled by the study of MS, where the number of relapses is a commonly used count outcome for patients with relapsing-remitting MS. Through simulation studies, we find that the BATD has increased power compared with a traditional fixed design under varying scenarios for which there exists a sensitive patient subgroup. As an illustrative example, we consider data from a previously completed trial and apply the methodology for two hypothesized markers: baseline lesion activity and the length of time that a patient has had MS. While we do not find a predictive biomarker relationship between baseline lesion activity and the number of relapses, MS duration does appear to have a predictive biomarker relationship for this dataset. In particular, we consider a randomly chosen subsample of the data for which the overall treatment effect on the outcome was insignificant. When the BATD is applied, a very significant treatment effect is detected and indicates that the effect is strongest for patients that have had MS for less than 7.8 years for this subsample. The methodology holds promise at preserving statistical power when the treatment effect is greatest in a sensitive patient subset.
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Shen, Andrea Ann. "Evaluation of Wave-Adaptive Modular Vessel Suspension Systems for Improved Dynamics." Thesis, Virginia Tech, 2013. http://hdl.handle.net/10919/23178.

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A study is conducted to test the dynamics of the 33ft Wave-Adaptive Modular Vessel (WAM-V) when outfitted with different suspension systems.  Instrumented with an array of sensors, the vessel is tested with two different suspension arrangements to characterize how they affect WAM-V dynamics, and to ultimately select a suspension that is most suitable for the 33ft WAM-V and other vessels that are planned for the future.
Optimizing the suspension can reduce the magnitude of accelerations at the payload tray, benefiting both the operator and the payload.  Reduced accelerations can significantly improve comfort and risk of injury to the operator, while also lessening the likelihood of any damage to any sensitive cargo onboard.  The stock suspension components are characterized through in-house tests conducted at the Center for Vehicle Systems and Safety (CVeSS) at Virginia Tech (VT).  Based on the stock characterizations, new suspension components are chosen to better fit the needs of the 33ft WAM-V.
Sea trials are conducted with both suspension systems at the Combatant Craft Division (CCD), a division of the Naval Surface Warfare Center, Carderock Division (NSWCCD), in Norfolk, VA to quantitatively and qualitatively determine the differences between the two suspensions.  The 33ft WAM-V is instrumented with a series of accelerometers and potentiometers for measuring accelerations and displacements.  The data is analyzed for the sea trials conducted at CCD and the results of the analysis indicate that the suspension selection can significantly affect the transmission of shock and vibrations from the pontoons to the operator or payload tray.  Both suspensions are able to mitigate a significant amount of the shocks seen at the pontoons, however, the results do not definitively show which suspension is the better of the two.  This is due to the fact that each suspension is not subjected to the exact same wave conditions, and  
therefore the resulting suspension dynamics vary.  For instance, during a 2-foot wave event, the new suspension attenuates more shock than the stock suspension, 76% versus 71%.  However, during a 4-foot wave event, the stock suspension attenuates more shock than the new suspension, 66% versus 60%.
Additionally, the suspension selection can significantly influence the ride height.  The stock suspension provides a 70/30 ratio between extension and compression stroke, while the new suspension provides a 50/50 ratio.  The more balanced split between the extension and compression strokes allow for better utilizing the total available stroke for the suspension in both directions.  This significantly reduces the resulting high-g impacts since the suspension does not frequently bottom out when the vessel is subjected to a large wave.
It is recommended that the results of this study be extended through laboratory dynamic testing that allows for more repeatable dynamic events than sea trials in order to better establish the influence of each suspension parameter on the vessel dynamics.  Such tests will also allow for a better understanding of the dynamics of the vessel in response to various inputs at the pontoons, both subjectively (visually) and objectively (through measurements).
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Books on the topic "Adaptive trial"

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He, Weili, José Pinheiro, and Olga M. Kuznetsova, eds. Practical Considerations for Adaptive Trial Design and Implementation. New York, NY: Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1100-4.

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Clinical trial design: Bayesian and frequentist adaptive methods. Hoboken, N.J: John Wiley & Sons, 2012.

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Classical and adaptive clinical trial designs with ExpDesign Studio? Hoboken, N.J: John Wiley, 2008.

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Chang, Mark. Introductory adaptive trial designs: A practical guide with R. Boca Raton, Fla: CRC Press, 2015.

