Adaptive design clinical trial is something to evaluate a medical device or treatment by observing, or you can say by measuring outcomes and side-effects. It modifies the parameters of the trial protocol by those observations. Modifications include dosage, sample size, drug undergoing trial, or maybe a cocktail mix.
Some cases of adaptive clinical trial design have become regular, which adds and drops therapies and patient groups as more information gained. It is essential to set a trial protocol before the trial starts as the protocol pre-specified the adaption schedule and processes.
The aim of adaptive clinical trial design says that it is more quickly to identify drugs or devices that have a quick heal effect. It is zero on patient populations for whom the drug is appropriate. The modification key is to adjust the dosing levels. There is probably no chance of consideration reaction of non-adverse patients until the clinical trial is completed.
Why do you need an adaptive clinical trial design?
- Firstly adaptive design clinical trials are designed.
- Then it is conducted as prescribed in the design.
- Lastly, once it’s ready, they are analyzed to pre-specified the analyzed plan.
This practice is very much straight forward but is not flexible. Adaptive clinical trial designs also have an alternative described as,
- Planning to be flexible
- Driving with one’s eyes open
- Taking insurance against assumptions
- It adds a linear loop to the design conducted by analyzing the sequence.
In the meantime, the data are allowed while the trial is on process also pre-specified changes can be made. These plans are different from the unplanned modifications.
Advantages of Adaptive Clinical Trial Design
The advantages of adaptive design clinical trials are promising, but the approach doesn’t work without challenges.
- Patient welfare can be increased by reducing exposure to ineffective and harmful treatments at the earliest point.
- The requirements of resources can be reduced for an adaptive clinical trial design series.
- Devices for drug and medical reach faster to the markets
- No waste of time and resources if devices or treatments are ineffective.
- Most of the disadvantages can be ignored or taken care of with careful and advanced planning.
If there are advantages, then it is sure you will face challenges and disadvantages too, like changes in treatment, imbalance randomization efforts, or statistical significance penalties.
The adaptive clinical trial design may offer critical advantages over conventionally designed trials. It includes the flexibility to make potential planned modifications to some aspects of study design. This will help achieve more information and resulting study outcomes.