Related papers: Estimands in Hematologic Oncology Trials
This paper primarily addresses a dataset relating to cellular, chemical and physical conditions of patients gathered at the time they are operated upon to remove colorectal tumours. This data provides a unique insight into the biochemical…
Clinical trials are an integral component of medical research. Trials require careful design to, for example, maintain the safety of participants, use resources efficiently and allow clinically meaningful conclusions to be drawn. Adaptive…
Prognosis after intracranial hemorrhage (ICH) is influenced by a complex interplay between imaging and tabular data. Rapid and reliable prognosis are crucial for effective patient stratification and informed treatment decision-making. In…
The estimands framework outlined in ICH E9 (R1) describes the components needed to precisely define the effects to be estimated in clinical trials, which includes how post-baseline "intercurrent" events (IEs) are to be handled. In…
Accurate International Classification of Diseases (ICD) coding is critical for clinical documentation, billing, and healthcare analytics, yet it remains a labour-intensive and error-prone task. Although large language models (LLMs) show…
Unstructured notes within the electronic health record (EHR) contain rich clinical information vital for cancer treatment decision making and research, yet reliably extracting structured oncology data remains challenging due to extensive…
We present SHIELD, a novel methodology for automated and integrated safety signal detection in clinical trials. SHIELD combines disproportionality analysis with semantic clustering of adverse event (AE) terms applied to MedDRA term…
Drug combination trials are increasingly common nowadays in clinical research. However, very few methods have been developed to consider toxicity attributions in the dose escalation process. We are motivated by a trial in which the…
The potential benefits of applying machine learning methods to -omics data are becoming increasingly apparent, especially in clinical settings. However, the unique characteristics of these data are not always well suited to machine learning…
It has recently become popular to define treatment effects for subsets of the target population characterized by variables not observable at the time a treatment decision is made. Characterizing and estimating such treatment effects is…
A novel and highly efficient computational framework for reconstructing binary-type images suitable for models of various complexity seen in diverse biomedical applications is developed and validated. Efficiency in computational speed and…
In cancer biomarker development, a key objective is to evaluate whether a new biomarker, when combined with an established one, improves early cancer detection compared to using the established biomarker alone. Incremental value is often…
Background: Drug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease areas, this is particularly true for Phase II / III cancer…
Treatment of cancer has rapidly evolved over time in quite dramatic ways, for example from chemotherapies, targeted therapies to immunotherapies and chimeric antigen receptor T-cells. Nonetheless, the basic design of early phase I trials in…
Clinical trials are an instrument for making informed decisions based on evidence from well-designed experiments. Here we consider adaptive designs mainly from the perspective of multi-arm Phase II clinical trials, in which one or more…
Clinical trials are a systematic endeavor to assess the safety and efficacy of new drugs or treatments. Conducting such trials typically demands significant financial investment and meticulous planning, highlighting the need for accurate…
This paper discusses the knowledge integration of clinical information extracted from distributed medical ontology in order to ameliorate a machine learning-based multi-label coding assignment system. The proposed approach is implemented…
Immunohistochemical (IHC) staining provides crucial molecular characterization of tissue samples and plays an indispensable role in the clinical examination and diagnosis of cancers. However, compared with the commonly used Hematoxylin and…
Recent FDA guidance on adaptive clinical trial designs defines bias as "a systematic tendency for the estimate of treatment effect to deviate from its true value", and states that it is desirable to obtain and report estimates of treatment…
The problem of named entity recognition in the medical/clinical domain has gained increasing attention do to its vital role in a wide range of clinical decision support applications. The identification of complete and correct term span is…