Academic literature on the topic 'Rule based oncology designs'

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Journal articles on the topic "Rule based oncology designs"

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Ji, Yuan, and Meizi Liu. "The i3+3 design for phase I clinical trials." Journal of Clinical Oncology 37, no. 15_suppl (2019): 3066. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.3066.

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3066 Background: Other than the 3+3 design, new model-based statistical designs like the mTPI design (Ji and Wang, 2013, JCO) are alternative choices for oncology dose-finding trials, including immune oncology dose-finding trials (Atkins et al., 2018, Lancet Oncology). One major criticism of the 3+3 design is that it is based on simple rules, does not depend on statistical models for inference, and leads to unsafe and unreliable operating characteristics. However, the rule-based nature allows 3+3 to be easily understood and implemented in practice, making it practically attractive and friendly. Can friendly rule-based designs achieve great performance seen in model-based designs? For four decades, the answer has been NO. Methods: We propose a new rule-based design called i3+3, where the letter "i" represents the word "interval". The i3+3 design is based on simple but more clever rules that account for the variabilities in the observed data. In short, the i3+3 design simply asks clinicians to compare observed toxicity rates with a prespecified toxicity interval, and make dose escalation decisions according to three simple rules. No sophisticated modeling is needed and the entire design is transparent to clinicians. Results: We compare the operating characteristics for the proposed i3+3 design with other popular phase I designs by simulation. The i3+3 design is far superior than the 3+3 design in trial safety and the ability to identify the true MTD. Compared with model-based phase I designs, i3+3 also demonstrates comparable performances. In other words, the i3+3 design possesses both simplicity and transparency of the rule-based approaches, and the superior operating characteristics seen in model-based approaches. An online R Shiny tool is provided to illustrate the i3+3 design, although in practice it requires no software to design or conduct a dose-finding trial using the design. Conclusions: The i3+3 design could be a practice-altering method for the clinical community. It may increase the safety and efficiency of dose finding trials.
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Shimomura, A., T. Ebata, T. Koyama, et al. "Comparison of model-based dose escalation design with rule-based design of phase I oncology trials." Annals of Oncology 29 (March 2018): iii26—iii27. http://dx.doi.org/10.1093/annonc/mdy047.067.

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Lin, Ruitao, Yanhong Zhou, Fangrong Yan, Daniel Li, and Ying Yuan. "BOIN12: Bayesian Optimal Interval Phase I/II Trial Design for Utility-Based Dose Finding in Immunotherapy and Targeted Therapies." JCO Precision Oncology, no. 4 (November 2020): 1393–402. http://dx.doi.org/10.1200/po.20.00257.

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PURPOSE For immunotherapy, such as checkpoint inhibitors and chimeric antigen receptor T-cell therapy, where the efficacy does not necessarily increase with the dose, the maximum tolerated dose may not be the optimal dose for treating patients. For these novel therapies, the objective of dose-finding trials is to identify the optimal biologic dose (OBD) that optimizes patients’ risk-benefit trade-off. METHODS We propose a simple and flexible Bayesian optimal interval phase I/II (BOIN12) trial design to find the OBD that optimizes the risk-benefit trade-off. The BOIN12 design makes the decision of dose escalation and de-escalation by simultaneously taking account of efficacy and toxicity and adaptively allocates patients to the dose that optimizes the toxicity-efficacy trade-off. We performed simulation studies to evaluate the performance of the BOIN12 design. RESULTS Compared with existing phase I/II dose-finding designs, the BOIN12 design is simpler to implement, has higher accuracy to identify the OBD, and allocates more patients to the OBD. One of the most appealing features of the BOIN12 design is that its adaptation rule can be pretabulated and included in the protocol. During the trial conduct, clinicians can simply look up the decision table to allocate patients to a dose without complicated computation. CONCLUSION The BOIN12 design is simple to implement and yields desirable operating characteristics. It overcomes the computational and implementation complexity that plagues existing Bayesian phase I/II dose-finding designs and provides a useful design to optimize the dose of immunotherapy and targeted therapy. User-friendly software is freely available to facilitate the application of the BOIN12 design.
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Fried, Jessica G., Michael Joseph Lariviere, Ravi Bharat Parikh, et al. "Design and implementation of outpatient-based rapid MRI protocols to rule out metastatic spinal cord compression and brain metastases." Journal of Clinical Oncology 37, no. 15_suppl (2019): e18307-e18307. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e18307.

