相关论文: CUI-MET: Clinical Utility Index Dose Optimization …

There has been an increasing interest in using cell and gene therapy (CGT) to treat/cure difficult diseases. The hallmark of CGT trials are the small sample size and extremely high efficacy. Due to the innovation and novelty of such…

The US Food and Drug Administration launched Project Optimus with the aim of shifting the paradigm of dose-finding and selection towards identifying the optimal biological dose that offers the best balance between benefit and risk, rather…

Background: More than 80% of U.S. cancer care is delivered in community settings, where survival remains worse than at academic centers. Clinicians must integrate genomics, staging, radiology, pathology, and changing guidelines, creating…

In early-phase cancer clinical trials, the limited availability of data presents significant challenges in developing a framework to efficiently quantify treatment effectiveness. To address this, we propose a novel utility-based Bayesian…

AI-driven precision oncology has the transformative potential to reshape cancer treatment by leveraging the power of AI models to analyze the interaction between complex patient characteristics and their corresponding treatment outcomes.…

The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maximum tolerable dose (MTD) to determining the optimal…

There are several different modalities, e.g., surgery, chemotherapy, and radiotherapy, that are currently used to treat cancer. It is common practice to use a combination of these modalities to maximize clinical outcomes, which are often…

To promote precision medicine, individualized treatment regimes (ITRs) are crucial for optimizing the expected clinical outcome based on patient-specific characteristics. However, existing ITR research has primarily focused on scenarios…

In this article, we propose a phase I-II design in two stages for the combination of molecularly targeted therapies. The design is motivated by a published case study that combines a MEK and a PIK3CA inhibitors; a setting in which higher…

Radiotherapy planning is a critical aspect of cancer treatment, where the optimal selection of beam directions and dose distributions significantly impacts treatment efficacy and patient outcomes. Traditionally, this process involves…

Healthcare applications are inherently multimodal, benefiting greatly from the integration of diverse data sources. However, the modalities available in clinical settings can vary across different locations and patients. A key area that…

Purpose: To develop a multi-criteria optimization framework for image guided radiotherapy. Methods: An algorithm is proposed for a multi-criteria framework for the purpose of patient setup verification decision processes. Optimal patient…

Phase I oncology trials aim to identify a safe dose - often the maximum tolerated dose (MTD) - for subsequent studies. Conventional designs focus on population-level toxicity modeling, with recent attention on leveraging pharmacokinetic…

Objective: Although medical imaging datasets are increasingly available, abnormal and annotation-intensive findings critical to lung cancer screening, particularly small pulmonary nodules, remain underrepresented and inconsistently curated.…

We propose a new integrated phase I/II trial design to identify the most efficacious dose combination that also satisfies certain safety requirements for drug-combination trials. We first take a Bayesian copula-type model for dose finding…

Pre-biopsy magnetic resonance imaging (MRI) is increasingly used to target suspicious prostate lesions. This has led to artificial intelligence (AI) applications improving MRI-based detection of clinically significant prostate cancer…

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…

A precise assessment of the risk of breast lesions can greatly lower it and assist physicians in choosing the best course of action. To categorise breast lesions, the majority of current computer-aided systems only use characteristics from…

The advancements in data acquisition, storage, and processing techniques have resulted in the rapid growth of heterogeneous medical data. Integrating radiological scans, histopathology images, and molecular information with clinical data is…

Background: Phase I trials desire to identify the maximum tolerated dose (MTD) early and proceed quickly to an expansion cohort or phase II trial for efficacy. We propose an early completion method based on multiple dosages to accelerate…