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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