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e18307 Background: Metastatic spinal cord compression (MSCC) and symptomatic brain metastases (mets) are potential emergencies that demand coordinated multidisciplinary management. Patients (pts) with concerning symptoms are often referred to the Emergency Department (ED) for expedited imaging, but most do not require subsequent ED or inpatient management. Unnecessary ED visits incur substantial cost to the health system and patients, and cause psychosocial stress for patients often near the end-of-life. To improve access to expedited outpatient imaging for high-risk pts and reduce unnecessary ED visits, we developed outpatient rapid MRI protocols and pathways to rule out MSCC and brain mets. Methods: Tailored abbreviated MRI protocols were developed to allow rapid acquisition of brain ( < 13 minutes) and full spine ( < 25 minutes) exams. Dedicated appointments were reserved on the daily MRI schedule. Exams were immediately interpreted and reported by Radiology to the ordering clinician. This pathway was piloted within the Thoracic Oncology group beginning in 10/2018. Results: Referring specialties included Radiation Oncology (50%), Medical Oncology (36%), Pulmonology (7%), and Surgery (7%). For 6 pts who had outpatient rapid brain imaging, median time from order to exam start was 4.3 h (1.8-31) and order to final report 6.8 h (3.2-34.1). Brain mets were found in 4/6 patients. Only 1/4 positive studies required subsequent ED management. For 8 pts referred for rapid spine imaging, median time from order to exam start was 14.4 h (2.2-72.5) and order to final report 16.7 h (4.0-74.4). Only 1 patient was found to have cord compression and required ED/inpatient management. Overall, 86% of patients did not require ED or inpatient admission. 3 pts (all with negative imaging) died a median 13.4 d (1.4-28.3) after order placement. Conclusions: Outpatient rapid MRI protocols facilitate same-day imaging, interpretation, and management, improving care for thoracic oncology pts with new concerning neurologic symptoms and reducing unnecessary ED visits. Future work will expand access beyond Thoracic Oncology and further quantify improvements in cost savings and patient quality of life.
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Skolnik, J., B. Jayaraman, D. Patel, E. O'Connor, J. S. Barrett, and P. C. Adamson. "A clinical trial simulation study of a new pediatric phase I trial methodology: The rolling six design." Journal of Clinical Oncology 25, no. 18_suppl (2007): 9564. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.9564.

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9564 Background: Phase I cancer trials have traditionally used the 3+3 study design in which cohorts of three patients at a time are enrolled. The study is suspended to accrual with every 3rd patient, and again suspended to replace inevaluable patients. As the pediatric phase I starting dose is based on adult phase I safety data, we hypothesized that pediatric study timelines could be shortened without increasing risk using a novel rolling six design, in which up to 6 patients are concurrently enrolled per dose level. Methods: A trial simulation approach comparing the standard 3+3 design to the rolling six design was performed. Discrete time events (accrual/enrollment, evaluation and/or time to dose limiting toxicity (DLT) or inevaluability) with outcome probabilities (DLT/inevaluability) assigned to each subject based on historical data from phase I pediatric oncology trials. The probability of DLT was a function of dose level and varied distributions were used to assign discrete time elements. Metrics for study efficiency (time to complete study, total number of patients required) were determined for each design. Simulated trials and decision rule logic were coded using PC/Windows SAS v9.1. Results: The rolling six design outperformed the 3+3 design for the most relevant metrics. Average (±SD) time to study completion was 373±90 days vs. 431±98 days and the total number of patients required was 20±5 vs. 17±4 for the rolling six vs. 3+3 designs, respectively. There was no difference in the number of DLTs per study (3±1) between designs. Conclusions: The rolling six design is predicted to shorten pediatric phase 1 study timelines and will be tested prospectively in upcoming COG phase I trials. No significant financial relationships to disclose.
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Melloni, Giorgio E. M., Alessandro Guida, Giuseppe Curigliano, et al. "Precision Trial Drawer, a Computational Tool to Assist Planning of Genomics-Driven Trials in Oncology." JCO Precision Oncology, no. 2 (November 2018): 1–16. http://dx.doi.org/10.1200/po.18.00015.

