Abstract
Clinical trials are the backbone of medical research, and are often the last step in the development of new therapies for use in patients. Prior to human testing, however, preclinical studies using animal subjects are usually performed in order to provide initial data on the safety and effectiveness of prospective treatments. These studies can be costly and time consuming, and may also raise concerns about the ethical treatment of animals when potentially harmful procedures are involved. Adaptive design is a process by which the methods used in a study may be altered while it is being conducted in response to preliminary data or other new information. Adaptive design has been shown to be useful in reducing the time and costs associated with clinical trials, and may provide similar benefits in preclinical animal studies. The purpose of this review is to summarize various aspects of adaptive design and evaluate its potential for use in preclinical research.
Highlights
Preclinical studies are an essential component of medical research, providing useful data on the efficacy and safety of prospective treatments prior to clinical trials
Elements of adaptive design have been in use for decades, but only recently have attempts been made to formally define it
Preclinical studies can be considered an exploratory phase of treatment development and may benefit from adaptive design methods as well
Summary
Preclinical studies are an essential component of medical research, providing useful data on the efficacy and safety of prospective treatments prior to clinical trials. May be limited by cost and ethical concerns. Statistical analysis is often performed at the conclusion of the study, and is limited by the quality of the data collected. These issues apply to animal studies as well. An alternative strategy is to allow changes to be made during the study based on intermediate results or new external data. This process is known as adaptive design, the benefits of which include lower cost, reduced development time, and improved care to test subjects. Various aspects of adaptive design—including its advantages and disadvantages as well as its logistic, financial, and regulatory implications—will be discussed with respect to its potential application to animal studies
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