Emerging use-cases for AI in 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 difficulty in finding suitable/eligible patients for each study and…
4 common study designs for 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. For phase III or IV trials the goal is…
Bayesian approach for sample size estimation and re-adjustment in clinical trials
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 unnecessarily waste limited resources. Various methods can be…
Clinical Trial Phases in Drug Development
The development of new drugs starts far before they are even seen in clinical trials. The discovery of multiple candidate drugs occur early on in the development process, often as a result of new information about how a disease functions, large-scale screening of small molecules, or the release of a new technology. After a promising drug has been found, pre-clinical studies can be performed. A pre-clinical study for a…
Medical Device Clinical Trials vs Pharmaceutical Clinical Trials – What’s the Difference?
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 not only therapeutic devices but diagnostic devices, as well…