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Purpose Trials that accrue participants on the basis of genetic biomarkers are a powerful means of testing targeted drugs, but they are often complicated by the rarity of the biomarker-positive population. Umbrella trials circumvent this by testing multiple hypotheses to maximize accrual. However, bigger trials have higher chances of conflicting treatment allocations because of the coexistence of multiple actionable alterations; allocation strategies greatly affect the efficiency of enrollment and should be carefully planned on the basis of relative mutation frequencies, leveraging information from large sequencing projects. Methods We developed software named Precision Trial Drawer (PTD) to estimate parameters that are useful for designing precision trials, most importantly, the number of patients needed to molecularly screen (NNMS) and the allocation rule that maximizes patient accrual on the basis of mutation frequency, systematically assigning patients with conflicting allocations to the drug associated with the rarer mutation. We used data from The Cancer Genome Atlas to show their potential in a 10-arm imaginary trial of multiple cancers on the basis of genetic alterations suggested by the past Molecular Analysis for Personalised Therapy (MAP) conference. We validated PTD predictions versus real data from the SHIVA (A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer) trial. Results In the MAP imaginary trial, PTD-optimized allocation reduces number of patients needed to molecularly screen by up to 71.8% (3.5 times) compared with nonoptimal trial designs. In the SHIVA trial, PTD correctly predicted the fraction of patients with actionable alterations (33.51% [95% CI, 29.4% to 37.6%] in imaginary v 32.92% [95% CI, 28.2% to 37.6%] expected) and allocation to specific treatment groups (RAS/MEK, PI3K/mTOR, or both). Conclusion PTD correctly predicts crucial parameters for the design of multiarm genetic biomarker-driven trials. PTD is available as a package in the R programming language and as an open-access Web-based app. It represents a useful resource for the community of precision oncology trialists. The Web-based app is available at https://gmelloni.github.io/ptd/shinyapp.html .
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Ji, Yuan. "The joint i3+3 (Ji3+3) design for phase I / II adoptive cell therapy clinical trials." Journal of Clinical Oncology 38, no. 15_suppl (2020): e14083-e14083. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e14083.

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e14083 Background: Adoptive cell therapy (ACT), such as chimeric antigen receptor (CAR) T-cell therapy, have demonstrated promising therapeutic effects. However, it has been shown by previous studies that dose-response of ACTs may be complex and non-monotonic. For example, a ten-fold increase in dose level may not necessarily lead to higher anti-cancer response. This creates a new challenge for dose-finding trials with ACTs since higher dose may not lead to higher probability of efficacy. Methods: We propose a novel statistical design called the joint i3+3 design (Ji3+3) which extends our previous work of the i3+3 design (ASCO 2019 abstract 268979) and addresses the dose-finding challenge for ACT trials. In particular, Ji3+3 is a rule-based method that can be easily understood, visualized, and implemented by clinicians. It uses a set of smart rules based on observed efficacy and toxicity outcomes, and conducts up-and-down dose escalation decisions based on dose-response intervals. The entire dose-finding algorithm and decision rules can be presented as a precalculated table, which can be examined, discussed, modified, and approved as part of trial design. Results: Motivated by a CAR T trial (NCT03971799) we demonstrate the superiority of the Ji3+3 design through extensive computer simulations. Compared with the 3+3 design and i3+3 design, we show that Ji3+3 has a much higher chance finding the BOD and allocates more patients to desirable doses. The impact of these results will be to help investigators and drug developers identify a dose that is efficacious and safe, thereby increasing the probability of success to market the ACT and improving patient care. Conclusions: The Ji3+3 design is a novel, simple, and effective method that can potentially significantly improve the dose finding for ACT clinical trials.
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Hernando-Calvo, Alberto, Abdulazeez Salawu, Marc Oliva Bernal, et al. "A risk stratification model for toxicities in phase 1 immuno-oncology (P1-IO) trials." Journal of Clinical Oncology 39, no. 15_suppl (2021): 2648. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.2648.

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2648 Background: Despite an exponential increase in the number of potential targets in the immuno-oncology (IO) field, lack of risk models to predict toxicities remains a challenge in early drug development. We proposed a risk stratification strategy and investigated whether different IO classes may be associated with incremental risk of toxicities. Methods: A systematic search for IO studies from 01/2014 to 10/2020 was conducted. Among the 12053 abstracts screened, 254 reporting phase I-IO trials were selected. Type of IO treatment (IO monotherapy [mono] vs IO combination [comb]), therapeutic class (e.g. IO, molecularly targeted agents [MTA]), and dose escalation method (rule-based, model-based and model-assisted) were collected. A risk scoring model was developed after expert consensus: treatment-related deaths (1:yes, 0:no), incidence of G3/G4 treatment related adverse events (TRAE) or treatment emergent adverse events (TEAE) (0 if 1-29%,1 if ≥30-49%, 2 if ≥50%), incidence of ≥G2 cytokine release syndrome (1:yes, 0:no), incidence of ≥G2 encephalopathy (1:yes 0:no) and incidence of dose-limiting toxicity (DLT) (0:no, 1:lab, 2:clinical). Risk categories were defined by summing all points (0 = low, 1-2 = intermediate, 3+ = high) and were correlated with type of IO treatment, therapeutic class and dose escalation method. Results: Of 254 P1-IO trials reviewed, 228 (90%) were scorable, 26 were not (25 due to lack of AE data). Up to 10/26 (38%) of non-scorable studies were cell therapies. Among the 228 scorable studies, 120 (53%) scored 0, 65 (28%) scored 1-2, 43 (19%) scored 3+; 24 (11%) and 125 (55%) did not provide no. of pts with G3/G4 TRAEs or TEAEs respectively. A significant association was observed between risk categories and therapeutic class (p<0.001) (see table). Additionally, IO-MTA and IO-IO were both associated with an increased risk of toxicity as compared to IO-mono (OR=3.91 (95%CI 1.7-9.2), p=0.002) and (OR=2.79 (95%CI 1.2-6.5), p=0.02) respectively. There was no association between dose escalation method and risk of toxicity (p=0.95), but 182 (92%) used rule-based methods. Conclusions: Our results suggest that different IO classes are associated with different risks of toxicity. This risk classification strategy may guide future clinical trial design. Additionally, standards for reporting toxicities in P1-IO trials are urgently needed.[Table: see text]
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Pizzichetta, Maria Antonietta, Renato Talamini, Domenico Piccolo, et al. "Interobserver Agreement of the Dermoscopic Diagnosis of 129 Small Melanocytic Skin Lesions." Tumori Journal 88, no. 3 (2002): 234–38. http://dx.doi.org/10.1177/030089160208800309.

