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Software development methods are usually not applied by the book. Companies are under pressure to continuously deploy software products that meet market needs and stakeholders' requests. To implement efficient and effective development…
Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questions related to designing platform trials - such as the impact…
Statistical prediction plays an important role in many decision processes such as university budgeting (depending on the number of students who will enroll), capital budgeting (depending on the remaining lifetime of a fleet of systems), the…
Academic research groups are treated as complex systems and their cooperative behaviour is analysed from a mathematical and statistical viewpoint. Contrary to the naive expectation that the quality of a research group is simply given by the…
The second industrial revolution saw the development of management methods tailored to the challenges of the times: firstly, the need for mass production, and then, the pursuit of improved quality and customer satisfaction, followed by a…
The experimental evaluation of the methods and concepts covered in software engineering has been increasingly valued. This value indicates the constant search for new forms of assessment and validation of the results obtained in Software…
Identifying subgroups, which respond differently to a treatment, both in terms of efficacy and safety, is an important part of drug development. A well-known challenge in exploratory subgroup analyses is the small sample size in the…
A research frontier has emerged in scientific computation, wherein numerical error is regarded as a source of epistemic uncertainty that can be modelled. This raises several statistical challenges, including the design of statistical…
Statistical methods are indispensable to scientific inference. However, there exists a longstanding tension across a wide range of scientific disciplines about the role that ``context'' should play in the application of statistical methods…
The community of program optimisation and analysis, code performance evaluation, parallelisation and optimising compilation has published since many decades hundreds of research and engineering articles in major conferences and journals.…
Contemporary statistical publications rely on simulation to evaluate performance of new methods and compare them with established methods. In the context of meta-analysis of log-odds-ratios, we investigate how the ways in which simulations…
Without quantitative data, deciding whether and how to use static analysis in a development workflow is a matter of expert opinion and guesswork rather than an engineering trade-off. Moreover, relevant data collected under real-world…
Quantitative systems pharmacology (QSP) models are increasingly applied to inform decision making across drug development and to support regulatory interactions within model informed drug development (MIDD). QSP supports a broad range of…
In recent years, evaluation of the quality of academic research has become an increasingly important and influential business. It determines, often to a large extent, the amount of research funding flowing into universities and similar…
For many decades, formal methods are considered to be the way forward to help the software industry to make more reliable and trustworthy software. However, despite this strong belief and many individual success stories, no real change in…
Group sequential designs drive innovation in clinical, industrial, and corporate settings. Early stopping for failure in sequential designs conserves experimental resources, whereas early stopping for success accelerates access to improved…
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…
Context: Formal methods (FMs) have been around for a while, still being unclear how to leverage their benefits, overcome their challenges, and set new directions for their improvement towards a more successful transfer into practice.…
As any scientific discipline, the software engineering (SE) research community strives to contribute to the betterment of the target population of our research: software producers and consumers. We will only achieve this betterment if we…
There is a widespread perception that pharmaceutical R&D is facing a productivity crisis characterised by stagnation in the numbers of new drug approvals in the face of increasing R&D costs. This study explores pharmaceutical R&D dynamics…