Related papers: The i3+3 Design for Phase I Clinical Trials
Existing methods for arbitrary-shaped text detection in natural scenes face two critical issues, i.e., 1) fracture detections at the gaps in a text instance; and 2) inaccurate detections of arbitrary-shaped text instances with diverse…
As a future trend of healthcare, personalized medicine tailors medical treatments to individual patients. It requires to identify a subset of patients with the best response to treatment. The subset can be defined by a biomarker (e.g.…
Optimal experimental design approaches are seldom used in pre-clinical drug discovery. Main reasons for this lack of use are that available software tools require relatively high insight in optimal design theory, and that the…
We propose an incentive scheme based on intervention to sustain cooperation among self-interested users. In the proposed scheme, an intervention device collects imperfect signals about the actions of the users for a test period, and then…
Phase I dose-escalation trials constitute the first step in investigating the safety of potentially promising drugs in humans. Conventional methods for phase I dose-escalation trials are based on a single treatment schedule only. More…
We propose a frequentist adaptive phase 2 trial design to evaluate the safety and efficacy of three treatment regimens (doses) compared to placebo for four types of helminth (worm) infections. This trial will be carried out in four…
While artificial-intelligence-based methods suffer from lack of transparency, rule-based methods dominate in safety-critical systems. Yet, the latter cannot compete with the first ones in robustness to multiple requirements, for instance,…
RRULES is presented as an improvement and optimization over RULES, a simple inductive learning algorithm for extracting IF-THEN rules from a set of training examples. RRULES optimizes the algorithm by implementing a more effective mechanism…
Improving patient care safety is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients' death rate can be significantly reduced by computerizing medical best practice guidelines. To facilitate the…
Healthcare companies must submit pharmaceutical drugs or medical devices to regulatory bodies before marketing new technology. Regulatory bodies frequently require transparent and interpretable computational modelling to justify a new…
Design-based simulations - procedures that hold realized outcomes fixed and generate variation by resampling treatment assignment or shocks - are widely used in both methodological and applied work to assess inference procedures. This paper…
The multiple-biomarker classifier problem and its assessment are reviewed against the background of some fundamental principles from the field of statistical pattern recognition, machine learning, or the recently so-called "data science". A…
3D task planning has attracted increasing attention in human-robot interaction and embodied AI thanks to the recent advances in multimodal learning. However, most existing studies are facing two common challenges: 1) heavy reliance on…
Time-to-event endpoints are central to evaluate treatment efficacy across many disease areas. Many trial protocols include interim analyses within group-sequential designs that control type I error via spending functions or boundary…
An accurately identified maximum tolerated dose (MTD) serves as the cornerstone of successful subsequent phases in oncology drug development. Bayesian logistic regression model (BLRM) is a popular and versatile model-based dose-finding…
Mid-study design modifications are becoming increasingly accepted in confirmatory clinical trials, so long as appropriate methods are applied such that error rates are controlled. It is therefore unfortunate that the important case of…
Latency-insensitive design mitigates increasing interconnect delay and enables productive component reuse in complex digital systems. This design style has been adopted in high-level design flows because untimed functional blocks connected…
Bayesian adaptive designs have gained popularity in all phases of clinical trials with numerous new developments in the past few decades. During the COVID-19 pandemic, the need to establish evidence for the effectiveness of vaccines,…
Randomized controlled trials (RCTs) can be used to generate guarantees on treatment effects. However, RCTs often spend unnecessary resources exploring sub-optimal treatments, which can reduce the power of treatment guarantees. To address…
Seamless phase II/III trials have become a cornerstone of modern drug development, offering a means to accelerate evaluation while maintaining statistical rigor. However, most existing inference procedures are model-based, designed…