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Aim and background Dermoscopic diagnosis of pigmented skin lesions is based on the evaluation of dermoscopic criteria (classical pattern analysis) and on alternative diagnostic methods, such as the ABCD (A, asymmetry; B, border; C, color; D, differential structures) rule based on the total dermatoscopic score. The aim of the study was to investigate the interobserver agreement of standard dermoscopic criteria between two observers and the diagnostic validity of dermoscopic diagnosis by pattern analysis and by the ABCD rule. Study design The study included a total of 129 small (≤5 mm) melanocytic skin lesions selected from all lesions observed in consecutive patients between April 1996 and September 1998. Before surgery, each lesion was photographed with a Dermaphot. Dermoscopic images were examined independently by two observers to evaluate the presence or absence of standard dermoscopic criteria and to establish the dermoscopic diagnosis by pattern analysis and by the ABCD rule. Results Interobserver agreement for dermoscopic criteria varied from moderately good to good, with the highest agreement for radial streaks (k = 0.96) and the lowest for pseudopods (k = 0.49). Interobserver agreement was moderately good in dermoscopic diagnosis by pattern analysis (k = 0.48) and by the total dermatoscopic score (k = 0.44). The sensitivity and specificity of dermoscopic diagnosis by pattern analysis were 40% and 99%, respectively, for both observers. As regards the total dermatoscopic score (a cutoff score of ≤5.45 vs >5.45), sensitivity ranged from 80% to 100% and specificity from 48% to 59%. Conclusions The study showed that the pattern analyses as well as the ABCD rule give a poor discrimination between benign and malignant lesions and do not add relevant information for management decision in small melanocytic lesions. However, close follow-up examinations of small equivocal melanocytic lesions using digital equipment allow evaluation of their dermoscopic features during progression and whether their rather commonly found atypical dermoscopic features are lost during their natural course of growth.
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Frank, Xavier. "Is Watson for Oncology per se Unreasonably Dangerous?: Making A Case for How to Prove Products Liability Based on a Flawed Artificial Intelligence Design." American Journal of Law & Medicine 45, no. 2-3 (2019): 273–94. http://dx.doi.org/10.1177/0098858819871109.

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Artificial intelligence (AI) machines hold the world's curiosity captive. Futuristic television shows like West World are set in desert lands against pink sunsets where sleek, autonomous AI fulfill every human need, desire, and kink. But I, Robot, a movie where robots turn against the humans they serve, reminds us that AI is precarious. Academicians who study how AI interacts with tort law, such as Jessica Allain, David Vladeck, and Sjur Dyrkoltbotn, claim that the current legal regime is incapable of addressing the liability issues AI present. Both Allain and Vladeck focus their research on whether tort law can accommodate claims against fully autonomous AI machines, while Dyrkoltbotn explores how AI can be leveraged to help plaintiffs identify the genesis of their injuries. The solution this article presents is not exclusively tailored to fully autonomous AI and does not identify how technology can be used in tort claims. It instead demonstrates that the current tort law regime can provide relief to plaintiffs who are injured by AI machines. In particular, this article argues that the manner in which Watson for Oncology is designed presents a new context in which courts should adopt a per se rule of liability that favors plaintiffs who bring damage claims against AI machines by expanding the definition of what it means for a device to be unreasonably dangerous.
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Dissertations / Theses on the topic "Rule based oncology designs"

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Stark, Amy S. Ruppert. "Early Clinical Trial Design Recommendations in Oncology Based on Overall Success across Phases I, II, and III." The Ohio State University, 2017. http://rave.ohiolink.edu/etdc/view?acc_num=osu1510592650256558.

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Bayar, Mohamed Amine. "Randomized Clinical Trials in Oncology with Rare Diseases or Rare Biomarker-based Subtypes." Thesis, Université Paris-Saclay (ComUE), 2019. http://www.theses.fr/2019SACLS441.

