Large Simple Trials

EU: imi GetReal Glossary – Large simple trials are pragmatic, randomised clinical trials with minimal data collection protocols that are narrowly focused on clearly defined outcomes that are important to patients as well as clinicians. Their large sample size provides the adequate statistical power to detect a small difference in effects between treatments in a situation where a moderate difference in an important outcome may be important. Additionally, LST’s include follow-up that mimics normal clinical practice. LST’s are by definition pragmatic clinical trials. (See also “pragmatic clinical trials”) [Source: imi GetReal Glossary – 25 Oct 2016 (Adapted from Stroup 2011, Peto 1995)]* * Stroup, T.S., What can large simple trials do for psychiatry? Am J Psychiatry, 2011. 168(2): p. 117-9.; Peto, R., R. Collins, and R. Gray, Largescale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol, 1995. 48(1): p. 23-40; Clinical Trials Transformation Initiative. Large Simple Trials: Facilitating the Use of Large

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