Treatment-Adaptive vs Response-Adaptive Randomisation: A Practical Guide for Medtech Trials

Medical device trials increasingly incorporate adaptive randomisation to improve efficiency and patient outcomes. Two main approaches have emerged: treatment-adaptive randomisation (TAR), which modifies allocation probabilities at pre-planned interim analyses, and response-adaptive randomisation (RAR), which updates allocations continuously based on patient outcomes. The choice between these methods depends on trial characteristics including endpoint timing, data infrastructure, regulatory requirements, and scientific objectives.…
Read More

Causal Inference for Precision Medicine in Medtech R&D and Clinical Studies

Precision medicine is reshaping the landscape of medtech by tailoring treatments and diagnostics to each patient’s unique genetic, molecular, and clinical profile. As innovative devices and diagnostics enter the market, it becomes critical to understand not only whether they work, but why they work. Causal inference offers a robust statistical framework for distinguishing true treatment effects from mere associations, a…
Read More

Analytics for Precision Medicine in Medtech R&D and Clinical Trials

Precision medicine is transforming healthcare by allowing treatments and diagnostics to be tailored to the unique genetic, molecular, and clinical profiles of individual patients. As research and clinical evaluation evolves, sophisticated analytics have become essential for integrating complex datasets, optimising study designs, and supporting informed decision-making. This article will explore 3 core quantitative approaches core to supporting the development of…
Read More

Expert Opinion: Why Biostatistics Qualifications Matter in Med-Tech Industry Clinical Trials.

Consider the consequences if a medical doctor, without a formal medical education or licensing, were to diagnose and treat patients. Such a doctor might misunderstand symptoms, choose the wrong treatments, or even harm patients due to lack of understanding and experience. Similarly, an unqualified biostatistician might incorrectly analyse data, misinterpret statistical significance, or fail to recognise biases and patterns essential…
Read More

The role of Biostatisticians, Bioinformaticians & other Data Experts in Clinical Research

As a medical researcher or a small enterprise in the life sciences industry, you are likely to encounter many experts using statistical and computational techniques to study biological, clinical and other health data. These experts can come from a variety of fields such as biostatistics, bioinformatics, biometrics, clinical data science and epidemiology. Although these fields do overlap in certain ways…
Read More

Medical Device Categorisation, Classification and Regulation in the United Kingdom

Contributor: Sana Shaikh In this article Overview of medical device categorisations and classifications for regulatory purposes in the United Kingdom Summary of medical devices categorisations based on type, usage and risk potential during use as specified in the MDR and IVDR. The class of medical device and its purpose determines the criteria required to meet regulatory approval. All medical devices…
Read More

Complex Adaptive Systems (CAS) Approach to Biomedicine & Public Health

While a majority of biomedical and public health research still maintains a linear reductive approach to arrive at empiric insight, reality is in most cases neither of these things. A complex adaptive systems approach, like reality, is non-linear and high dimensional. There are many benefits from taking a linear cause-effect reductivist approach in that the complex problem and it’s solution…
Read More

Master Protocols for Clinical Trials

Part 1: Basket & Umbrella Trial Designs Introduction As the clinical research landscape becomes ever more complex and interdisciplinary alongside an evolving genomic and biomolecular understanding of disease, the statistical design component that underpins this research must adapt to accommodate this. Accuracy of evidence and speed with which novel therapeutics are brought to market remain hurdles to be surmounted. While…
Read More

Distributed Ledger Technology for Clinical & Life Sciences Research: some Use-Cases for Blockchain & Directed Acyclic Graphs

Distributed ledger technology (DLT) such as blockchain has a myriad of use-cases in life sciences and clinical research. Distributed ledger technology (DLT) has the potential to solve a myriad of problems that currently plague data collection, management and access processes in clinical and life sciences research, including clinical trials. DLT is an innovative approach to operating in environments where trust…
Read More