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Le design standard des essais randomisés de phase III suppose le recrutement d'un grand nombre de patients pour assurer un risque α de 0.025 unilatéral et une puissance d'au moins 80%. Ceci s'avérer difficile dans les maladies rares, ou encore si le traitement cible une population spécifique définie par un sous-type moléculaire rare. Nous avons évalué par simulation la performance d'une série d'essais randomisés. Au terme de chaque essai, s'il est associé à une amélioration significative, le traitement expérimental devient le contrôle de l'essai suivant. Les designs ont été évalués pour différents taux de recrutement, différentes sévérités de la maladie, et différentes distributions hypothétiques des effets d'un futur traitement. Nous avons montré, que sous des hypothèses raisonnables, une série d'essais de plus petite taille et avec un risque α relâché est associée à un plus grand bénéfice à long terme que deux essais de design standard. Nous avons enrichi cette approche avec des designs plus flexibles incluant des analyses intermédiaires d'efficacité et/ou futilité, et des designs adaptatifs à trois bras avec sélection de traitement. Nous avons montré qu'une analyse intermédiaire avec une règle d'arrêt pour futilité était associé à un gain supplémentaire et à une meilleure maitrise du risque, contrairement aux règles d'arrêt pour efficacité qui ne permettent pas d'améliorer la performance. Les séries d'essais à trois bras sont systématiquement plus performants que les séries d'essais à deux bras. Dans la troisième de la thèse, nous avons étudié les essais randomisés évaluant un algorithme de traitement plutôt que l'efficacité d'un seul traitement. Le traitement expérimental est déterminé selon la mutation. Nous avons comparé deux méthodes basées sur le modèles de Cox à effets aléatoires pour l'estimation de l'effet traitement dans chaque mutation : Maximum Integrated Partial Likellihood (MIPL) en utilisant le package coxme et Maximum H-Likelihood (MHL) en utilisant le package frailtyHL. La performance de la méthode MIPL est légèrement meilleure. En présence d'un effet traitement hétérogène, les deux méthodes sousestime l'effet dans les mutations avec un large effet, et le surestime dans les mutations avec un modeste effet<br>Large sample sizes are required in randomized trials designed to meet typical one-sided α-level of 0.025 and at least 80% power. This may be unachievable in a reasonable time frame even with international collaborations. It is either because the medical condition is rare, or because the trial focuses on an uncommon subset of patients with a rare molecular subtype where the treatment tested is deemed relevant. We simulated a series of two-arm superiority trials over a long research horizon (15 years). Within the series of trials, the treatment selected after each trial becomes the control treatment of the next one. Different disease severities, accrual rates, and hypotheses of how treatments improve over time were considered. We showed that compared with two larger trials with the typical one-sided α-level of 0.025, performing a series of small trials with relaxed α-levels leads on average to larger survival benefits over a long research horizon, but also to higher risk of selecting a worse treatment at the end of the research period. We then extended this framework with more 'flexible' designs including interim analyses for futility and/or efficacy, and three-arm adaptive designs with treatment selection at interim. We showed that including an interim analysis with a futility rule is associated with an additional survival gain and a better risk control as compared to series with no interim analysis. Including an interim analysis for efficacy yields almost no additional gain. Series based on three-arm trials are associated with a systematic improvement of the survival gain and the risk control as compared to series of two-arm trials. In the third part of the thesis, we examined the issue of randomized trials evaluating a treatment algorithm instead of a single drugs' efficacy. The treatment in the experimental group depends on the mutation, unlike the control group. We evaluated two methods based on the Cox frailty model to estimate the treatment effect in each mutation: Maximum Integrated Partial Likellihood (MIPL) using package coxme and Maximum H-Likelihood (MHL) using package frailtyHL. MIPL method performs slightly better. In presence of a heterogeneous treatment effect, the two methods underestimate the treatment effect in mutations where the treatment effect is large, and overestimates the treatment effect in mutations where the treatment effect is small
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El, Ghosh Mirna. "Automatisation du raisonnement et décision juridiques basés sur les ontologies." Thesis, Normandie, 2018. http://www.theses.fr/2018NORMIR16/document.