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Ondra, Thomas. Optimized Response-Adaptive Clinical Trials. Wiesbaden: Springer Fachmedien Wiesbaden, 2015. http://dx.doi.org/10.1007/978-3-658-08344-1.

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Adaptive and flexible clinical trials. Boca Raton: CRC Press, 2012.

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Manuel, Ulrich. Consultancy reports on various socio-economic aspects concerning the adaptive on-farm trial programme of the collaborative AGRITEX-GTZ project, Conservation Tillage for Sustainable Crop Production Systems. Borrowdale, Harare: Deutsche Gesellschaft für Technische Zusammenarbeit GmbH, 1994.

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Mark, Chang, ed. Adaptive design methods in clinical trials. 2nd ed. Boca Raton: Taylor & Francis, 2012.

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Bayesian adaptive methods for clinical trials. Boca Raton: Chapman & Hall/CRC, 2011.

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Association, Dude Ranchers'. Horse Safety & Adaptive First Aid for the Trail. USA]: The Association, 2005.

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Book chapters on the topic "Adaptive trial"

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Pinheiro, José C., Frank Bretz, and Chyi-Hung Hsu. "Adaptive Trial Designs." In Clinical Trial Simulations, 109–30. New York, NY: Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-7415-0_6.

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Richman, Joshua S., and Judy C. Boughey. "Adaptive Trial Designs." In Clinical Trials Design in Operative and Non Operative Invasive Procedures, 99–107. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-53877-8_11.

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Chang, Mark. "Adaptive Trial Design." In Modern Issues and Methods in Biostatistics, 87–115. New York, NY: Springer New York, 2011. http://dx.doi.org/10.1007/978-1-4419-9842-2_4.

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Chow, Shein-Chung, and Fuyu Song. "Adaptive Clinical Trial Design." In Quantitative Methods for HIV/AIDS Research, 41–62. Boca Raton : Taylor & Francis, 2017. | “A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc.”: Chapman and Hall/CRC, 2017. http://dx.doi.org/10.1201/9781315120805-4.

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Chang, Mark, John Balser, Jim Roach, and Robin Bliss. "Globally Optimal Adaptive Trial Designs." In Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, 85–116. Boca Raton : Taylor & Francis, 2019.: Chapman and Hall/CRC, 2019. http://dx.doi.org/10.1201/9781351214544-4.

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Pong, Annpey, and Shein-Chung Chow. "Adaptive Trial Design in Clinical Research." In Biopharmaceutical Applied Statistics Symposium, 75–99. Singapore: Springer Singapore, 2018. http://dx.doi.org/10.1007/978-981-10-7829-3_3.

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Chow, Shein-Chung. "Two-Stage Adaptive Seamless Trial Design." In Innovative Methods for Rare Disease Drug Development, 205–26. Boca Raton, FL : CRC Press, 2021. |: Chapman and Hall/CRC, 2020. http://dx.doi.org/10.1201/9781003049364-11.

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Carline, Anna, Clare Gunby, and Jamie Murray. "Conclusion: Techniques of Affect and Adaptive Management." In Rape and the Criminal Trial, 129–42. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-38684-9_7.

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Ampt, Peter, Alex Baumber, and Katrina Gepp. "Adaptive Management of a Sustainable Wildlife Enterprise Trial in Australia's Barrier Ranges." In Adaptive Environmental Management, 73–94. Dordrecht: Springer Netherlands, 2009. http://dx.doi.org/10.1007/978-1-4020-9632-7_5.

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Perevozskaya, Inna, Lixin Han, and Kristen Pierce. "Continual Reassessment Method for a First-in-Human Trial: From Design to Trial Implementation." In Practical Considerations for Adaptive Trial Design and Implementation, 357–81. New York, NY: Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1100-4_19.

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Conference papers on the topic "Adaptive trial"

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Lu, Xiaofeng. "Adaptive Design Practice in Clinical Trial." In 2020 International Conference on Public Health and Data Science (ICPHDS). IEEE, 2020. http://dx.doi.org/10.1109/icphds51617.2020.00084.

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Senger, Christian, Vladimir R. Sidorenko, Steffen Schober, Martin Bossert, and Victor V. Zyablov. "Adaptive single-trial error/erasure decoding of binary codes." In Its Applications (Isita2010). IEEE, 2010. http://dx.doi.org/10.1109/isita.2010.5648959.

