The Call for Responsible Regulations in Medical Device Innovation

In the seemingly fast-paced world of medical technology, the quest for innovation is ever-present. However, it is crucial to recognise that the engineering of medical devices should not mirror the recklessness and hubris of exploratory engineering exemplified by the recent Ocean Gate tragedy where the stubborn blinkeredness of figures like Stockton Rush is not kept in check by sufficiently stringent…
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Stata: Statistical Software for Regulatory Compliance in Clinical Trials

Stata is widely used in various research domains such as economics, biosciences, health and social sciences, including clinical trials. It has been utilised for decades in studies published in reputable scientific journals. While SAS has a longer history of being explicitly referenced by regulatory agencies such as the FDA, Stata can still meet regulatory compliance requirements in clinical trials. StataCorp…
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The Devil’s Advocate: Stata for Clinical Study Design, Data Processing, & Statistical Analysis of Clinical Trials.

Stata is a powerful statistical analysis software that offers some advantages for clinical trial and medtech use cases compared to the more widely used SAS software. Stata provides an intuitive and user-friendly interface that facilitates efficient data management, data processing and statistical analysis. Its agile and concise syntax allows for reproducible and transparent analyses, enhancing the overall research process with…
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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…
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Sex Differences in Clinical Trial Recruiting

The following article investigates several systematic reviews into sex and gender representation in individual clinical trial patient populations. In these studies sex ratios are assessed and evaluated by various factors such as clinical trial phase, disease type under investigation and disease burden in the population. Sex differences in the reporting of safety and efficacy outcomes are also investigated. In many…
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Estimating the Costs Associated with Novel Pharmaceutical development: Methods and Limitations.

Data sources for cost analysis of drug development R&D and clinical trials Cost estimates for pre-clinical and clinical development across the pharmaceutical industry differ based on several factors. One of these is the source of data used by each costing study to inform these estimates. Several studies use private data, which can include confidential surveys filled out by pharmaceutical firms/clinical…
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How much does developing a novel therapeutic cost? – Factors Affecting Drug Development Costs across the Pharma Industry: A mini-Report

Introduction Data evaluating the costs associated with developing novel therapeutics within the pharmaceutical industry can be used to identify trends over time and can inform more accurate budgeting for future research projects. However, the cost to develop a drug therapeutic is difficult to accurately evaluate, resulting in varying estimates ranging from hundreds of millions to billions of US dollars between…
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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…
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Regulation of Connected Medical Devices and IOmT

Collection and transmission of personal biologic and health information via IOmT connected medical devices requires regulatory oversight and has cybersecurity implications. Connected medical devices (CMDs) can produce and transmitting patient data, allowing their condition to be monitored by healthcare professionals. They are often used in decentralised clinical trials (DCTs) outside of the clinical trial site, allowing for participants who wouldn’t…
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