By James Des-Rosiers

Cybersecurity Considerations for Connected Medical Devices and the “Internet of Medical Things”

Med-Tech & Medical Device
Cybersecurity for IOmT connected medical devices. Advancements in technology of the past few decades has led to the development of devices capable of connecting to one another via networks such as Wi-Fi and Bluetooth, allowing them to create, transmit and receive data between one another. Medical technology (Medtech) companies have utilised these features to develop connected medical devices. These devices…
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By Sophia Puliasis

The Role of Precision Medicine in Drug Development and Clinical Trials

Clinical Trials, Pharma & Drug Development
With the help of precision medicine, or personalised medicine, modern medicine has moved away from a ‘one size fits all’ approach to treating disease and towards therapeutic approaches that are tailored to individuals and subgroups. These treatments are designed to be more efficacious due to targeting population subgroups based on their genetic or molecular nuances, rather than operating on the…
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By Rosetta Aires

Mini Report: Why do clinical trials fail? 

Clinical Trials
Overview Clinical studies are time-consuming, expensive, and frequently pose challenges for participants and sponsors alike. This article explores some of the numerous factors contributing the failure of a clinical study and offers suggestions on how to increase the likelihood of designing and carrying out effective clinical trials.Pharmaceutical and medical device clinical trials present several chances for failure. Failures can occur…
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By Henry Budds

Emerging use-cases for AI in clinical trials

Clinical Trials
Overview Clinical trials are becoming more expensive where, according to a Deloitte’s report1, the average cost to get a drug to market in the USA was $1.188 billion in 2010, and $1.981 billion in 2019. This increase in cost reflects the difficulties that are associated with current linear clinical trial designs. Clinical trials can take a long time due to…
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By Sabine Dreibe

4 common study designs for clinical trials

Clinical Trials
Clinical trial design is an important aspect of interventional trials that serves to optimise, ergonomise and economise the clinical trial conduct. The goals of a clinical trial, whether medtech or pharma, can encompass assessment of safety, dosage optimisation, evaluation of efficacy or accuracy and comparison to existing treatments or diagnostics. This of course varies with the phase of the trial.…
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By Sabine Dreibe
Bayesian approach for sample size estimation and re-adjustment in clinical trials

Bayesian approach for sample size estimation and re-adjustment in clinical trials

Uncategorized
            Accurate sample size calculation plays an important role in clinical research. Sample size in this context simply refers to the number of human patients, wheather healthy or diseased, taking part in the study. Clinical studies conducted using an insufficient sample size can lack the statistical power to adequately evaluate the treatment of interest, whereas a superfluous sample size can…
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By Sabine Dreibe

Medical Device Clinical Trials vs Pharmaceutical Clinical Trials – What’s the Difference?

Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development
Medical devices and drugs share the same goal - to safely improve the health of patients. Despite this, substantial differences can be observed between the two. Principally, drugs interact with biochemical pathways in human bodies while medical devices can encompass a wide range of different actions and reactions, for example, heat, radiation (Taylor and Iglesias, 2009). Additionally, medical devices encompass…
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By Anatomise Biostats

Dynamic Systems Modelling and Complex Adaptive Systems (CAS) Techniques in Biomedicine and Public Health

Uncategorized
Dynamical systems modelling is a mathematical approach to studying the behaviour of systems that change over time. These systems can be physical, biological, economic, or social in nature, and they are typically characterized by a set of variables that evolve according to certain rules or equations. CAS (Complex Adaptive Systems) models are a specific type of dynamical systems model that…
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By Sarah Baker

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

Uncategorized
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…
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