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Heffner, B., T. Schmidt, R. Saunders, R. Hui, D. Richards, and G. Nicholl. "43Gb/s Adaptive Polarization Mode Dispersion Compensator Field Trial." In OFC/NFOEC 2007 - 2007 Conference on Optical Fiber Communication and the National Fiber Optic Engineers Conference. IEEE, 2007. http://dx.doi.org/10.1109/ofc.2007.4348514.

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Senger, Christian, Vladimir R. Sidorenko, Steffen Schober, Martin Bossert, and Victor V. Zyablov. "Adaptive single-trial error/erasure decoding of Reed-Solomon codes." In 2011 12th Canadian Workshop on Information Theory (CWIT). IEEE, 2011. http://dx.doi.org/10.1109/cwit.2011.5872121.

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Liu, Qingjuan, and Jialin Cao. "Empty adaptive trial study on airport prestressed concrete road surface." In 2018 7th International Conference on Energy and Environmental Protection (ICEEP 2018). Paris, France: Atlantis Press, 2018. http://dx.doi.org/10.2991/iceep-18.2018.133.

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Calfee, C. S., M. Eklund, T. E. Albertson, S. Auld, J. R. Beitler, P. A. Berger, E. L. Burnham, et al. "The I-SPY COVID Trial: First Results from an Adaptive Platform Phase 2 Trial for Severe COVID-19." In American Thoracic Society 2022 International Conference, May 13-18, 2022 - San Francisco, CA. American Thoracic Society, 2022. http://dx.doi.org/10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a5284.

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Boudiaf, Mahmoud, Moncef Benkherrat, and Khaled Mansouri. "Comparison of adaptive algorithms for single-trial event-related potentials extraction." In 2017 Intelligent Systems Conference (IntelliSys). IEEE, 2017. http://dx.doi.org/10.1109/intellisys.2017.8324275.

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Chin-Teng Lin, Yu-Kai Wang, Chieh-Ning Fang, Yi-Hsin Yu, and Jung-Tai King. "Extracting patterns of single-trial EEG using an adaptive learning algorithm." In 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2015. http://dx.doi.org/10.1109/embc.2015.7319916.

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Sun, Zhe, Xiaodong Kang, Xiaoxu Tang, Xingcai Wu, Qiang Li, Yu Wang, Tianhui Wang, and Hong Zhang. "Performance Evaluation and Field Trial of Self-Adaptive Microgel Flooding Technology." In Abu Dhabi International Petroleum Exhibition & Conference. Society of Petroleum Engineers, 2018. http://dx.doi.org/10.2118/192651-ms.

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Mirgholami, Mahsa, Soroosh Shahtalebi, William Cui, Raika Karimi, Amir Asif, and Arash Mohammadi. "Adaptive Subject-Specific Bayesian Spectral Filtering for Single Trial Eeg Classification." In 2019 IEEE Global Conference on Signal and Information Processing (GlobalSIP). IEEE, 2019. http://dx.doi.org/10.1109/globalsip45357.2019.8969391.

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Reports on the topic "Adaptive trial"

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Zhang, Cheng, and Yue Yang. Impact of adaptive design on reducing the duration of clinical trials in rare cancers: a meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, February 2022. http://dx.doi.org/10.37766/inplasy2022.2.0081.

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Review question / Objective: Whether the application of adaptive design in clinical trials of rare cancers can shorten the duration of clinical trials? Condition being studied: Currently, the development of innovative drug products (InMPs) for rare cancers faces many challenges, including the difficulty of enrolling sufficient numbers of patients from small and heterogeneous patient populations for clinical trials, and the significant risks of high financial investment, long development times and potential failure from a pharmaceutical company's perspective for rare cancer drugs due to limited knowledge of the natural history of the disease. Therefore, alternative approaches to clinical trial design are needed to conduct cost-effective, well-controlled analyses that can assess treatment effects in small, heterogeneous populations within shorter time frames. Adaptive trials, on the other hand, may be an effective solution to this problem. Adaptive clinical trials are designed to accelerate the clinical trial process by making predefined adjustments to key parameters through data accumulated at predefined time points during the trial without compromising the integrity and validity of the results.This study aims to examine the value of adaptive design in reducing the duration of clinical trials in rare cancers and encourage their wider implementation.
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Mahncke, Henry W. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, October 2013. http://dx.doi.org/10.21236/ada610839.

