Adaptive trial design: Its growing role in clinical research and implications for pharmacists

作者：Cirulli Joshua^*; McMillian Wesley D; Saba Mojdeh; Stenehjem David

来源：American Journal of Health-System Pharmacy, 2011, 68(9): 807-813.

DOI：10.2146/ajhp100298

• Clinical studies
• Food and Drug Administration (US)
• Methodology
• Pharmacists
• Product development
• Regulations
• Research

Purpose. Current trends and recent developments in use of adaptive trial design methodology for pharmaceutical research, as well as barriers to wider acceptance and implications for pharmacists, are discussed.
Summary. Traditional clinical drug trials typically take many months or years to complete. In contrast, trials incorporating adaptive design elements allow researchers to make midstudy adjustments so that trial objectives are addressed more efficiently. Properly designed adaptive trials can enable researchers to conclude trials of unsuccessful treatments earlier or bring effective drugs to market sooner, improving patient safety and yielding substantial time. and cost savings. Challenges and concerns with adaptive trial methodology include inadequate knowledge of adaptive design techniques among health care professionals and increased potential for bias or misinterpretation of trial results stemming from earlier access to data. Over the past decade, U.S. and European regulatory bodies have issued a number of documents to better define acceptable practices for designing, conducting, and reporting the results of adaptive trials, including updated Food and Drug Administration guidance released in 2010. Pharmacists need to stay current with developments in the field to properly assess and interpret trial results.
Conclusion. Adaptive trial design is an emerging study methodology that allows for design modifications during a study, with the objective of implementing trial data as early as possible for the benefit of patients and the drug development process.

• 出版日期2011-5-1