The significance of Adaptive design for clinical trials

An adaptive design clinical trial is a clinical trial that generally evaluates a medical device or treatment only by observing participants and outcomes on a prescribed schedule which is usually done by modifying the parameters of the trial protocol in combination with the collected observations or data. The adaptation process is done throughout the trial in a step-by-step process as prescribed in the trial protocol. These modifications are generally done that include dosage, sample size, drug undergoing trial, patient selection criteria, and “cocktail” mix.

It’s significance

The main aim of an adaptive design clinical trials is to identify the drugs or devices more quickly and efficiently that have a therapeutic effect on the body and to minimize the disease on the patient populations for whom the drug is created. New drug development is generally a time-consuming and expensive process. There has also been stagnation in the development and creation of novel compounds. The erosion rate in clinical research is also on the rise in recent years.

One of the innovations suggested recently was the adaptive design clinical trials are a method of promoting the introduction of pre-specified modifications in the design or statistical procedures undertaken in an ongoing trial that generally depends on the data produced from an experiment done makes the prosecution more flexible. The adaptive design trials are usually proposed to boost clinical research by cutting cost as well as time.

Concept of adaptive design clinical trials

The concept of adaptive design clinical trials is there for more than 40 years, but there is still a lack of uniformity and understanding on this crisis. This review generally highlights essential adaptive designed procedures, thereby covering the regulatory positions on a problem.

In recent years, the use of adaptive design methods in clinical research and development is based on collected data which has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can generally be classified into three categories that are prospective, concurrent, and retrospective adaptive designs. An adaptive design always allows modifications made to trials and the statistical procedures for the ongoing clinical trials. In addition to the trials on the target population for whom medicines were created, significant trial adaptations or statistical methods of ongoing trials may also result in a different trial that is unable to address the scientific and medical questions the trial had the aim to answer.