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Mahncke, Henry W. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, October 2015. http://dx.doi.org/10.21236/ada636865.

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Mahncke, Henry W. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, October 2012. http://dx.doi.org/10.21236/ada569022.

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Chaudhuri, Shomesh, Andrew Lo, Danying Xiao, and Qingyang Xu. Bayesian Adaptive Clinical Trials for Anti‐Infective Therapeutics during Epidemic Outbreaks. Cambridge, MA: National Bureau of Economic Research, May 2020. http://dx.doi.org/10.3386/w27175.

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Rosenblum, Michael, Jon Arni Steingrimsson, and Josh Betz. New Methods and Software for Designing Adaptive Clinical Trials of New Medical Treatments. Patient-Centered Outcomes Research Institute® (PCORI), October 2019. http://dx.doi.org/10.25302/10.2019.me.130603198.

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Wayant, Nicole. Adapting agile philosophies and tools for a research environment. Engineer Research and Development Center (U.S.), September 2022. http://dx.doi.org/10.21079/11681/45442.

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There exist myriad project management methodologies, but none is focused solely on scientific research. Research projects are unique compared to other types of projects, including software development, manufacturing, and drug trials; research projects inherently have unplanned risks. These risks provide a challenge to managing resources, developing schedules, and providing team ownership while still achieving project goals. To help mitigate the risks and the challenges associated with scientific research, a methodology to manage research projects needs to be developed.
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Choudhary, Ruplal, Victor Rodov, Punit Kohli, Elena Poverenov, John Haddock, and Moshe Shemesh. Antimicrobial functionalized nanoparticles for enhancing food safety and quality. United States Department of Agriculture, January 2013. http://dx.doi.org/10.32747/2013.7598156.bard.

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Original objectives The general goal of the project was to utilize the bactericidal potential of curcumin- functionalizednanostructures (CFN) for reinforcement of food safety by developing active antimicrobial food-contact surfaces. In order to reach the goal, the following secondary tasks were pursued: (a) further enhancement of the CFN activity based on understanding their mode of action; (b) preparing efficient antimicrobial surfaces, investigating and optimizing their performance; (c) testing the efficacy of the antimicrobial surfaces in real food trials. Background to the topic The project dealt with reducing microbial food spoilage and safety hazards. Cross-contamination through food-contact surfaces is one of the major safety concerns, aggravated by bacterial biofilm formation. The project implemented nanotech methods to develop novel antimicrobial food-contact materials based on natural compounds. Food-grade phenylpropanoidcurcumin was chosen as the most promising active principle for this research. Major conclusions, solutions, achievements In agreement with the original plan, the following research tasks were performed. Optimization of particles structure and composition. Three types of curcumin-functionalizednanostructures were developed and tested: liposome-type polydiacetylenenanovesicles, surface- stabilized nanoparticles and methyl-β-cyclodextrin inclusion complexes (MBCD). The three types had similar minimal inhibitory concentration but different mode of action. Nanovesicles and inclusion complexes were bactericidal while the nanoparticlesbacteriostatic. The difference might be due to different paths of curcumin penetration into bacterial cell. Enhancing the antimicrobial efficacy of CFN by photosensitization. Light exposure strengthened the bactericidal efficacy of curcumin-MBCD inclusion complexes approximately three-fold and enhanced the bacterial death on curcumin-coated plastic surfaces. Investigating the mode of action of CFN. Toxicoproteomic study revealed oxidative stress in curcumin-treated cells of E. coli. In the dark, this effect was alleviated by cellular adaptive responses. Under light, the enhanced ROS burst overrode the cellular adaptive mechanisms, disrupted the iron metabolism and synthesis of Fe-S clusters, eventually leading to cell death. Developing industrially-feasible methods of binding CFN to food-contact surfaces. CFN binding methods were developed for various substrates: covalent binding (binding nanovesicles to glass, plastic and metal), sonochemical impregnation (binding nanoparticles to plastics) and electrostatic layer-by-layer coating (binding inclusion complexes to glass and plastics). Investigating the performance of CFN-coated surfaces. Flexible and rigid plastic materials and glass coated with CFN demonstrated bactericidal activity towards Gram-negative (E. coli) and Gram-positive (Bac. cereus) bacteria. In addition, CFN-impregnated plastic material inhibited bacterial attachment and biofilm development. Testing the efficacy of CFN in food preservation trials. Efficient cold pasteurization of tender coconut water inoculated with E. coli and Listeriamonocytogeneswas performed by circulation through a column filled with CFN-coated glass beads. Combination of curcumin coating with blue light prevented bacterial cross contamination of fresh-cut melons through plastic surfaces contaminated with E. coli or Bac. licheniformis. Furthermore, coating of strawberries with CFN reduced fruit spoilage during simulated transportation extending the shelf life by 2-3 days. Implications, both scientific and agricultural BARD Report - Project4680 Page 2 of 17 Antimicrobial food-contact nanomaterials based on natural active principles will preserve food quality and ensure safety. Understanding mode of antimicrobial action of curcumin will allow enhancing its dark efficacy, e.g. by targeting the microbial cellular adaptation mechanisms.
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Chiel, Elad, and Christopher J. Geden. Development of sustainable fly management tools in an era of global warming. United States Department of Agriculture, January 2014. http://dx.doi.org/10.32747/2014.7598161.bard.