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Le but essentiel de la thèse est de développer une ontologie juridique bien fondée pour l'utiliser dans le raisonnement à base des règles. Pour cela, une approche middle-out, collaborative et modulaire est proposée ou des ontologies fondationnelles et core ont été réutilisées pour simplifier le développement de l'ontologie. L’ontologie résultante est adoptée dans une approche homogène a base des ontologies pour formaliser la liste des règles juridiques du code pénal en utilisant le langage logique SWRL<br>This thesis analyses the problem of building well-founded domain ontologies for reasoning and decision support purposes. Specifically, it discusses the building of legal ontologies for rule-based reasoning. In fact, building well-founded legal domain ontologies is considered as a difficult and complex process due to the complexity of the legal domain and the lack of methodologies. For this purpose, a novel middle-out approach called MIROCL is proposed. MIROCL tends to enhance the building process of well-founded domain ontologies by incorporating several support processes such as reuse, modularization, integration and learning. MIROCL is a novel modular middle-out approach for building well-founded domain ontologies. By applying the modularization process, a multi-layered modular architecture of the ontology is outlined. Thus, the intended ontology will be composed of four modules located at different abstraction levels. These modules are, from the most abstract to the most specific, UOM(Upper Ontology Module), COM(Core Ontology Module), DOM(Domain Ontology Module) and DSOM(Domain-Specific Ontology Module). The middle-out strategy is composed of two complementary strategies: top-down and bottom-up. The top-down tends to apply ODCM (Ontology-Driven Conceptual Modeling) and ontology reuse starting from the most abstract categories for building UOM and COM. Meanwhile, the bottom-up starts from textual resources, by applying ontology learning process, in order to extract the most specific categories for building DOM and DSOM. After building the different modules, an integration process is performed for composing the whole ontology. The MIROCL approach is applied in the criminal domain for modeling legal norms. A well-founded legal domain ontology called CriMOnto (Criminal Modular Ontology) is obtained. Therefore, CriMOnto has been used for modeling the procedural aspect of the legal norms by the integration with a logic rule language (SWRL). Finally, an hybrid approach is applied for building a rule-based system called CORBS. This system is grounded on CriMOnto and the set of formalized rules
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Ananthakrishnan, Revathi Nayantara. "On the designs of early phase oncology studies." Thesis, 2017. https://hdl.handle.net/2144/27175.

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This thesis focuses on the design, statistical operating characteristics and interpretation of early phase oncology clinical trials. Anti-cancer drugs are generally highly toxic and it is imperative to deliver a dose to the patient that is low enough to be safe but high enough to produce a clinically meaningful response. Thus, a study of dose limiting toxicities (DLTs) and a determination of the maximum tolerated dose (MTD) of a drug that can be used in later phase trials is the focus of most Phase I oncology trials. We first comprehensively compare the statistical operating characteristics of various early phase oncology designs, finding that all the designs examined select the MTD more accurately when there is a clear separation between the true DLT rate at the MTD and the rates at the dose levels immediately above and below. Among the rule-based designs studied, we found that the 3+3 design under-doses a large percentage of patients and is not accurate in selecting the MTD for all the cases considered. The 5+5 a design picks the MTD as accurately as the model based designs for the true DLT rates generated using the chosen log-logistic and linear dose-toxicity curves, but requires enrolling a larger number of patients. The model based designs examined, mTPI, TEQR, BOIN, CRM and EWOC designs, perform well on the whole, assign the maximum percentage of patients to the MTD, and pick the MTD fairly accurately. However, the limited sample size of these Phase I oncology trials makes it difficult to accurately predict the MTD. Hence, we next study the effect of sample size and cohort size on the accuracy of dose selection in early phase oncology designs, finding that an adequate sample size is crucial. We then propose some integrated Phase 1/2 oncology designs, namely the 20+20 accelerated titration design and extensions of the mTPI and TEQR designs, that consider both toxicity and efficacy in dose selection, utilizing a larger sample size. We demonstrate that these designs provide an improvement over the existing early phase designs.<br>2019-12-01T00:00:00Z
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Books on the topic "Rule based oncology designs"

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1935-, Lasker G. E., International Institute for Advanced Studies in Systems Research and Cybernetics., and International Conference on Systems Research, Informatics and Cybernetics (8th : 1996 : Baden-Baden, Germany), eds. Advances in database and expert systems: Environmental information systems, expert diagnostic systems, evaluating and improving diagnostic knowledge-bases, databases for intelligent multimedia presentations, knowledge-based discovery in databases, transaction recovery in multidatabase systems, rapid database prototyping, relational designs for storage & manipulation of musical notes, rule-based diagnostic systems quality assurance, automatic referencing of notational labels. International Institute for Advanced Studies in Systems Research and Cybernetics, 1996.

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Book chapters on the topic "Rule based oncology designs"

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Daimon, Takashi, Akihiro Hirakawa, and Shigeyuki Matsui. "Rule-Based Designs Considering Toxicity Alone." In Dose-Finding Designs for Early-Phase Cancer Clinical Trials. Springer Japan, 2019. http://dx.doi.org/10.1007/978-4-431-55585-8_2.

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Luteberget, Bjørnar, Christian Johansen, and Martin Steffen. "Rule-Based Consistency Checking of Railway Infrastructure Designs." In Lecture Notes in Computer Science. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-33693-0_31.

