Related papers: Statistical Methodology Groups in the Pharmaceutic…
Quantitative decision-making (QDM) principles address the issues related to the mapping of results to decisions, the synthesis of information and the quantification of uncertainty. Since the clinical drug development involves a succession…
The pharmaceutical industry has experienced increasing costs and sustained high attrition rates in drug development over the last years. One proposal that addresses this challenge from a statistical perspective is the use of quantitative…
Clinical trials are pivotal in the drug discovery process to determine the safety and efficacy of a drug candidate. The high failure rates of these trials are attributed to deficiencies in clinical model development and protocol design.…
Developing drugs for rare diseases presents unique challenges from a statistical perspective. These challenges may include slowly progressive diseases with unmet medical needs, poorly understood natural history, small population size,…
Clinical trials are an indispensable part of the drug development process, bridging the gap between basic research and clinical application. During the development of new drugs, clinical trials are used not only to evaluate the safety and…
There are several steps to confirming the safety and efficacy of a new medicine. A sequence of trials, each with its own objectives, is usually required. Quantitative risk metrics can be useful for informing decisions about whether a…
This special volume of Statistical Sciences presents some innovative, if not provocative, ideas in the area of reliability, or perhaps more appropriately named, integrated system assessment. In this age of exponential growth in science,…
Background The cost of drug discovery and development is substantial, with clinical trial outcomes playing a critical role in regulatory approval and patient care. However, access to large-scale, high-quality clinical trial outcome data…
The allocation of tasks can be seen as a success-critical management activity in distributed development projects. However, such task allocation is still one of the major challenges in global software development due to an insufficient…
The drug development process is a critical challenge in the pharmaceutical industry due to its time-consuming nature and the need to discover new drug potentials to address various ailments. The initial step in drug development, drug target…
Risk management often plays an important role in decision making under uncertainty. In quantitative risk management, assessing and optimizing risk metrics requires efficient computing techniques and reliable theoretical guarantees. In this…
We develop a method for assigning high-quality labels to unstructured text. This method is based on fine-tuning an efficient, open-source language model with data extracted from a large, proprietary language model. We apply this method to…
Managing software development productivity and effort are key issues in software organizations. Identifying the most relevant factors influencing project performance is essential for implementing business strategies by selecting and…
One of the essential requisites of any software industry is the development of customer satisfied products. However, accomplishing the aforesaid business objective depends upon the depth of quality of product that is engineered in the…
Bayesian statistics plays a pivotal role in advancing medical science by enabling healthcare companies, regulators, and stakeholders to assess the safety and efficacy of new treatments, interventions, and medical procedures. The Bayesian…
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…
Over the last 20 years, a very large number of startups have been launched, ranging from mobile application and game providers to enormous corporations that have started as tiny startups. Startups are an important topic for research and…
This article explores the critical role of statistical analysis in precision medicine. It discusses how personalized healthcare is enhanced by statistical methods that interpret complex, multidimensional datasets, focusing on predictive…
Many pharmaceutical companies face concerns with the maintenance of desired revenue levels. Sales forecasts for the current portfolio of products and projects may indicate a decline in revenue as the marketed products approach patent…
Big data are data on a massive scale in terms of volume, intensity, and complexity that exceed the capacity of standard software tools. They present opportunities as well as challenges to statisticians. The role of computational…