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…
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…
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 the speed with which novel therapeutics are brought to market remain hurdles to be surmounted. Traditionally, efficacy and non-inferiority clinical trials included broad disease…