title: The Potential of Adaptive Design in Animal Studies.
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.
authors.affiliation: Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield S10 2HQ, UK. arshad.majid@sheffield.ac.uk.
authors.forename: Arshad
authors.initials: A
authors.lastname: Majid
authors.affiliation: College of Pharmacy Institute of Pharmaceutical Science and Technology, Hanyang University, Ansan 426-791, Korea. onbae@hanyang.ac.kr.
authors.forename: Ok-Nam
authors.initials: ON
authors.lastname: Bae
authors.affiliation: Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield S10 2HQ, UK. Jessica.Redgrave@sth.nhs.uk.
authors.forename: Jessica
authors.initials: J
authors.lastname: Redgrave
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield S10 2HQ, UK. m.d.teare@sheffield.ac.uk.
authors.forename: Dawn
authors.initials: D
authors.lastname: Teare
authors.affiliation: Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield S10 2HQ, UK. Ali.Ali@sth.nhs.uk.
authors.forename: Ali
authors.initials: A
authors.lastname: Ali
authors.affiliation: Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield S10 2HQ, UK. zemkedan@gmail.com.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zemke
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D012107:Research Design
keywords: adaptive design; animal studies; preclinical research