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Simon, Noah. "Bayesian, Utility-Based, Adaptive Enrichment Designs with Frequentist Error Control." In Frontiers of Biostatistical Methods and Applications in Clinical Oncology. Springer Singapore, 2017. http://dx.doi.org/10.1007/978-981-10-0126-0_8.

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Luteberget, Bjørnar, Christian Johansen, Claus Feyling, and Martin Steffen. "Rule-Based Incremental Verification Tools Applied to Railway Designs and Regulations." In FM 2016: Formal Methods. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-48989-6_49.

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Ayzenshtadt, Viktor, Christoph Langenhan, Johannes Roith, et al. "Comparative Evaluation of Rule-Based and Case-Based Retrieval Coordination for Search of Architectural Building Designs." In Case-Based Reasoning Research and Development. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-47096-2_2.

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"Designs Based on Toxicity and Response." In Handbook of Statistics in Clinical Oncology. Chapman and Hall/CRC, 2005. http://dx.doi.org/10.1201/9781420027761-13.

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Petroni, Gina, and Mark Conaway. "Designs Based on Toxicity and Response." In Handbook of Statistics in Clinical Oncology, Third Edition. Chapman and Hall/CRC, 2012. http://dx.doi.org/10.1201/b11800-11.

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Conaway, Mark, and Gina Petroni. "Designs Based on Toxicity and Response." In Handbook of Statistics in Clinical Oncology, Second Edition. Chapman and Hall/CRC, 2005. http://dx.doi.org/10.1201/9781420027761.ch7.

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O’Quigley, John, and Alexia Iasonos. "Dose-Finding Designs Based on the Continual Reassessment Method." In Handbook of Statistics in Clinical Oncology, Third Edition. Chapman and Hall/CRC, 2012. http://dx.doi.org/10.1201/b11800-4.

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Jacobsen, Paul B., and Wynne E. Norton. "The Role of Implementation Science in Advancing Psychosocial Cancer Care." In Psycho-Oncology, edited by William S. Breitbart and Phyllis N. Butow. Oxford University Press, 2021. http://dx.doi.org/10.1093/med/9780190097653.003.0051.

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Despite considerable evidence that psychosocial care can effectively reduce distress in patients with cancer, many individuals who could benefit from these services do not receive them. This situation reflects, in part, the general lack of studies informed by implementation science that are designed specifically to promote the adoption of evidence-based models of psychosocial care as part of routine clinical practice. Thus, part of the solution involves expanding the scope of research in psychosocial oncology to include designing and conducting pragmatic clinical trials and using hybrid designs to simultaneously evaluate clinical effectiveness and barriers and facilitators of implementation. Use of these approaches holds considerable potential for promoting more widespread adoption of evidence-based models of care and providing stronger support for standards and policies related to the psychosocial care of people with cancer.
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Conference papers on the topic "Rule based oncology designs"

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Agarwal, Abhinav, and Arvind. "Leveraging rule-based designs for automatic power domain partitioning." In 2013 IEEE/ACM International Conference on Computer-Aided Design (ICCAD). IEEE, 2013. http://dx.doi.org/10.1109/iccad.2013.6691139.

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Martínez-Ortiz, Iván, José Luis Sierra, and Baltasar Fernández-Manjón. "Translating e-learning Flow-Oriented Activity Sequencing Descriptions into Rule-Based Designs." In 2009 Sixth International Conference on Information Technology: New Generations. IEEE, 2009. http://dx.doi.org/10.1109/itng.2009.125.

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Kochummen, Sherin A., N. E. Jaffar, and Nasar A. "Model Reference Adaptive Controller designs of steam turbine speed based on MIT Rule." In 2015 International Conference on Control Communication & Computing India (ICCC). IEEE, 2015. http://dx.doi.org/10.1109/iccc.2015.7432861.

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Bottura, C. P., and J. V. da Fonseca Neto. "Rule-based decision-making unit for eigenstructure assignment via parallel genetic algorithm and LQR designs." In Proceedings of 2000 American Control Conference (ACC 2000). IEEE, 2000. http://dx.doi.org/10.1109/acc.2000.878944.

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Guedes, Ítalo, and Max Andrade. "Automatic Rule-Based Checking for the Approval of Building Architectural Designs of Airport Passenger Terminals based on BIM." In 37 Education and Research in Computer Aided Architectural Design in Europe and XXIII Iberoamerican Society of Digital Graphics, Joint Conference (N. 1). Editora Blucher, 2019. http://dx.doi.org/10.5151/proceedings-ecaadesigradi2019_613.

