Adaptive clinical trials sound like jargon but, as some of those experiencing health issues that mainstream medicine has been unable to resolve have found, they can be hugely beneficial.
Adaptive clinical trials – a simple explanation
An adaptive clinical trial is a clinical trial that does not proceed only within predefined parameters. Patient outcomes and reported side effects can influence the conduct of the trial protocol. By comparison, a normal clinical trial is designed to assess the safety and effectiveness of new medicines. Volunteers move through the process of a clinical trial following a four-phase series of stages, and there is usually no room for deviation from these.
What are the particular advantages of adaptive clinical trials?
Adaptive clinical trials are more flexible, particularly in the earliest stages of the development of a new drug or other treatment. They allow for greater variation in terms of dosage and method of application than would be permissible in normal clinical trials. Not only can this deliver earlier indications of a medication’s safety and effectiveness, it can also enable patient participants on the trial to have harmful or ineffective doses altered. This can have enormous attractions to those who worry that signing up for a clinical trial risks them being put on a placebo with no measurable medical effect. As a further benefit, adaptive clinical trials generally require fewer patient participants, thus saving on costs. The UK Clinical Trials Gateway is an excellent starting point for anyone wishing to learn more about clinical trials of whatever type.
What are the disadvantages of adaptive clinical trials?
An adaptive clinical trial tends to be more statistically complex to analyse. Scientists and clinicians also have to be very aware of the possibility of introducing positive bias into a study. Finally, it is crucial that everyone involved in an adaptive clinical trial understands the essential need for coordination and management between scientists, clinicians, trial managers, statisticians and regulators. Organisations such as http://www.richmondpharmacology.com, that work in this field are demonstrating an increasing awareness of the potential pitfalls and working hard to avoid or ameliorate them. And, as adaptive Phase 1 Clinical Studies become more frequently undertaken, this situation should only improve further.
Adaptive clinical trials or randomised control trials?
Currently, there is a definitive place for both. Interested individuals should research the available literature before committing either way.