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House flies (Muscadomestica) are global pests of animal agriculture, causing major annoyance, carrying pathogens among production facilities and humans and thus have profound impacts on animal comfort and productivity. Successful fly control requires an integrated pest management (IPM) approach that includes elements of manure management, mass trapping, biological control, and selective insecticide use. Insecticidal control of house flies has become increasingly difficult due to the rapidity with which resistance develops, even to new active ingredients. Global climate change poses additional challenges, as the efficacy of natural enemies is uncertain under the higher temperatures that are predicted to become more commonplace in the future. The two major objectives of this research project were: 1) to develop a cost-effective autodissemination application method of Pyriproxifen (PPF), an insect growth regulator, for controlling house flies; 2) to study the effect of increasing temperatures on the interactions between house flies and their principal natural enemies. First, we collected several wild house fly populations in both countries and established that most of them are susceptible to PPF, although one population in each country showed initial signs of PPF-resistance. An important finding is that the efficacy of PPF is substantially reduced when applied in cows’ manure. We also found that PPF is compatible with several common species of parasitoids that attack the house fly, thus PPF can be used in IPM programs. Next, we tried to develop “baited stations” in which house flies will collect PPF on their bodies and then deliver and deposit it in their oviposition sites (= autodissemination). The concept showed potential in lab experiments and in outdoor cages trials, but under field conditions the station models we tested were not effective enough. We thus tested a somewhat different approach – to actively release a small proportion of PPF-treated flies. This approach showed positive results in laboratory experiments and awaits further field experiments. On the second topic, we performed two experimental sets: 1) we collected house flies and their parasitoids from hot temperature and mild temperature areas in both countries and, by measuring some fitness parameters we tested whether the ones collected from hot areas are better adapted to BARD Report - Project 4701 Page 2 of 16 heat. The results showed very little differences between the populations, both of flies and parasitoids. 2) A “fast evolution” experiment, in which we reared house flies for 20 generations under increasing temperatures. Also here, we found no evidence for heat adaptation. In summary, pyriproxyfen proved to be a highly effective insect growth regulator for house flies that is compatible with it’s natural enemies. Although our autodissemination stations yielded disappointing results, we documented the proportion of flies in a population that must be exposed to PPF to achieve effective fly control. Both the flies and their principal parasitoids show no evidence for local adaptation to high temperatures. This is an encouraging finding for biological control, as our hypothesis was that the fly would be adapting faster to high temperatures than the parasitoids. BARD Report - Project 4701 Page 3 of 16
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Determining the “IMPACT” of therapeutics for depression requires an adaptive trial design. ACAMH, August 2018. http://dx.doi.org/10.13056/acamh.10573.

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A large proportion of adolescents suffering from moderate-to-severe major depression respond to psychological and pharmacological therapy, and the range of effective treatment modalities is increasing. Now, Ian Goodyer and Paul Wilkinson have compiled a Practitioner Review that compares the various treatment options available and assesses their effectiveness for adolescents affected by major depressive episodes.
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