相关论文: Integration of Efficacy Biomarkers Together with T…
Gastric and oesophageal (OG) cancers are the leading causes of cancer mortality worldwide. In OG cancers, recent studies have showed that PDL1 immune checkpoint inhibitors (ICI) in combination with chemotherapy improves patient survival.…
Precision cancer medicine aims to determine the optimal treatment for each patient. In-vitro cancer drug sensitivity screens combined with multi-omics characterization of the cancer cells have become an important tool to achieve this aim.…
The Kaplan-Meier estimator (KM) is widely used in medical research to estimate the survival function from lifetime data. KM is a powerful tool to evaluate clinical trials due to simple computational requirements, a logrank hypothesis test,…
A platform trial with a master protocol provides an infrastructure to ethically and efficiently evaluate multiple treatment options in multiple diseases. Given that certain study drugs can enter or exit a platform trial, the randomization…
We propose a Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity, referred to as BOP2-TE, to improve the operating characteristics of the BOP2 design proposed by Zhou et al. (2017). BOP2-TE utilizes a…
We introduce a statistical procedure that integrates survival data from multiple biomedical studies, to improve the accuracy of predictions of survival or other events, based on individual clinical and genomic profiles, compared to models…
Background Identifying the right cut-off for continuous biomarkers in clinical trials is important to identify subgroups of patients who are at greater risk of disease or more likely to benefit from a drug. The literature in this area tends…
When to initiate treatment on patients is an important problem in many medical studies such as AIDS and cancer. In this article, we formulate the treatment initiation time problem for time-to-event data and propose an optimal individualized…
In traditional dose-finding studies, dose-limiting toxicity (DLT) is determined within a fixed time observation window where DLT is often defined as a binary outcome. In the setting of oncology dose-finding trials, often patients in…
Due to the contribution of drug-target binding kinetics to drug efficacy, there is a high level of interest in developing methods to predict drug-target binding kinetic parameters. During the review period, a wide range of enhanced sampling…
In this paper, we study a phase-space analysis of a mathematical model of tumor growth with an immune response. Mathematical analysis of the model equations with multipoint initial condition, regarding to dissipativity, boundedness of…
To optimize diffusion MRI acquisition protocols for IMPULSED model at clinical 3T scanner using Bayesian experimental design, enabling accurate cellular-scale parameter estimation under realistic scan time and scanner hardware constraints.…
Recent advances in biological research have seen the emergence of high-throughput technologies with numerous applications that allow the study of biological mechanisms at an unprecedented depth and scale. A large amount of genomic data is…
The US FDA's Project Optimus initiative that emphasizes dose optimization prior to marketing approval represents a pivotal shift in oncology drug development. It has a ripple effect for rethinking what changes may be made to conventional…
Tumor Treating Fields (TTFields) is an FDA approved treatment for specific types of cancer and significantly extends patients life. The intensity of the TTFields within the tumor was associated with the treatment outcomes: the larger the…
Various approaches to increase efficiency of antitumor therapy by a combination of vaccinotherapy, chemotherapy and surgical excision of primary tumor nodes, and also the comparative analyses of therapeutic and preventive application of…
In clinical trials, patients may discontinue treatments prematurely, breaking the initial randomization and, thus, challenging inference. Stakeholders in drug development are generally interested in going beyond the Intention-To-Treat (ITT)…
Mixed outcome endpoints that combine multiple continuous and discrete components to form co-primary, multiple primary or composite endpoints are often employed as primary outcome measures in clinical trials. There are many advantages to…
Mathematical oncology is a rapidly evolving interdisciplinary field that uses mathematical models to enhance our understanding of cancer dynamics, including tumor growth, metastasis, and treatment response. Tumor-immune interactions play a…
Tumor response, a binary variable, has historically been the main measure of antitumor activity for many cancer phase II single-arm trials. Simon two-stage designs are often used. Sargent et al. proposed a three-outcome trial design in this…