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Russell, D. M., and S. P. Manoochehri. "A Two Dimensional Rule-Based Shape Synthesis Method." In ASME 1989 Design Technical Conferences. American Society of Mechanical Engineers, 1989. http://dx.doi.org/10.1115/detc1989-0093.

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Abstract The objective of this study is to form two-dimensional structural/mechanical parts under general loading and restraint conditions. The designs created are of minimum weight with the stresses throughout the parts as close to the allowable limit as possible. The study uses a thresholding approach with minimal designer intervention for generating optimal configurations. The process begins with the user creating an initial design which encompasses all the specified loads and restraints. Finite element techniques are employed to discretize the part geometry. Then a set of heuristics are utilized for shape modification, by removing elements from the finite element model. A Bi-Directional Thresholding technique, BDT, is developed that determines which elements ought to be removed. After BDT is performed element connectivity is checked and maintained. A two-step connectivity check algorithm is implemented which locates and resolves major (complete) as well as minor (partial) losses in connectivity. This procedure, unlike most common shape optimization methods, is capable of quickly making very large changes in the geometry of the part. It is able to create holes in the geometry, where none existed in the initial shape, in order to produce a better design.
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Rumpold, Adrian, and Bernhard Bauer. "A Metamodel and Model-based Design Rule Checking DSL for Verification and Validation of Electronic Circuit Designs." In 7th International Conference on Model-Driven Engineering and Software Development. SCITEPRESS - Science and Technology Publications, 2019. http://dx.doi.org/10.5220/0007381303150322.

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Rumpold, Adrian, and Bernhard Bauer. "A Metamodel and Model-based Design Rule Checking DSL for Verification and Validation of Electronic Circuit Designs." In 7th International Conference on Model-Driven Engineering and Software Development. SCITEPRESS - Science and Technology Publications, 2019. http://dx.doi.org/10.5220/0007381303170324.

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Rajavendra Reddy, Gaurav, Jin Wallner, Katherina Babich, and Yiorgos Makris. "Pattern Matching Rule Ranking Through Design of Experiments and Silicon Validation." In ISTFA 2018. ASM International, 2018. http://dx.doi.org/10.31399/asm.cp.istfa2018p0443.

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Abstract Continued technology scaling has led to exposure of many ‘weak-points’ in the designs fabricated in some of the most advanced technology nodes. Weak-points are certain layout patterns which are found to be sensitive to process non-idealities and have a higher tendency to cause defects. They may be coded in the form of Pattern Matching (PM) rules and included within the Design for Manufacturability Guidelines (DFMGs) to ensure product manufacturability. Often, during Integrated Circuit (IC) design, a trade-off is made between meeting performance specifications and complying with DFMGs. As a result, designs may reach the foundry with some DFMG violations. Fixing such violations generally causes a ‘ripple effect’ where one change requires many changes in other metal layers, making the process tedious. Therefore, providing a ranked list of guidelines to the designers helps them in assessing the criticality of violations, prioritizing, and fixing them accordingly. Past research suggests using diagnosis data to determine the impact of DFMG violations. However, this is a reactive approach wherein DFMGs are ranked only based on their hard-defect causing nature. To make the ranking process more robust, we propose a proactive silicon validation based approach which not only considers the yield loss due to hard-defects but also takes into account the parametric and reliability degradation caused by DFMG violations. We evaluate the effectiveness of the proposed methodology through on-silicon experiments on an advanced Fully-Depleted Silicon-On-Insulator (FD-SOI) technology node.
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Teeters, Jim, Robert Ranzenbach, and Martyn Prince. "Changes to Sail Aerodynamics in the IMS Rule." In SNAME 16th Chesapeake Sailing Yacht Symposium. SNAME, 2003. http://dx.doi.org/10.5957/csys-2003-005.

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US Sailing, the Offshore Racing Council (ORC), the Glenn L. Martin Wind Tunnel (GLMWT), Quantum Sail Design Group (QSDG), the Wolfson Unit and North Sails have collaborated on a series of wind tunnel test programs to investigate the performance of both upwind and offwind sails. These programs were initiated in response to perceived inequities in the ratings of boats of various rig designs sailing under the International Measurement System (IMS). Observations of on-the-water performance have lead to the conclusion that there are biases within the rule with respect to rig planform design. Specifically, it has been concluded that large spinnakers are penalized so that a fractional rig, with its small spinnaker, is favored when sailing offwind, that there are un-rated benefits to a masthead rig upwind, and that there are errors in the relative handicapping of overlapping and non-overlapping jibs. The IMS Rule uses a Velocity Prediction Program (VPP) in which sail forces are represented by algorithms that are based on a combination of science and reverse engineering from the measured sailing performance of real boats. The results of investigations at both GLMWT and Wolfson have been used to modify this IMS aerodynamic model, thereby reducing the pre-existing biases.
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